{ "lyophilized qPCR master mix formulation trehalose enzyme concentration": [ { "title": "Lyophilization of premixed COVID‐19 diagnostic RT‐qPCR ...", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8237061", "description": "by MJ Hammerling · 2021 · Cited by 21 — These formulations included a concentration gradient of 0–50 mg mL‐1 of trehalose, sucrose, or dextran alone, each lyoprotectant at 50 mg mL‐1", "position": 1 }, { "title": "Manufacturing and Formulation Development of ...", "url": "https://micronanoeducation.org/wp-content/uploads/2024/09/J-ATE-3-2-Manufacturing-and-Formulation-Development.pdf", "description": "Lyophilization of a Ready-to-Use RT-PCR mix with a similar enzyme requires a combination of Trehalose, Ficoll-400, and Gelatin [8]. 10% Trehalose and 0.1%", "position": 2 }, { "title": "Lyophilized Ready-to-Use Mix for the Real-Time Polymerase ...", "url": "https://pubs.acs.org/doi/abs/10.1021/acsabm.1c00131", "description": "by S Yang · 2021 · Cited by 24 — According to our results, the dried mix with the basic mixture and the additive formulation containing 5–15% w/v trehalose, 2–10% w/v °C) vs", "position": 3 }, { "title": "Evaluation of lyophilized PCR mixes stable at room ...", "url": "https://www.authorea.com/doi/full/10.22541/au.172959374.48638715/v1", "description": "by B Kocikova · 2024 · Cited by 1 — Our study revealed that 10% trehalose, 5% dextran and their combination, stabilized PCR mixes for the detection of porcine circovirus 2 (PCV2)", "position": 4 }, { "title": "Master Mixes for Molecular Ambient-Temperature Stable ...", "url": "https://www.meridianbioscience.com/uploads/Meridian-Master-Mixes-for-Molecular-Ambient-Temperature-Stable-Assays-1.pdf", "description": "VOLUME REACTIONS Aptamer Taq HS (glycerol free) (50 U/μL) MDX015 20 µL 50 mL 500 µL 500 mL DNA Polymerase Aptamer Taq HS (Glycerol Free) • \u0007 Highly suited to multiplex, high-throughput viral detection assays requiring high specificity • \u0007 No activation step - reduce an assay run time by up to 15 minutes • \u0007 Convenient room temperature reaction set-up • \u0007 High enzyme concentration (50 U/μL) compatible with lyophilization protocols PRODUCT HIGHLIGHTS Fast Hot-Start Comparison of qPCR performance [...] VOLUME REACTIONS Lyo-compatible MMLV-RT MDX042 8 µL 1,000 Rxn 80 µL 10,000 Rxn Reverse Transcriptase Lyo-compatible MMLV-RT • \u0007 High-concentration MMLV-RT suitable for incorporation into lyophilized RT-PCR assays • \u0007 Demonstrates high efficiency in RT-qPCR assays and high sensitivity detection of low copy number RNA targets Applications: 04/21 ISO 13485 Certified Connect with us: Ordering information: USA 5171 Wilfong Road Memphis, Tennessee 38134 Fax: +1 901-333-8223 Toll Free: +1 800 327 6299 [...] VOLUME REACTIONS Lyo-Ready™ qPCR Mix MDX021 5 mL 500 Rxn 100 mL 10,000 Rxn Lyo-Ready™ qPCR Mix 2.6x MDX023 4 mL 500 Rxn 100 mL 12,500 Rxn CMV EBV Cycle Cycle Amplification Plot Amplification Plot Adenovirus DNA Extraction Control Cycle Cycle Amplification Plot Amplification Plot Lyo-Ready Lyo-Ready™ qPCR Mix • \u0007 Ready-to-use and glycerol-free qPCR master mix formulated with a specialized blend of excipients • \u0007 Ideal for multiplex assays on automated high-throughput instruments • \u0007 Compatible", "position": 5 }, { "title": "TaqMan Lyo-Ready qPCR Master Mixes | Thermo Fisher Scientific - BR", "url": "https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/real-time-pcr-reagents/taqman-real-time-master-mixes/lyo-ready.html", "description": "| | | | | | | |\n --- --- --- \n| | TaqMan 2.5X Lyo-Ready 1-Step Master Mix with excipient | TaqMan 2.5X Lyo-Ready qPCR Master Mix with excipient | TaqMan 5X Lyo-Ready 1-Step Master Mix | TaqMan 5X Lyo-Ready 1-Step Master Mix with ROX | TaqMan 5X Lyo-Ready qPCR Master Mix | TaqMan 5X Lyo-Ready qPCR Master Mix with ROX |\n| Request a quote | | | | | | |\n| Target | RNA, DNA | DNA | RNA, DNA | RNA, DNA | DNA | DNA |\n| Concentration | 2.5X | 2.5X | 5X | 5X | 5X | 5X | [...] TaqMan 2.5X Lyo-Ready 1-Step Master Mix with excipient\n\nTaqMan 2.5X Lyo-Ready qPCR Master Mix with excipient\n\nTaqMan 5X Lyo-Ready 1-Step Master Mix\n\nTaqMan 5X Lyo-Ready 1-Step Master Mix with ROX\n\nTaqMan 5X Lyo-Ready qPCR Master Mix\n\nTaqMan 5X Lyo-Ready qPCR Master Mix with ROX\n\nTarget\n\nRNA, DNA\n\nDNA\n\nRNA, DNA\n\nRNA, DNA\n\nDNA\n\nDNA\n\nConcentration\n\n2.5X\n\n2.5X\n\n5X\n\n5X\n\n5X\n\n5X\n\nExcipient\n\nYes, pre-mixed\n\nYes, pre-mixed\n\nNone\n\nNone\n\nNone\n\nNone\n\nPassive reference dye\n\nNone\n\nNone\n\nNone\n\nROX\n\nNone\n\nROX [...] Reliable and storage-temperature-agnostic molecular diagnostics qPCR assays need to utilize reagents that are easily lyophilized and provide consistent performance even with non-ideal samples. TaqMan Lyo-Ready qPCR master mixes fulfill these requirements, making them highly suited to lyophilized qPCR assays using your chosen primers and probes.", "position": 6 } ], "freeze drying lyoprotectant trehalose sucrose mechanism protein stabilization": [ { "title": "Effectiveness of Lyoprotectants in Protein Stabilization During ...", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11510631", "description": "The important underlying mechanism of lyoprotectant is the interactions between the lyoprotectant and protein. Bonding between lyoprotectant and protein is another key contributor to enhance the stability of the protein conformation in the post-drying process. Hydrogen bonding with proteins is one of the key mechanisms by which lyoprotectants stabilize proteins. Lyoprotectants like sugars (e.g., sucrose, trehalose) and polyols (e.g., glycerol, sorbitol) can form hydrogen bonds with the polar [...] can effectively replace water molecules, forming hydrogen bonds with polar groups on protein surfaces. This substitution stabilizes the protein’s tertiary and secondary structures, mitigating the stress induced by drying and freezing processes. Studies have shown that trehalose forms fewer hydrogen bonds with proteins than sucrose, resulting in less disruption of protein structure, highlighting the importance of the specific interactions between lyoprotectants and proteins. Achieving a stable [...] shells that prevent aggregation by keeping protein molecules separate. When water is removed during freeze-drying, these shells can collapse, leading to protein aggregation and loss of function. Lyoprotectants, such as sugars (e.g., sucrose, trehalose), can mimic the hydration shells and provide a protective coating around the protein molecules, preventing their aggregation and maintaining their solubility in the dried state. Disaccharides like sucrose and trehalose are classic examples of", "position": 1 }, { "title": "Trehalose Crystallization During Freeze-Drying", "url": "https://www.researchgate.net/publication/231667623_Trehalose_Crystallization_During_Freeze-Drying_Implications_On_Lyoprotection", "description": "Lyoprotectants are stabilizers used to prevent denaturation of proteins during freeze-drying and subsequent storage. In order to be effective,", "position": 2 }, { "title": "Lyophilization Excipients: Sugars, Amino Acids & Surfactants for Protein Stability", "url": "https://allanchem.com/lyophilization-excipients-protein-stability", "description": "Water replacement and vitrification are two important methods for stabilizing proteins during freeze-drying. In water replacement, excipients such as sucrose or trehalose bind to the protein’s polar groups through hydrogen bonds. This interaction substitutes for the water molecules lost during the drying process, helping to preserve the protein’s natural structure. [...] The dual mechanisms of water replacement and vitrification are central to cryoprotectant optimization for biopharma stability. Sugars like trehalose and sucrose replace lost hydration and form a rigid matrix that minimizes protein movement and aggregation. Surfactants provide additional protection by reducing surface-induced aggregation risks, while buffers maintain the pH balance necessary for protein stability ( These mechanisms are vital for ensuring the integrity of proteins throughout the [...] ### Water Replacement and Hydrogen Bonding\n\nDuring freeze-drying, proteins lose their hydration shell, which is vital for maintaining their structure. Excipients like sucrose and trehalose step in to form hydrogen bonds with the protein’s polar groups, effectively mimicking the hydration shell and stabilizing the protein’s folded structure.", "position": 3 }, { "title": "Stabilizing Effect of Four Types of Disaccharide on the ...", "url": "https://www2.kaiyodai.ac.jp/~mwat/images/lab/63.lab.pdf", "description": "1887 Stabilization of Freeze-dried Protein by Disaccharide trehalose and sucrose formulations which exhibited no brown-ing change, there was a gradual loss of the relative LDH activity at the storage temperature of 60-C. The effect of trehalose and sucrose on the storage stability of LDH was almost comparable.\nIt should be noted that destabilization was not completely prevented at 60-C, even if the formulations were in glassy state. [...] to a number of its physical properties: high Tg (40), ability to form intermolecular hydrogen bonds (41), and low molecular mobility below Tg (33). However, it should be noted that after freeze-drying, the stabilizing effect of trehalose on LDH formulations was not unique compared to other disaccharides. On the other hand, it has been reported that the moisture of freeze-dried proteins can affect its stability both indirectly (plasticizer or reaction medium) and directly (reactant or product) [...] Conclusions. Taking the storage stability of freeze-dried proteins under the various conditions (temperature and RH) into consideration, trehalose is better suited as the stabilizer than other disaccharides.\nKEY WORDS: cryostabilization; disaccharide; freeze-drying; glass transition; lyostabilization; storage stability.", "position": 4 }, { "title": "Mechanism of protein stabilization by trehalose during ...", "url": "https://www.semanticscholar.org/paper/Mechanism-of-protein-stabilization-by-trehalose-by-H%C3%A9doux-Paccou/7a315e02074e85dec28b0650bc4db333d6b59adc", "description": "The ability of trehalose to make the protein more rigid was determined as responsible for the protein stabilization during a lyophilization cycle.", "position": 5 }, { "title": "Protective agent in freeze-drying", "url": "https://axispharm.com/protective-agent-in-freeze-drying", "description": "For example, 100mmol/L sucrose has the best protective effect on B-galactose enzyme, while the concentration of trehalose that provides the maximum protective effect on phosphofructokinase is 300mg/ml.The lowest concentration of sugar reported for maximum stabilization is one that is sufficient to form a monomolecular layer on the protein surface. [...] Compared with sucrose, trehalose has a higher glass transition temperature, lower hygroscopicity, and no reducing properties. These advantages all indicate that trehalose may have a broader application prospect. Macromolecules sugar appears to provide less protection against proteins than micromolecule sugar. Many studies have shown that polysaccharides with high molecular weight are not the best choice of lyophilized protectant. [...] agents for these unstable factors. Generally speaking, sugars and polyhydroxy compounds are the most commonly used freeze-dried protective agents. Among them, disaccharides such as sucrose and trehalose can show good protective effects on some proteins.", "position": 6 } ], "freeze drying cycle annealing collapse temperature Tg' lyophilization primary secondary drying": [ { "title": "Lyophilization Cycle Development: A Freeze-Drying Guide | IntuitionLabs", "url": "https://intuitionlabs.ai/articles/lyophilization-cycle-development", "description": "What is collapse temperature in freeze drying? Collapse temperature (Tc) is the temperature above which the freeze-concentrated amorphous matrix loses its structural rigidity during primary drying and physically deforms; it is measured by freeze-dry microscopy and is typically \"1 to 3°C higher than Tg' values,\" the glass transition temperature of the maximally freeze-concentrated solute (( [...] point\" (( Collapse temperature is typically 1 to 3 degrees Celsius above the glass transition temperature of the maximally freeze-concentrated solute (Tg'), measured respectively by freeze-dry microscopy and differential scanning calorimetry (( (( Because a one-degree increase in primary drying temperature can shorten drying time by roughly 10%, cycle developers push shelf temperature and chamber pressure as close to these limits as the equipment safely allows (( Modern process analytical [...] What is the difference between primary and secondary drying in lyophilization? Primary drying removes frozen (free) water by sublimation, converting ice directly to vapor under vacuum while the product remains below its critical formulation temperature; secondary drying removes unfrozen, bound water from the resulting amorphous solid matrix through desorption at a raised shelf temperature, typically completing \"in 3 to 6 h at shelf temperature 40 or 50°C\" once initiated ((", "position": 1 }, { "title": "JP5785077B2 - Freeze-drying above the collapse temperature - Google Patents", "url": "https://patents.google.com/patent/JP5785077B2/en", "description": "When the material was freeze-dried slightly above the collapse temperature (maintaining product temperature during primary drying at about −31 ° C.), the cycle time was reduced to 20 hours (FIG. 14). The residual moisture of the lyophilized material was 3.69 ± 0.13%, resulting in a low glass transition temperature of 44 ° C. The combination of the collapse phenomenon and the secondary drying temperature reduced from 40 ° C. (see FIG. 12) to 25 ° C. (see FIG. 14) contributed to the higher [...] ２種の凍結乾燥サイクルを実施した。一方のサイクルは、−１８℃の崩壊温度（崩壊の開始）より低温での一次乾燥ステップを包含し、もう一方は、崩壊温度よりかなり高いがマンニトールの融点より低い温度での一次乾燥ステップを包含する。第１サイクル（作業サイクル１、図７）は、収縮率が小さい良いケーク（図８）を製造する。第２サイクル（図９）は、非常に積極的な条件下で行われ、それによって、生成物温度は、ほぼ全一次乾燥ステップに関して−１８℃の崩壊温度より高くなった。しかし、ケーク外観（図１０）は、許容できるものであった。 Two lyophilization cycles were performed. One cycle involves a primary drying step at a temperature below the collapse temperature of −18 ° C. (onset of collapse) and the other involves a primary drying step at a temperature well above the [...] The baseline freeze dry cycle was carried out at a product temperature (Fig. 12) close to -37 ° C, well below the collapse temperature. Freezing was performed in an ethanol-dry ice bath and vials with frozen material were loaded onto precooled (−50 ° C.) shelves of a Benchmark 1000 freeze dryer (SP Industries, Gardner, NY). Primary drying was completed before the secondary drying ramp. The residual moisture of the lyophilized material was low, 0.08 ± 0.01%. Two types of glass transition", "position": 2 }, { "title": "Lyophilization Cycle Optimization | HTD Biosystems", "url": "https://www.htdcorp.com/services/lyophilization-services/lyophilization-cycle", "description": "The lyophilization process consists of three main stages: freezing, primary drying, and secondary drying. \n \nFreezing: During the freezing stage, the product is cooled to a temperature below its glass transition temperature (Tg) in order to freeze it and remove the water by sublimation. The rate and extent of freezing can be influenced by the temperature, humidity, and air flow conditions in the freeze dryer, as well as the product properties (e.g., concentration, viscosity, and Tg). [...] At HTD, we use the primary glass transition temperature (Tg) as an important parameter in the development of lyophilization cycles. Tg is the temperature at which a solid transitions from a glassy to a rubbery state, and it is a key factor in the stability and performance of lyophilized products. [...] Primary drying duration: The primary drying duration is the length of time that the primary drying stage is carried out. It can influence the rate and extent of water removal and the stability of the product during storage.\n Secondary drying temperature: The secondary drying temperature is the temperature at which the secondary drying stage is carried out. It can influence the moisture content of the product and the stability of the product during storage.", "position": 3 }, { "title": "Secondary Drying - an overview", "url": "https://www.sciencedirect.com/topics/engineering/secondary-drying", "description": "During this stage, frozen samples are maintained below the product collapse temperature and the eutectic melting temperature. The product collapse temperature is highly influenced by the Tg and is unique for each formulation. Below the Tg, the amorphous phase exists as glasslike material, inhibiting large-scale molecular movement. Therefore, sublimation efficiency during the primary drying stage is maximized by operating as close to Tg as possible yet below that temperature. If the Tg is [...] If the Tg is exceeded during the primary drying phase, it can result in cake collapses, which in turn can lower the rate of water sublimation/desorption, cause physicochemical changes in the product and resulting in an inferior product. Drying just below the Tg (at least 2–5°C) not only increases the efficiency of the primary drying phase, but also prevents cake collapses and results in more uniform distribution of bound water at the completion of the lyophilization process [41,46]. [...] low enough. At this stage, it is possible to increase the shelf temperature because the product has an increased thermal stability and a higher Tg owing to previous dehydration. However, the temperature must not be increased rapidly, so the ramp rate to the secondary drying temperature needs to be moderate (0.1–0.3°C/min) for amorphous substances to avoid surpassing the Tg of the lyophilized cake and avoid cake shrinkage [37,41,42].", "position": 4 }, { "title": "Practical Advice on Scientific Design of Freeze-Drying Process: 2023 Update", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC10661802", "description": "efficient excipient crystallization . Given all positive and negative factors, we recommend testing the annealing approach in the product development phase. Annealing temperatures between -15°C and -10°C for 3–5 h is recommended as a temperature range above Tg’ for most of the products that use lyophilization. Also, the product temperature (including edge vials) during annealing should be lower than the melting temperature of the formulation. If product Tg’ is relatively high (e.g., -7 to [...] A 20°C load temperature, 0.5°C/min cooling rate, and a freezing temperature of -45°C are recommended for the freezing cycle. Based on Fig.2, 0.5 h hold time at -45°C would be enough to reach product temperature below -44.8°C. To crystallize mannitol, an annealing temperature of -10°C3 for 3 h is suggested to ensure that crystallization can be efficiently done at the commercial scale. To keep product temperature below Tg’ even for the edge vials during vacuum initiation, re-freezing temperature [...] high (e.g., -7 to -15°C), annealing may not be beneficial. In addition, for aggressive cycles with product T ~ > T collapse, Ostwald ripening of ice crystals can occur during primary drying because of a relatively high product temperature. In such cases, having an additional annealing step may not provide significant benefits in terms of cycle time reduction. It should also be noted that different annealing temperatures can influence the crystallization behavior of the excipients used in the", "position": 5 }, { "title": "Freeze-Drying Protein Formulations above their Collapse Temperatures: Possible Issues and Concerns | American Pharmaceutical Review - The Review of American Pharmaceutical Business & Technology", "url": "https://www.americanpharmaceuticalreview.com/Featured-Articles/37021-Freeze-Drying-Protein-Formulations-above-their-Collapse-Temperatures-Possible-Issues-and-Concerns", "description": "pores where the crystals of pure ice had been. The traditional approach to the design of a lyo cycle is to maintain this completely or partially amorphous phase in a glassy state during primary drying which involves keeping the temperature of the newly freeze-dried material below Tg’, the glass-rubber transition temperature of the amorphous phase which still contains about 20% water. For sucrose-based formulations Tg’ is -34°C to -25°C depending on the protein content Above this temperature [...] In five studies, a broad range of lyophilized protein drug products that included mAb’s and vaccines were subjected to aggressive lyo cycles and exhibited both macro and microcollapse. They were placed on long-term stability at 4 and 25°C with no loss of potency or formation of HMWS species when compared to cakes dried with a conservative lyo cycle [8,15,19-21]. [...] However, it has been demonstrated that there can be a situation, referred to as microcollapse, in which the basic pore structure of the dry layer remains intact even though the product temperature is well above Tg’ during primary drying and the amorphous phase is subject to some viscous flow. If there is loss of the pore structure, that would then be referred to as “macrocollapse” . There are two basic ways of controlling the degree of collapse:", "position": 6 } ], "protein instability during freeze-drying cryoconcentration ice-water interface denaturation": [ { "title": "The Ice-Water Interface and Protein Stability: A Review", "url": "https://www.sciencedirect.com/science/article/abs/pii/S0022354920301817", "description": "## Evidence of Ice Effect on Protein Stability\n\nIt is well known that the freezing process may have detrimental effects for a protein, leading to denaturation, aggregation and loss of biological activity. Numerous phenomena could contribute to the undesired conformational changes of the protein, including cold denaturation, cryo-concentration, or the formation of ice crystals.131,132 [...] for development of stable therapeutic protein products. This review provides an overview of various stress conditions that proteins might encounter during lyophilization process, mechanisms to improve the stability and analytical techniques to tackle the proteins instability during both freeze-drying and storage. [...] behavior at the ice surface may help shed some light on the freezing of biopharmaceuticals, as well. Finally, the relevant variables that influence ice-induced denaturation of proteins, and may help to prevent or modulate it, will be described. Among them, the effect of surfactants, cryoprotectants, protein concentration, cooling/thawing rate and nucleation temperature will be covered.", "position": 1 }, { "title": "Surface-induced denaturation of proteins during freezing ...", "url": "https://pubmed.ncbi.nlm.nih.gov/8961147", "description": "Freeze-induced denaturation of IL-1ra at the ice-water interface during freeze-drying was effectively prevented by adding a small amount of Tween 80.", "position": 2 }, { "title": "Considerations on Protein Stability During Freezing and Its ...", "url": "https://www.jpharmsci.org/article/S0022-3549(19)30659-8/fulltext", "description": "by A Arsiccio · 2020 · Cited by 77 — the ice-water interface is the dominant cause of denaturation for proteins with high bulk stability, while the duration of the freezing process itself", "position": 3 }, { "title": "What's Facing a Protein During Freeze-Drying? - COMSER Pharma", "url": "https://comserpharma.com/whats-facing-a-protein-during-freeze-drying", "description": "During freezing, on account of ice formation, it arises an ice-water or ice-solute interface, both are the same, which is associated with protein denaturation due to ice-protein interactions. Ice crystal size is directly related with the total ice-solute surface, and this size mainly depends on the cooling rate. Faster cooling rates generate more but smaller crystals resulting in a wide ice-solute surface, whereas slower cooling rates generate few but bigger crystals, resulting in a small [...] Although the mechanism of ice-solute surface inducing protein denaturation is not clearly known, several hypotheses have been proposed. It is suggested that the conformational changes of proteins may arise from the direct interaction between the protein and the ice surface (Figure 2.1) Between ice surface and solution a microenvironment which is named Quasi-Liquid Layer (QLL) is formed. Taking this into account, it is proposed that a concentration gradient is formed due to the mobility of the [...] During the freezing step, ice crystals growth leads to freeze-concentrating the solutes of a formulation. This increment serves as a thermodynamic force and causes liquid-liquid phase separation, resulting in the formation of multiple amorphous phases. This may lead to protein instability because of the separation of proteins from the effect of the excipient.\n\n### 5. COLLAPSE", "position": 4 }, { "title": "The Ice-Water Interface and Protein Stability: A Review", "url": "https://www.researchgate.net/publication/340277545_The_Ice-Water_Interface_and_Protein_Stability_A_Review", "description": "The reduction in gel strength showed that the frozen storage progressively weakens the gel formability of FSC due to protein denaturation and loss of cross-", "position": 5 }, { "title": "Effect of Freezing and Thawing Rates on Denaturation of ...", "url": "https://ptacts.uspto.gov/ptacts/public-informations/petitions/1550906/download-documents?artifactId=-DVVpBfD2q7RHDTU1CYBnVAxkYB82X71ALkrNGoMNEDMWiZ19A0x-Ks", "description": "Based on this work, it could be concluded that protein denaturation during freezing, in the absence of protecting chemicals, is mainly caused by surface denaturation and related to exposure to the ice–water interface. It is advisable to use a relatively slow freezing (about 1°C/min) and fast thawing process (>10°C/min). Sodium phosphate buffer and other solutions with a tendency of salt precipitation during freezing should be avoided. An optimal freezing rate may exist that depends on the [...] rate >10°C/min) produced higher activity recovery, whereas fast freezing with slow thawing resulted in more severe damage to proteins. With minimizing the freezing concentration and pH change of buffer solution by using a potassium phos-phate buffer, this phenomenon could be ascribed to sur-face-induced denaturation during freezing and thawing process. Upon the fast freezing (e.g., when the freezing rate >20°C/min), small ice crystals and a relatively large surface area of ice–liquid interface [...] interface are formed, which in-creases the exposure of protein molecules to the ice– liquid interface and hence increases the damage to the proteins. During thawing, additional damage to proteins is caused by recrystallization process. Recrystallization exerts additional interfacial tension or shear on the en-trapped proteins and hence causes additional damage to the latter. When buffer solutes participated during freez-ing, the activity recovery of proteins after freezing and thawing decreased", "position": 6 } ], "Karl Fischer titration residual moisture lyophilized diagnostic reagents specification": [ { "title": "Detecting Residual Moisture in Lyophilized Product", "url": "https://www.pharmtech.com/view/detecting-residual-moisture-lyophilized-product", "description": "Karl Fischer (KF) titration. Measurement of residual moisture in lyophilized products is usually performed using coulometric KF titration, Commercial reagents", "position": 1 }, { "title": "Moisture Analysis in Pharma: Expanding Near-Infrared ...", "url": "https://www.labroots.com/webinar/moisture-analysis-pharma-expanding-near-infrared-spectroscopy", "description": "Karl Fischer titration is the prescribed technique for measuring residual moisture content to monitor process control, sample specification and", "position": 2 }, { "title": "Residual Moisture Content in Lyophilized Drugs", "url": "https://www.lyophilizationworld.com/post/residual-moisture-content-in-lyophilized-drugs", "description": "To determine the residual moisture content then is critical and a number of methods have been used including:\n\n1. Karl Fischer Titration\n2. Thermogravimetric Analysis\n3. Near Infra-red Spectroscopy\n4. Headspace Moisture Analysis [...] 3. Near Infrared Spectroscopy is a method that can be used for nondestructive residual moisture analysis. The basic principle involves shining a beam through the bottom of the vial up into the lyophilized cake. A model can be developed using Karl Fischer as a basis. Once the model is developed, lyophilized vials may be scanned by NIR and the moisture model applied to determine the residual moisture based on peak amplitude. NIR has potential application as a process analytical technology (PAT) [...] 1. The KF method is most widely used and is generally considered to measure the total water within the freeze-dried vial, assuming that the sample is wholly soluble in the KF medium. The KF method is time-consuming, requires operator expertise and careful sample handling to avoid contamination by environmental moisture, and is destructive (meaning that the sample is destroyed during analysis).", "position": 3 }, { "title": "Karl Fischer Titration​ - Precise Moisture Analysis Made Easy | Worldoftest", "url": "https://www.worldoftest.com/articles/karl-fischer-titration", "description": "| Step | Description |\n --- |\n| 1 | Add fresh Karl Fischer reagent to the titration cell. |\n| 2 | Pre-titrate to eliminate residual moisture. |\n| 3 | Maintain a consistent temperature. |\n\n### 3. Running the Analysis [...] When setting up your titration system, you'll need to condition the titration cell by adding fresh reagent and pre-titrating to eliminate residual moisture before sample addition. The titration vessel must be properly sealed and maintained at a consistent temperature to prevent drift and ensure reproducible results. [...] Coulometric Karl Fischer titration generates the titrant electrochemically within the titration cell, providing exceptional sensitivity for trace moisture analysis. This method is capable of measuring water levels as low as 1 ppm, making it ideal for samples with very low water content. The titration cell consists of two compartments: an anodic and a cathodic compartment, with the anodic compartment containing the anolyte solution necessary for the chemical reaction.", "position": 4 }, { "title": "Water Determination by Karl Fischer Titration", "url": "https://www.metrohm.com/content/dam/metrohm/shared/documents/monographs/81085089EN.pdf", "description": "Only volumetrically with combined KF reagents: Bromophenol, catechol, naphthol, hydroxyquinoline, guaiacol, resorcinol, dimethylphe-nol and trimethylphenol.\nFor pyrogallol and the aminophenols the maximum sample weights are 1 g and 0.1 g re-spectively.\n15.4 Esters These normally cause no problems. They can be titrated both coulometrically and volu-metrically. In some cases the addition of a solubility promoter (chloroform or propanol) is recommended to improve the solubility. [...] Formic acid is an exception. In addition to esterification, there is also an iodine oxidation by the KF titrant. This is why reagents for ketones and aldehydes are required. The maxi-mum sample volume is 1 mL as side reactions occur with larger amounts of sample. [...] Of the highly viscous pentanol approx. 1 g is diluted with approx. 10 g methanol and approx. 2 g of the mixture is titrated with the separate KF reagents for aldehydes and ketones.\nFor amoxicillin, penicillin G, dobutamine hydrochloride monohydrate, arginine aspartate and norepinephrine hydrochloride, 30 mL methanol + 5 g salicylic acid is placed in the titration cell and titrated to dryness; the sample is then added and its water content de-termined.", "position": 5 }, { "title": "Karl Fischer Titration – Moisture Analysis", "url": "https://sgsystemsglobal.com/glossary/karl-fischer-titration-moisture-analysis", "description": "Classic KF employs iodine (I2), sulfur dioxide (SO2), a base (to bind SO2 and water), and an alcohol solvent. The commonly cited overall reaction is I2 + SO2 + H2O + 3 base → 2 base·HI + base·HSO4 (in alcohol), though practical formulations use additives and buffering to stabilize kinetics and endpoint sharpness. Modern combi reagents package iodine and SO2 with base in one bottle (volumetric) or in the anolyte/catholyte pair (coulometric). Selectivity is high, but reactive carbonyls [...] to viscous syrups, polymers, lyophilized cakes, and hydrophobic matrices. When executed under ALCOA+ rules with audit trails, KF becomes a high-throughput, inspection-ready moisture platform. [...] Two principal modalities exist. Volumetric KF dispenses a known concentration of iodine reagent to titrate microgram-to-milligram water loads (roughly 0.1%–100% moisture, 1–100 mg H2O). Coulometric KF generates iodine electrochemically in-situ and is ideal for low-level water (typically 1 µg–10 mg, down to single-digit ppm in suitable matrices). Accessories—oven KF with headspace transfer, oils modules, homogenizers, and sample changers—extend KF from powders and granulates to viscous syrups,", "position": 6 } ], "ICH Q1A(R2) stability testing conditions 25C 60RH 30C 65RH 40C 75RH": [ { "title": "ICH Stability Guidelines: Q1A-Q1F Testing Guide May 2026 | Assyro AI", "url": "https://www.assyro.com/blog/ich-stability-guidelines", "description": "ICH Q1A(R2) defines storage conditions for long-term (25C/60% RH), accelerated (40C/75% RH), and intermediate testing\n Photostability testing per ICH Q1B must be performed on at least one batch of drug substance and drug product\n Climatic zones I-IV determine appropriate storage conditions for global market registration per ICH Q1F\n Minimum 12 months long-term stability data is required at the time of regulatory submission [...] ICH stability guidelines Q1A-Q1F provide a harmonized framework: These six guidelines cover stability study design, photostability, reduced testing approaches, data evaluation, and climatic zone considerations for global pharmaceutical registration.\n Standard storage conditions per ICH Q1A are 25C/60% RH long-term and 40C/75% RH accelerated: These conditions support registration in ICH regions (US, EU, Japan). Additional conditions may be needed for hot and humid markets. [...] | Study Type | Storage Condition | Minimum Duration |\n| Long-term | 25C plus or minus 2C / 60% RH plus or minus 5% RH | 12 months |\n| Intermediate | 30C plus or minus 2C / 65% RH plus or minus 5% RH | 6 months |\n| Accelerated | 40C plus or minus 2C / 75% RH plus or minus 5% RH | 6 months |\n\n> “\n>\n> Important: These are minimum requirements. For products intended for sale in Climatic Zones III and IV (hot and humid regions), different long-term conditions apply.", "position": 1 }, { "title": "ICH Q1A(R2) Stability Guidelines | ARE Labs", "url": "https://www.arelabs.com/information/regulatory/ich-q1a", "description": "| Case | Long-term frame | Accelerated or additional frame |\n --- \n| General drug substance or drug product | 25C +/- 2C / 60% RH +/- 5% RH or 30C +/- 2C / 65% RH +/- 5% RH, with 12 months of data at submission | 40C +/- 2C / 75% RH +/- 5% RH for 6 months; intermediate 30C / 65% RH when triggered |\n| Semi-permeable container | Lower-RH long-term condition, such as 25C / 40% RH or 30C / 35% RH | Low-RH accelerated condition to evaluate water loss, with product-specific justification | [...] | Refrigerated drug product | 5C +/- 3C, with 12 months of data at submission | 25C +/- 2C / 60% RH +/- 5% RH for 6 months |\n| Frozen drug product | -20C +/- 5C, with 12 months of data at submission | Shelf life is based on real-time data at the long-term storage condition | [...] | Storage condition and duration | Covers storage, shipment, and subsequent use under justified conditions | Chamber assignment, temperature/RH targets, pulls, and excursions |\n| Stability-indicating methods | Evaluates attributes likely to affect quality, safety, or efficacy | Method validation status, acceptance criteria, and raw endpoint data |", "position": 2 }, { "title": "ICH Stability Testing | Packaging Compliance Labs", "url": "https://pkgcompliance.com/test/ich-stability-testing", "description": "Storage conditions are to be 25C/60%RH or 30C/65%RH or 30C/75%RH\n\nIntermediate Duration Stability testing – Minimum aging duration of 6 months\n\n Storage condition is to be 30C/65%RH or 30C/75%RH\n\nAccelerated Stability testing – Minium duration of 6 months\n\n Storage condition is to be 40C/75%RH\n\nNormal tolerance variables ranges are +/- 2C /5% RH.\n\nRequest A Quote\n\n### ICH Stability Types for Refrigerated/Frozen Products\n\nA client with Refrigerated product could elect to do: [...] Long Term Stability testing – Minimum aging duration of 12 months\n\n Storage conditions are to be 5C (+/- 3C)\n\nAccelerated Stability testing – Minium duration of 6 months\n\n Storage condition is to be 25C/60%RH or 30C/65%RH or 30C/75%RH ( +/- 2C /5% RH).\n\nA client with Frozen product could elect to do:\n\nLong Term Stability testing – Minium duration of 12 months\n\n Storage condition is to be -20C (with a +/- of 5C)\n\nAccelerated Stability Testing [...] As there is no Accelerated storage condition for frozen product, ICH recommends testing a single batch at an elevated temperature (5C or 25C) to simulate short term excursion.\n\nRequest A Quote\n\n## ICH Stability Testing\n\nComplete the form below and one of our packaging experts will reach out to for more information!\n\n### ICH Zones and Associated Conditions\n\nChecklist Icon\n\nZone I (Temperate) – 21C/45%RH\n\nChecklist Icon\n\nZone II (Subtropical/Mediterranean) – 25C/60%RH\n\nChecklist Icon", "position": 3 }, { "title": "ICH Q1A(R2) Stability Testing: Key Concepts and Conditions", "url": "https://quizlet.com/study-guides/ich-q1a-r2-stability-testing-key-concepts-and-conditions-992df4cf-4235-4a8a-9e26-8b26afffba7f", "description": "Long-term storage conditions for drug products mirror those for drug substances, typically at 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5", "position": 4 }, { "title": "Q1A(R2) Guideline", "url": "https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf", "description": "conditions can be used, if justified. 2.2.7.1. General case Study Storage condition Minimum time period covered by data at submission Long term 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH 12 months Intermediate 30°C ± 2°C/65% RH ± 5% RH 6 months Accelerated 40°C ± 2°C/75% RH ± 5% RH 6 months It is up to the applicant to decide whether long term stability studies are performed at 25  2°C/60% RH  5% RH or 30°C  2°C/65% RH  5% RH. Stability Testing of New Drug Substances and [...] ± 2°C/60% RH ± 5% RH to 30°C ± 2°C/65% RH ± 5% RH can be appropriate provided that the respective storage conditions and the date of the switch are clearly documented and stated in the registration application. It is recommended that registration applications contain data from complete studies at the intermediate storage condition 30°C ± 2°C/65% RH ± 5% RH, if applicable, by three years after the date of publication of this revised guideline in the respective ICH tripartite region. i STABILITY [...] storage condition has been changed from 30°C ± 2°C/60% RH ± 5% RH to 30°C ± 2°C/65% RH ± 5% RH in the following sections:  2.1.7.1 Drug Substance - Storage Conditions - General Case  2.2.7.1 Drug Product - Storage Conditions - General Case  2.2.7.3 Drug products packaged in semi-permeable containers  3 Glossary - “Intermediate testing” 2. 30°C ± 2°C/65% RH ± 5% RH can be a suitable alternative long-term storage condition to 25°C ± 2°C/60% RH ± 5% in the following sections:  2.1.7.1 Drug", "position": 5 }, { "title": "Stability tests with BINDER products", "url": "https://www.binder-world.com/us-en/applications/environmental-simulation/stability-testing", "description": "Sample preparation: Drug batches are selected, prepared for analysis and labeled.\n Determination of test conditions: The storage conditions are defined in accordance with the ICH guidelines. Typical storage conditions are as follows:\n + Long-term stability tests at 25°C and 60% r.h.\n + Accelerated stability tests at 40°C and 75% r.h.\n + Intermediate tests at 30°C and 65% r.h. [...] The stability tests are carried out in special climate chambers, which serve as precision-controlled environments for storage of drug samples. These climate chambers enable precise control and monitoring of temperature, relative humidity and, if necessary, other ambient parameters such as light intensity. The homogeneity of the climate parameters, temperature and humidity is absolutely crucial, and safe and reliable continuous operation of the climate chamber is essential if ICH stability [...] Temperature range: +10°C to +50°C \nHumidity range: 20% r.h. to 90% r.h. \nSizes: 12 to 24 cubic meters in volume\n\n To the walk-in chambers\n\n## Documentation of ICH stability testing\n\nIt is essential that the framework conditions and the interpretation of the results are fully and comprehensibly documented in order to meet the regulatory requirements. As a result, the documentation requirements are stringent.", "position": 6 } ], "翌圣 Yeasen 可冻干 RT-qPCR 预混试剂": [ { "title": "精品推荐|可冻干的RT-qPCR预混试剂！", "url": "https://www.yeasen.com/h5/solutiondetail/1948567459457175552", "description": "一种无甘油、即用型的分子诊断试剂，含有RT-qPCR反应所需的所有组分以及冻干保护剂，使用 UDG-dUTP 防污染体系，能有效防止扩增产物气溶胶污染的风险。此外，提供参考冻干工艺、兼容多种冻干形式，既可作为常规液体PCR体系的开发原料，亦可作为冻干PCR体系的开发原料。\n\n产品优势\n\n 冻干后依然保持酶活性完整，性能和液体试剂一样；\n 采用基因改造的抗体法热启动 Taq 酶，灵敏度高，5 copies/T可稳定检出；\n 含引物探针的冻干球，在50℃热加速33天，性能不受影响；\n\n01\n\n结果：16645适用于原位冻干及冻干球冻干，原位冻干时冻干品处于管底部，且无塌陷；冻干球外观洁白光滑有光泽，无明显发黄、坍塌和收缩，且复溶迅速。\n\n02 [...] 翌圣生物提供优质可冻干原料—\n\n让核酸检测更加高效、便捷、经济\n\n冻干原料的筛选不是单纯去掉不可冻干物质，原料选择环节需要针对每一个组份进行筛选或调试。翌圣生物Zyme Editor™酶改造平台通过理性设计和定向进化获取性能优异的酶原料，再结合储液优化、反应buffer调试、冻干保护剂的筛选及组合测试、冻干参数的测定等，实现冻干产品性能不差于常规液体PCR试剂、冻干成品形态完整、储存稳定的RT-qPCR可冻干试剂。\n\n \n\n冻干是通过冷冻干燥的方法将液体中的水分移除，是一个多步骤的过程。冷冻干燥主要包括预冻、退火、一次干燥和二次干燥等关键阶段。精确调控每个步骤的条件及参数，对于确保酶制剂在冻干后的生物活性和稳定性至关重要，这其中预冻阶段的冻结温度、一次干燥阶段的崩解温度和加热速率和二次干燥阶段的温度和时间尤为重要。\n\n表1. 冻干各个环节中的影响因素 [...] 针头式过滤器\n\n通用辅助耗材\n\n微孔过滤板/过滤柱\n\n首页 产品解读 应用详情\n\n精品推荐 | 可冻干的RT-qPCR预混试剂！\n\n12281\n\n2025-07-25\n\n分享\n\n收藏\n\n在分子检测领域，技术的革新与产品的优化始终是推动行业发展的关键力量。早期国内冻干技术多用于制药领域，分子诊断试剂冻干发展相对缓慢，PCR冻干试剂是指将PCR反应所需的各种组分（包括DNA聚合酶、逆转录酶、dNTPs、MgCl2、缓冲液和引物等）进行冻干处理，制备成稳定的粉末状/冻干球制品。加水复溶后，即可直接进行PCR反应。与传统的液态PCR试剂相比，冻干试剂稳定性强，便携性、易用性高且可适配自动化设备，大大拓展了PCR技术在病原体快速诊断、基因检测、法医鉴定等领域真实场景的应用范围。\n\n \n\n随着政策鼓励医疗资源下沉，持续推进基层卫生工作，以及针对发展中国家和资源匮乏地区，尤其是广阔海外市场的拓展，PCR冻干试剂的应用范围也将进一步扩大，它的运输稳定性和成本优势将发挥更大的作用，为疾病防控和公共卫生事业做出重要贡献。\n\n \n\n翌圣生物提供优质可冻干原料—", "position": 1 }, { "title": "翌圣高品质可冻干PCR原料及预混液，高性能、商业供应稳定", "url": "https://pierre.bioon.com.cn/article/5c802924581a", "description": "2）以人源RNA病毒为模板，使用Yeasen 可冻干RT-qPCR预混液（Cat#13775ES），进行冻干前后多重体系扩增测试。结果显示：冻干前后Ct值和荧光值均无显著变化", "position": 2 }, { "title": "翌圣高品质可冻干PCR原料及预混液，高性能、商业供应稳定", "url": "https://www.yeasen.com/h5/solutiondetail/1151", "description": "产品优势. 预混冻干保护剂，操作简便稳定性好：液体试剂37℃可稳定放置7天、冻干试剂可常温储存冻干形态多样：八连管原位冻干、西林瓶冻干饼、冻干球、冻干微芯等. /.", "position": 3 }, { "title": "精品推荐| 可冻干的RT-qPCR预混试剂！-企业动态", "url": "https://www.biomart.cn/news/16/3242043.htm", "description": "精品推荐| 可冻干的RT-qPCR预混试剂！ · 冻干后依然保持酶活性完整，性能和液体试剂一样； · 采用基因改造的抗体法热启动Taq 酶，灵敏度高，5 copies/T可", "position": 4 }, { "title": "通用型高灵敏一步RT-qPCR试剂，省时高效！", "url": "https://www.yeasen.com/h5/solutiondetail/3446", "description": "产品中心\n 产品应用\n 支持中心 \n\n + 文献中心\n + FAQ中心\n + COA下载\n + 下载中心\n + 视频管理\n + 线上工具\n 新闻资讯\n 活动专区 \n\n + 产品活动\n + 试用中心\n + 积分商城\n 关于我们 \n\n + 公司介绍\n + 加入我们\n + 联系我们\n + 创新平台\n\n分子生物学\n\nPCR\n\nqPCR\n\n逆转录试剂\n\n分子克隆\n\n快速T4 DNA连接酶\n\n核酸电泳\n\nDNA Marker\n\n核酸提取与纯化\n\nIVD分子诊断\n\nqPCR预混液\n\nRT-qPCR预混液\n\n可冻干预混液\n\nPCR分子酶原料\n\n恒温扩增LAMP原料\n\nBst DNA聚合酶\n\n恒温扩增RPA原料\n\n半成品试剂盒\n\n细胞培养与分析\n\n细胞培养\n\n细胞分选\n\n细胞检测与分析\n\n亚细胞研究\n\n动物模型构建\n\n外泌体研究\n\n类器官培养\n\n蛋白研究\n\n蛋白酶\n\n蛋白纯化\n\n离子交换层析\n\n疏水层析\n\n凝胶过滤层析\n\n磁珠系列\n\n层析相关试剂\n\n层析耗材\n\n无细胞蛋白表达系统\n\n免疫印迹/Western Blot\n\n蛋白抽提\n\n蛋白定量\n\n蛋白电泳\n\n转膜、封闭与对照 [...] 产品性能展示\n\n全仪器平台通用\n\n| | | |\n --- \n| No Rox平台 | Low Rox平台 | High Rox平台 |\n\n图.以293T细胞总RNA作为模板，分别在不同ROX类型机型上扩增不同GC含量的靶标。结果显示均可有效扩增，且熔解峰单一。\n\n灵敏度高\n\nRNA模板检测\n\n图.以RNA模板进行测试时，对于高表达的靶标，可以检测到0.1pg级别，中等表达的靶标，可以检测到1pg级别；病毒类可以检测到E2。\n\nDNA模板检测\n\n图.以DNA样本进行测试时，可轻松检测十位数拷贝以上的基因。另外针对以上样本的单拷贝检测，也可出现扩增信号。\n\n灵敏度性能比对\n\n图.分别以人293T细胞、HCV、新冠假病毒、拟南芥来源的RNA作为模板在不同的仪器上进行测试，结果显示，相较于进口品牌，翌圣的11175ES的灵敏度更好，荧光平台期更高。\n\n精准度好\n\n图.以293T细胞RNA为模板，2倍形式梯度稀释模板，以11175ES进行检测。结果显示，11175ES可以精确分辨2倍的浓度模板差异。\n\n稳定性好 [...] [[16936ES]\n\nHifair® I Multiplex One Step RT-qPCR Lyophilized Microsphere RT-qPCR八联排冻干微芯（16645冻干版本）](/products/detail/1981264328563175425)\n\n[[11899ES]\n\nHifair® Superpro Ⅱ One Step RT-qPCR Master Mix 一代通用、全预混RT-qPCR预混液](/products/detail/13182)\n\n[[16913ES]\n\nHifair® Superpro Fast One Step RT-qPCR Master Mix (UDG Plus) 二代快速、全预混RT-qPCR预混液](/products/detail/1907598932504772609)\n\n[[16994ES]\n\nHieff® Fast Cells Lysis Kit V2 细胞直接裂解液](/products/detail/2093267345662328835)\n\n[[16630ES]", "position": 5 }, { "title": "Lyo qPCR & RT-qPCR", "url": "https://www.yeasenbio.com/collections/lyo-qpcr-rt-qpcr-kit", "description": "# Lyo qPCR & RT-qPCR\n\n5 products\n\nShowing 1 - 5 of 5 products\n\nYeasen offers lyophilizable reagents for enhanced in vitro diagnostics. Our portfolio includes two Lyo-ready One-step RT-qPCR Kits for RNA detection—one standard and one advanced with UDG enzyme for contamination control. Additionally, our DNA detection reagent, formulated with lyophilization protectants and dNTPs, ensures superior amplification stability and multiplex capabilities for robust molecular diagnostics. [...] Skip to content\n\nYEASEN - Leading Innovation in Molecular Enzymes and Reagents. Cleaner, Faster, Safer and Higher Efficiency.\n\nYeasen - Leading Innovation in Molecular Enzymes and Reagents Yeasen - Leading Innovation in Molecular Enzymes and Reagents\n\nLogin / Signup\n\nMy account\n\n0\n\nCart\n\nUse this bar to show information about your cookie policy.\n\nProduct Categories [...] Yeasen Hifair™ Lyo-Ready Robust Multiplex One Step RT-qPCR Kit（UDG plus) \\_ 16943ES\n\nSale price $165.00\n\nLyoprotectant V2 _ 13743ES\n\nYeasen Lyoprotectant V2 \\_ 13743ES\n\nSale price $35.00\n\nHieff Unicon™ Lyo-Ready I TaqMan Multiplex qPCR Mix -11893ES\n\nYeasen Hieff Unicon™ Lyo-Ready I TaqMan Multiplex qPCR Mix -11893ES\n\nSale price $135.00\n\nFilters (0)\n\n## Inquiry\n\n## Most Viewed Products\n\nShipping", "position": 6 } ], "诺唯赞 Vazyme 冻干 qPCR 试剂盒": [ { "title": "南京诺唯赞生物科技股份有限公司", "url": "https://bio.vazyme.com/products/76.html", "description": "- 逆转录\n - qPCR\n - 一步法RT-qPCR\n - 一步法RT-PCR\n - 冻干试剂\n - 等温扩增\n - PCR仪\n - 自动化核酸提取仪\n - 自动化移液工作站\n - 动物疫病诊断\n - 实时荧光定量PCR仪\n - 化学发光设备\n - 核酸提取系列\n - DNA建库系列\n - RNA建库系列\n - 多重扩增系列\n - DNA&RNA共建库系列\n - 分子实验耗材\n - 设备配套耗材\n - 细胞培养耗材\n - 分子原料\n - 免疫原料\n - 细胞蛋白原料\n - 生物微球\n - 哺乳动物表达系统\n - 标志物检测试剂盒\n - 化学发光设备\n - 化学发光设备耗材 [...] DNA建库系列 RNA建库系列 多重扩增系列 表观遗传系列 单细胞系列 三代建库系列 杂交捕获系列 DNA&RNA共建库系列 磁珠系列 定量系列 接头系列 环化&转化试剂 自动化移液工作站 NGS自动化\n\n PCR 逆转录 qPCR 一步法RT-qPCR 一步法RT-PCR 冻干试剂 等温扩增 PCR仪\n\n 自动化核酸提取仪 自动化移液工作站 动物疫病诊断 实时荧光定量PCR仪 化学发光设备\n\n 核酸提取系列 DNA建库系列 RNA建库系列 多重扩增系列 DNA&RNA共建库系列\n\n 分子实验耗材 设备配套耗材 细胞培养耗材\n\n 分子原料 免疫原料 细胞蛋白原料 生物微球 哺乳动物表达系统\n\n 标志物检测试剂盒 化学发光设备 化学发光设备耗材\n\n 高保真PCR 快速PCR 普通PCR 高产量PCR 长片段PCR 热启动PCR 直接扩增PCR PCR相关 [...] - 探针法qPCR预混液\n - 甲基化qPCR专用试剂\n + 一步法RT-qPCR\n\n - 两管式预混液\n - 一管式预混液\n + 一步法RT-PCR\n\n - 两管式预混液\n - 一管式预混液\n + 冻干试剂\n\n - RT酶\n - RNA酶抑制剂\n - Bst酶\n - Taq酶\n - 一步法RT-qPCR预混液\n + 等温扩增\n\n - RT酶\n - Bst酶\n - RT-LAMP专用预混液\n - LAMP荧光染料\n + PCR仪\n\n - 实时荧光定量PCR仪\n 仪器设备\n\n + 自动化核酸提取仪\n + 自动化移液工作站\n + 动物疫病诊断\n + 实时荧光定量PCR仪\n + 化学发光设备\n 病原检测UltraClean系列\n\n + 核酸提取系列\n\n - DNA提取\n - DNA/RNA共提取\n + DNA建库系列\n\n - 片段化酶法DNA建库\n + RNA建库系列", "position": 1 }, { "title": "南京诺唯赞生物科技股份有限公司", "url": "https://bio.vazyme.com/products/18.html", "description": "逆转录预混液（qPCR专用） 通用型逆转录试剂（PCR/qPCR） 逆转录单酶 miRNA逆转录专用试剂盒 5’RACE & 3’RACE扩增 病原多重检测专用逆转录 单细胞预扩增", "position": 2 }, { "title": "产品中心 - 南京诺唯赞生物科技股份有限公司", "url": "https://bio.vazyme.com/products_26/265.html", "description": "逆转录预混液（qPCR专用） 通用型逆转录试剂（PCR/qPCR） 逆转录单酶 miRNA逆转录专用试剂盒 5’RACE & 3’RACE扩增 病原多重检测专用逆转录 单细胞预扩增", "position": 3 }, { "title": "PCR - 南京诺唯赞生物科技股份有限公司", "url": "https://bio.vazyme.com/products_4/89.html", "description": "逆转录预混液（qPCR专用） 通用型逆转录试剂（PCR/qPCR） 逆转录单酶 miRNA逆转录专用试剂盒 5’RACE & 3’RACE扩增 病原多重检测专用逆转录 单细胞预扩增", "position": 4 }, { "title": "核酸提取与纯化-产品中心-南京诺唯赞生物科技股份有限公司", "url": "https://bio.vazyme.com/products_3/2.html", "description": "逆转录预混液（qPCR专用） 通用型逆转录试剂（PCR/qPCR） 逆转录单酶 miRNA逆转录专用试剂盒 5’RACE & 3’RACE扩增 病原多重检测专用逆转录 单细胞预扩增", "position": 5 }, { "title": "分子生物学-qPCR系列_南京诺唯赞生物科技股份有限公司", "url": "https://bio.vazyme.com/products_64.html", "description": "逆转录预混液（qPCR专用） 通用型逆转录试剂（PCR/qPCR） 逆转录单酶 miRNA逆转录专用试剂盒 5’RACE & 3’RACE扩增 病原多重检测专用逆转录 单细胞预扩增", "position": 6 } ], "纽哈勃 NHID 冻干 PCR 试剂盒": [ { "title": "NHID® 43Y案件试剂盒（冻干）_法医DNA试剂_PCR酶原料_分子诊断整体解决方案提供商-新海生物_苏州新海生物", "url": "http://www.nuhighbio.com/proshow_52.html", "description": "### 样品采集及处理\n\n ### 经典NACC卡（等同FTA卡）\n ### 503采血卡\n ### 样品简易处理液\n\n### 耗材系列\n\n ### 光学贴膜\n ### 核酸清除剂\n\nNHID® Captain Y-STR试剂盒（冻干版）\n\n产品描述 产品特性 产品参数试用装申请\n\n产品描述\n\nNHID®Captain Y-STR冻干版具备与液体版NHID®Captain Y-STR完全一致的位点排列和灵敏度及抗抑制能力。NHID®Captain Y-STR冻干版为独立盖八连管原位冻干，支持最大10μL全体积加入提取的DNA样本，与液体版相比，样本加入量从70%提升至100%，进一步提升了微量男性样本的检出率。\n\n产品特性\n\n高品质试剂盒\n\n大体积加样：支持最大100%体积加入样本，高于市面常见Y-STR试剂盒；\n\n混合样本：对于1:8的男男混合样本，微量样本检出率为100%；对于1:2000的男女混合样本，男性检出率为100%，且无女性非特异扩增峰检出； [...] 降解样本：含有14个扩增片段小于250bp的mini-STR基因座，符合GB/T 41009-2021推荐的20个A类（核心）基因座均在350bp以内，利于高度降解等疑难检材的分型和比对；\n\n八连管定量分装：预分装试剂，即拆即用；\n\n卓越稳定的冻干技术：支持常温储运，无论是温度或湿度变化，均不会对试剂盒的性能产生显著影响，从而确保检测结果的准确性和均一性；\n\n防污染：仅需1次开盖，大大降低开盖导致气溶胶污染的可能性；\n\n无损耗：无试剂配比及使用损耗；\n\n快速扩增：PCR扩增时间小于70min；\n\n国际专利适配体酶：Mix预混酶体系可室温长期放置；“断电”保护，可逆热启动，任一阶段断电均可直接继续扩增；\n\n自主发明内部质控：内含专利内质控【ZL201010605791.2】，监控PCR过程并有效区分样本降解或抑制。\n\n高品质试剂盒\n\n兼容性好：兼容了目前市面上主流Y-STR试剂盒的基因座，涵盖：公安部20个核心位点、15个优选基因座、5个备选基因座、3个 Y-indel基因座\n\n图1：NHID® Captain Y-STR试剂盒基因座排布图，所有基因座的扩增片段范围65-520bp [...] 高品质试剂盒\n\n灵敏度与液体版一致\n\n※ProFlex™ 96-Well PCR System；29cycles ；9948标准DNA重复100次试验 \n \n抑制水平与液体版一致\n\n对于含有腐殖酸、血红素、靛蓝、氯化钙、胶原蛋白的0.125ng的微量样本，抗抑制水平表现更优秀。\n\n混合样本检测\n\n对于模板量1:8的男男混合样本，微量样本检出率为100%； \n对于模板量1:2000的男女混合样本，男性样本检出率为100%，且无女性非特异扩增峰检出。\n\n产品参数\n\n| | | |\n --- \n| 产品名称 | 货号 | 规格 |\n| NHID® Captain Y-STR试剂盒（冻干版） | NH9629 | 200人份；48人份 |\n\n试用装申请", "position": 1 }, { "title": "【人民日报健康】国内首款冻干型新冠核酸检测试剂盒获批", "url": "https://www.capitalbio.com/news/256.html", "description": "这款试剂盒由博奥晶典研发,基于RT-PCR技术,将扩增反应所用的缓冲液、酶、引物、探针混合到冻干微球中,采用96孔板或八连排管预装冻干微球", "position": 2 }, { "title": "新冠核酸检测原料解决方案：快速、可冻干", "url": "https://www.yeasen.com/h5/solutiondetail/763", "description": "一种无甘油、即用型的分子诊断试剂，含有耐热逆转录酶、热启动Taq DNA聚合酶、反应缓冲液、dNTPs、氯化镁以及冻干保护剂，同时添加了有效抑制非特异性PCR扩增的因子和提升", "position": 3 }, { "title": "刘博谈| 如何对新冠PCR诊断试剂盒进行冷冻干燥", "url": "https://zhuanlan.zhihu.com/p/548606499", "description": "冻干的PCR试剂盒母液是预先配制好的,在这种情况下试剂盒不仅包含所有需要的成分,你还能提高你的效率和一致性,避免污染,并且消除移液错误", "position": 4 }, { "title": "NEB® PCR 克隆试剂盒", "url": "https://www.neb.cn/zh-cn/products/e1202-neb-pcr-cloning-kit", "description": "该线性载体利用独特的机制抑制背景菌落生长，使背景值降为最低。本试剂盒能简单、快速克隆各种PCR 产物，包括具有校读功能的聚合酶产生的平末端扩增子（如：Q5®）和无校对", "position": 5 }, { "title": "PCR 试剂和试剂盒", "url": "https://www.sigmaaldrich.com/HK/zh/products/molecular-biology-and-functional-genomics/pcr-and-amplification/pcr-reagents-and-kits", "description": "我们为PCR 工作流程中的各种PCR、qPCR 和RT-PCR 应用提供专用试剂盒。此外，请浏览我们提供的与PCR 相关的全面资源，包括标准PCR 协议和PCR 主混合物计算器工具。为了实现", "position": 6 } ], "Meridian Bioscience lyophilizable PCR master mix glycerol free air dryable": [ { "title": "Lyophilized & Air-Dryable PCR Master Mixes", "url": "https://www.meridianbioscience.com/lifescience/products/molecular-reagents/lyo-ready-air-dryable-master-mixes-reagents", "description": "Meridian offers general and sample specific master mixes and glycerol-free enzymes and buffers for the preparation of both lyophilization and air-drying of", "position": 1 }, { "title": "Air-dryable master mixes replace lyophilization in the ...", "url": "https://www.pharmaceuticalprocessingworld.com/air-dryable-master-mixes-replace-lyophilization-in-the-manufacturing-of-molecular-assays", "description": "Meridian's R&D team explored the possibility of a glycerol-free polymerase that includes a buffer containing specialized excipients to preserve", "position": 2 }, { "title": "Master Mixes for Molecular Ambient-Temperature Stable ...", "url": "https://www.meridianbioscience.com/uploads/Meridian-Master-Mixes-for-Molecular-Ambient-Temperature-Stable-Assays-1.pdf", "description": "VOLUME REACTIONS Air-Dryable™ 1-Step RT-qPCR Mix, 4x MDX095 5 mL 1,000 Rxn 50 mL 10,000 Rxn www.meridianlifescience.com Air-Dryable™ Direct DNA qPCR Blood • \u0007 Glycerol-free mix containing Taq polymerase, reaction buffer, dNTPs, MgCl2, and air-dry excipients • \u0007 Specifically designed to overcome PCR inhibitors found in whole blood, plasma and serum • \u0007 Ideal for developing direct (extraction-free) qPCR assays that are ambient-temperature stable PRODUCT HIGHLIGHTS PRODUCT CAT NO. [...] +1 800 327 6299 Email: info@meridianlifescience.com Orders: orders@meridianlifescience.com www.MeridianLifeScience.com To test a sample or to ask additional questions, E: info@meridianlifescience.com PRODUCT HIGHLIGHTS Comparison of freshly prepared and lyophilized glycerol-free Taq HS master mixes A 10-fold serial dilution of template DNA was used to set up two sets of qPCR assays. One set was lyophilized (blue) and the other left as a wet mix (black). Results illustrate that lyophilization of [...] conditions) HOW IT WORKS Air-Dryable Air-Dryable™ qPCR Mix • \u0007 Simple and easy to use glycerol-free mix containing Taq polymerase, reaction buffer, dNTPs, MgCl2, and air-dry excipients • \u0007 Ideal for multiplex assays on POC diagnostic platforms or automated high-throughput instruments • \u0007 Compatible with a range of air-drying protocols to produce an ambient temperature stable mix • \u0007 Reduces cost and complexity Air-Dryable™ RT-qPCR Mix • \u0007 Simple and easy to use • \u0007 Ideal for multiplex assays on", "position": 3 }, { "title": "RT-PCR/RT-qPCR Master Mixes", "url": "https://www.meridianbioscience.com/lifescience/products/molecular/rt-pcr-rt-qpcr-master-mixes", "description": "Removing the glycerol allows give assay developers the option for compatibility with lyophilization or air-drying, to dry down for stable ambient temperature", "position": 4 }, { "title": "Glycerol-Free Taq HS High Conc. DNA Polymerase", "url": "https://www.meridianbioscience.com/lifescience/products/molecular/glycerol-free-taq-hs-high-conc-dna-polymerase", "description": "Meridian's robust, high concentrated, glycerol-free DNA polymerase, ideal for bulk manufacturing of amplification mixtures for subsequent lyophilization.", "position": 5 }, { "title": "Aptamer Taq HS (Glycerol-Free)", "url": "https://www.meridianbioscience.com/lifescience/products/molecular/aptamer-taq-hs-glycerol-free", "description": "The glycerol-free formulation can be used to produce lyophilized or air-dried, ambient-temperature stable PCR or qPCR reagents and exhibit the same high", "position": 6 } ], "Thermo Fisher lyophilized qPCR master mix": [ { "title": "Thermo Fisher Introduces TaqMan qPCR Master Mixes | American Laboratory", "url": "https://www.americanlaboratory.com/594805-Thermo-Fisher-Introduces-TaqMan-qPCR-Master-Mixes", "description": "“The lyophilization phase can be a challenging part of any workflow to navigate, even for those with experience,” said Kathy Latham, Senior Director, qPCR Reagents at Thermo Fisher Scientific. “Our Lyo-Ready Master Mixes take the guess work out of choosing an excipient and provide consistent performance. Taken together, we believe this will help our customers shorten the path from an idea to a commercial lyophilized product.” [...] Applied Biosystems has introduced the TaqMan™ 2.5X Lyo-Ready 1-step qPCR Master Mix with excipient, an optimized, ready-to-use formulation to be incorporated into a lyophilization process. All lots are functionally tested to help ensure lot-to-lot reproducibility. This reagent is manufactured in an ISO 13485-certified facility to a high level of quality standards. Lyophilization guidelines provided together with the product will help to ensure a fast and reliable switch from liquid to [...] American Laboratory\nIndonesia\n\n# Thermo Fisher Introduces TaqMan qPCR Master Mixes\n\n Thermo Fisher Introduces TaqMan qPCR Master Mixes\n\nCARLSBAD, Calif. (February 21, 2023) – New qPCR master mixes, optimized for use in lyophilization, may help to shorten the path from discovery to commercialization of final assay.", "position": 1 }, { "title": "Thermo Scientific PCR Master Mix (2X) 200 Reactions | Buy Online | Thermo Scientific™ | Fisher Scientific", "url": "https://www.fishersci.pt/shop/products/pcr-master-mix-2x/11853913", "description": "Thermo Scientific PCR Master Mix is a 2X concentrated solution of Taq DNA Polymerase, dNTPs, and all of the components required for PCR, except DNA template and primers. This pre-mixed formulation saves time and reduces contamination due to a reduced number of pipetting steps required for PCR set up. The mix is optimized for efficient and reproducible PCR.\n\nHighlights [...] ## Description\n\nThermo Scientific PCR Master Mix is a 2X concentrated solution of Taq DNA Polymerase, dNTPs, and all of the components required for PCR, except DNA template and primers. [...] | | |\n --- |\n| Concentration | 2X |\n| Content And Storage | • 2X PCR Master Mix, 4 x 1.25 mL • Nuclease-free water, 4 x 1.25 mL Store at -20°C. |\n| GC-Rich PCR Performance | Low |\n| Polymerase | Taq DNA Polymerase |\n| Reaction Speed | Standard |\n| Product Type | PCR Master Mix |\n| Quantity | 200 reactions |\n| For Use With (Application) | Standard PCR |\n| Fidelity (vs. Taq) | 1X |\n| Hot Start | No |\n| No. of Reactions | 200 Reactions |\n| Overhang | 3'-A |", "position": 2 }, { "title": "Real Time PCR Master Mixes | Thermo Fisher Scientific", "url": "https://www.thermofisher.com/search/browse/category/us/en/90217032", "description": "Compare\n\nMaxima SYBR Green/ROX qPCR Master Mix (2X)\n\nMaxima SYBR Green/ROX qPCR Master Mix (2X)\n\nThe master mixes include Maxima Hot Start Taq DNA Polymerase and dNTPs in an optimized PCR buffer. Only template and primers need to be added. The SYBR Green I intercalating dye allows for DNA detection and analysis without using sequence-specific probes.\n\nCompare\n\nPowerUp™ SYBR™ Green Master Mix for qPCR\n\nPowerUp™ SYBR™ Green Master Mix for qPCR [...] PowerUp™ SYBR™ Green Master Mix is a pre-formulated, optimized, universal 2X master mix for real-time PCR workflows. Coupled with user-supplied primer sets and template, PowerUp™ SYBR™ Green Master Mix is designed to amplify targets for accurate gene expression analysis.\n\nCompare\n\nDyNAmo ColorFlash SYBR Green qPCR Kit\n\nDyNAmo ColorFlash SYBR Green qPCR Kit [...] The 2X master mix contains a blue dye, and a separate sample buffer contains a yellow dye. The qPCR reaction mix containing both components is green. Using this patent-pending multicolor system, pipetting of both the master mix and the sample can be easily monitored.\n\nCompare\n\nTaqMan™ Environmental Master Mix 2.0\n\nTaqMan™ Environmental Master Mix 2.0\n\nAccurate, real-time PCR-based pathogen detection in the presence of high levels of inhibitors.\n\nCompare", "position": 3 }, { "title": "TaqMan Lyo-Ready qPCR Master Mixes", "url": "https://www.thermofisher.com/us/en/home/life-science/pcr/real-time-pcr/real-time-pcr-reagents/taqman-real-time-master-mixes/lyo-ready.html", "description": "Download 1-Step Brochure Request a quote\n\nDownload qPCR Brochure Request a demo\n\nDownload Lyo Ready Whitepaper\n\nTaqMan Lyo-Ready qPCR master mixes are available in several formulations. Customization is also available and can be requested by contacting your Thermo Fisher Scientific representative or emailing custom.solutions@thermofisher.com.\n\n## Which TaqMan Lyo-Ready master mix is right for your application? [...] Reliable and storage-temperature-agnostic molecular diagnostics qPCR assays need to utilize reagents that are easily lyophilized and provide consistent performance even with non-ideal samples. TaqMan Lyo-Ready qPCR master mixes fulfill these requirements, making them highly suited to lyophilized qPCR assays using your chosen primers and probes. [...] TaqMan Lyo-Ready qPCR master mixes are designed for consistent performance even in demanding applications, including virus and bacteria detection. Easy to lyophilize and fast to re-hydrate, they ensure consistency before and after lyophilization even in multiplex reactions.", "position": 4 }, { "title": "TaqMan™ Lyo-ready 1-Step RT-qPCR Master Mix", "url": "https://documents.thermofisher.com/TFS-Assets/LSG/manuals/MAN0018866_TaqManLyo-ready1-Step%20RT-qPCRMasterMix_QR.pdf", "description": "The master mix is designed to be incorporated into a lyophilization process. In most lyophilization processes, additional excipients will be required.", "position": 5 }, { "title": "TaqMan™ 2.5X Lyo-Ready 1-step qPCR Master Mix, with ...", "url": "https://www.thermofisher.com/order/catalog/product/C14031B001", "description": "TaqMan™ 2.5X Lyo-Ready 1-step qPCR Master Mix, with excipient. TaqMan Lyo-Ready qPCR Master Mixes - a fast-track to lyophilized solution.", "position": 6 } ], "NEB LyoPrime lyophilized PCR master mix": [ { "title": "New England Biolabs® Launches LyoPrime Luna® RT-qPCR ... - NEB", "url": "https://www.neb.com/en-us/about-neb/news-and-press-releases/new-england-biolabs-launches-lyoprime-luna-rt-qpcr-master-mix-the-first-lyophilized-product-since-its-acquisition-of-fluorogenics", "description": "This lyophilized master mix exhibits the same versatile features and strong performance of the previously released liquid 4X mix and enables", "position": 1 }, { "title": "LyoPrime Luna® Probe One-Step RT-qPCR Mix with UDG - NEB", "url": "https://www.neb.com/en-us/products/l4001-lyoprime-luna-probe-one-step-rt-qpcr-mix-with-udg", "description": "Room-temperature stable, lyophilized one-step RT-qPCR master mix for sensitive detection of target RNA sequences in glass vial and 96-well plate pack sizes.", "position": 2 }, { "title": "New England Biolabs® Launches LyoPrime Luna™ RT-qPCR ...", "url": "https://www.cambridgenetwork.co.uk/news/new-england-biolabsr-launches-lyoprime-lunatm-rt-qpcr-master-mix-first-lyophilized-product-its", "description": "The lyophilized mix also contains Murine RNase Inhibitor, dNTPs, and a passive reference dye, offering compatibility across multiple instrument", "position": 3 }, { "title": "Protocol for LyoPrime Luna® One-Step RT-qPCR Mix with UDG, 96 ...", "url": "https://www.neb.com/en/protocols/protocol-for-lyoprime-luna-one-step-rt-qpcr-mix-with-udg-96-well-plate-neb-l4001p", "description": "The LyoPrime Luna Probe One-Step RT-qPCR Mix with UDG (NEB #L4001P) is provided lyophilized in a 'ready-to-use' 96-well plate format and is shipped and", "position": 4 }, { "title": "LyoPrime WarmStart® Fluorescent LAMP/RT-LAMP Mix (with UDG)", "url": "https://www.neb.com/en-us/products/l4401-lyoprime-warmstart-fluorescent-lamp-rt-lamp-mix", "description": "Room-temperature stable, lyophilized LAMP/RT-LAMP master mix for detection of target nucleic acid sequences in glass vial and 96-well plate formats.", "position": 5 }, { "title": "LyoPrime Luna® L4001S Vial Format Rehydration - NEB", "url": "https://www.neb.com/en-us/tools-and-resources/video-library/lyoprime-luna-l4001s-vial-format-rehydration", "description": "This video describes the rehydration process for LyoPrime Luna™ Probe One-Step RT-qPCR Mix with UDG, a lyophilized reagent analogous to our liquid format", "position": 6 } ], "lyophilization CDMO IVD reagents contract development manufacturing organization": [ { "title": "LEADSPHERE™ Lyophilization Technology", "url": "https://www.leadgenebio.com/news/detail/20220907_lyophilization_technology_en", "description": "Leadgene Biomedical, Inc., an ISO-certificated contract development and manufacturing organization (CDMO) company that provides integrated", "position": 1 }, { "title": "Life Sciences & IVD Contract Manufacturing - Argonaut Manufacturing Services", "url": "https://www.argonautms.com/ivd-manufacturing", "description": "A:\n\nA Contract Development Manufacturing Organization (CDMO), is a company that provides comprehensive services to biotech and pharmaceutical companies related to the development, manufacturing, and testing of drugs and other biotechnology products. CDMOs offer a wide range of services, including supply chain management, technical transfer, engineering development, first article builds, cGMP (current Good Manufacturing Practices) manufacturing, and quality and regulatory services. [...] Risk mitigation: By working with a contract manufacturing organization, biotech companies can mitigate the risks associated with life science and IVD manufacturing, such as potential production delays or issues with regulatory compliance. CDMOs have established quality management systems and follow cGMP guidelines, ensuring that the final product meets regulatory requirements. [...] Every journey to contract manufacturing is unique. Some life science & diagnostic companies know, at the start, they want to work with a contract development and manufacturing organization (CDMO), while others choose to engage a CDMO later in the product design process or even after production has started. While flexible providers will accommodate companies at any stage of their process, when is the right time to select a biotech contract manufacturer? Examining the pros and cons of early,", "position": 2 }, { "title": "Contract Manufacturing - Lyophilization - Worldwide", "url": "https://biopharmguy.com/links/company-by-name-cm-lyophilization.php", "description": "| Curia | NM - Albuquerque | Curia (formerly AMRI) is a CRO/CDMO providing discovery, development, drug substance and drug product manufacturing for small molecules and biologics across 20 global sites. |\n| Add'l LocationsAalto Scientific | GA - Eatonton | Contract Reagents, Proteins | [...] | Add'l LocationsCuria | UK - Glasgow | Curia (formerly AMRI) is a CRO/CDMO providing discovery, development, drug substance and drug product manufacturing for small molecules and biologics across 20 global sites. |\n| Add'l LocationsDIVERCHIM CDMO | France - Roissy-en-France | Small Molecule Drug Substance CDMO |\n| Add'l LocationsFortis Life Sciences | MA - Boston | Reagents, antibodies, enzymes and lateral flow assay components, plus CDMO, contract R&D services | [...] | Abzena | CA - San Diego | Abzena is the leading end-to-end bioconjugate & complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. |", "position": 3 }, { "title": "Reagent Contract Manufacturing | In Vitro Diagnostics (IVD)", "url": "https://affinitylifesciences.com/services/reagent-kit-manufacturing", "description": "Affinity Life Sciences specializes in lyophilization (freeze drying) contract manufacturing, offering formulation, cycle development, and production", "position": 4 }, { "title": "Lyophilization Contract Manufacturing Services: What to Know", "url": "https://ascendiacdmo.com/newsroom/lyophilization-contract-manufacturing", "description": "When selecting a contract development and manufacturing organization (CDMO), it’s important to find one that meets your specific needs and requirements. You should evaluate each company’s capabilities, including their experience and expertise in lyophilization, as well as their production capacity and turn-around time. [...] In this article, we'll discuss the basics of lyophilization in the pharmaceutical industry, along with tips on how to select a contract development and manufacturing organization (CDMO) for lyophilization outsourcing.\n\n## What Is Lyophilization? [...] Companies should look for a partner with a proven track record in the industry who can provide the necessary equipment, cycle development, and cGMP compliance. With the right CDMO, your lyophilization process will be safe and effective.\n\nRelated Read: cGMP vs GMP: What's the Difference?\n\n## Finding the Right Partner for Lyophilization Contract Manufacturing Services", "position": 5 }, { "title": "Contract Manufacturing and Development Organizations (CDMO) | MTEC", "url": "https://mtec-sc.org/capabilities/Contract-Manufacturing-and-Development-Organizations-CDMO", "description": "Harmac is a global contract design and manufacturing organization specializing in single-use medical devices. With over four decades of experience, Harmac provides comprehensive services including product design and development, advanced manufacturing, automation, value engineering, quality assurance, and packaging and sterilization. The company is known for its operational excellence, regulatory compliance, and commitment to sustainability and community engagement. Harmac operates facilities [...] Capabilities /\n\n# Contract Manufacturing and Development Organizations (CDMO)\n\nContract Manufacturing and Development Organizations (CDMOs) deliver GMP-compliant scale-up, formulation, analytic development and sterile fill–finish for biologics, cell and gene therapies, medical devices and small molecules. CDMOs enable rapid tech transfer, quality systems and regulatory strategy to convert laboratory innovations into deployable medical countermeasures for military and civilian use. [...] ### Lyophilization, formulation and cold-chain solutions\n\nStabilizing formulations, freeze-drying and validated cold-chain packaging extend shelf life and enable distribution to remote or austere environments.\n\n### Additive manufacturing and rapid prototyping for devices\n\n3D printing and rapid prototyping support iterative device design, small-batch production of mission-specific tools and on-demand spare parts for medical systems.\n\n## Importance to Military Medicine", "position": 6 } ], "freeze-dried PCR reagents stability accelerated study room temperature": [ { "title": "Transferable, easy-to-use and room-temperature-storable ...", "url": "https://www.sciencedirect.com/science/article/abs/pii/S0039914021007189", "description": "by J Xu · 2021 · Cited by 23 — Through accelerated stability testing, the evaluation period for freeze-dried PCR mixes was shortened from 1 to 2 years to less than 1 month.", "position": 1 }, { "title": "Transferable, easy-to-use and room-temperature-storable ...", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8353973", "description": "by J Xu · 2021 · Cited by 23 — Accelerated stability testing can be used to shorten the evaluation period (v) dried PCR mixes. at 56 °C and 80 °C.", "position": 2 }, { "title": "Fig. 1 Results of the stability tests of freeze-dried reagents....", "url": "https://www.researchgate.net/figure/Results-of-the-stability-tests-of-freeze-dried-reagents-Electropherogram-of-multiplex_fig1_45407127", "description": "The freeze-dried mixes retained activity at room temperature (18∼25°C) for 28 days, and for 14 and 10 days when stored at 37°C and 56°C, respectively.", "position": 3 }, { "title": "High quality Lyo-Ready PCR raw materials and master mixes, Superior pe", "url": "https://www.yeasenbio.com/blogs/ivd/high-quality-lyo-ready-pcr-raw-materials-and-master-mixes-superior-performance-stable-commercial-supply", "description": "| advantage | 1.Premixed Lyoprotectant, easy to operate 2. Good stability: the liquid reagent can be stably placed at 37℃ for 7 days, and the freeze-dried reagent can be stored at room temperature 3. Freeze-drying forms are various: freeze-drying in situ of eight tubes, freeze-drying cakes of Xilin bottles, freeze-drying balls, freeze-drying microcores, etc | [...] Yeasen's lyophilized microarray shows no significant changes in Ct values, fluorescence values, or spherical shape before and after accelerated heat treatment, indicating good stability of the lyophilized product. RNA lyophilizable reagent (Cat#16645ES) was frozen into a lyophilized microarray and treated under different conditions (normal storage as T0, accelerated at 50℃ for 14 and 25 days), while amplifying SARS-CoV-2 pseudovirus templates at concentrations of 105, 104, and 103 copies/mL. [...] # Advantages of freeze-dried products\n\n Reduce cost and operational complexity\n Support custom freeze-drying formula\n Provide reference freeze-drying process to assist the freeze-drying process\n After freeze-drying, the properties are consistent with liquid reagents, which can keep the enzyme activity intact\n Freeze-dried and still stable at room temperature, can be transported and stored at room temperature\n\n# The freeze-drying form is diversified, and the product has strong adaptability", "position": 4 }, { "title": "In Pursuit of a Shelf-Stable qPCR Mix", "url": "https://opsdiagnostics.com/notes/lyoqpcrreagents.html", "description": "The four week shelf-life study shows that the reagents were stable at 4°C in vacuum sealed pouches. As the data above shows, the freeze-dried mix was less robust than fresh cocktails, but it did not lose a significant amount of activity due to freeze-drying and storing at 4°C. This method for generating a shelf-stable reaction shows promise and will be further investigated and optimized.\n\nAssessment of Freeze Drying Variability in a 96 Well Format [...] Using a freeze-drying formulation incorporating our 2X Lyophilization Reagent, while avoiding glycerol, surfactants, and excessive salt, we were successfully able to freeze-dry PCR reagents in shelf-stable, ready-to-use format. The resulting mixture required only rehydration using molecular biology grade water and PCR buffer prior to adding template DNA for amplification. Reactions using the freeze-dried qPCR mixture were stable, but with slightly less activity than freshly prepared reactions. [...] To test the effectiveness of both the freeze-drying and stability of the reagent, a shelf life study was conducted by running qPCR once a week for four weeks using a stock of Zea mays (corn) DNA. In addition to the lyophilized reagents, a freshly prepared lyophilization reaction mix and a reaction using the Bio-Rad Mastermix were run, both with and without corn DNA. To use the ready-to-use qPCR tubes, the cakes were rehydrated in 19 µl 1X PCR buffer (containing 5 mM MgCl2). Template DNA was", "position": 5 }, { "title": "Room-temperature-storable PCR Mixes for SARS-CoV-2 ...", "url": "https://www.biorxiv.org/content/10.1101/2020.04.07.029934v1.full.pdf", "description": "To verify the stability of the freeze-dried PCR reagents, 12. 161 batches of SARS-CoV-2 PCR reagents were tested using a 10-fold serial dilution", "position": 6 } ] }