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Our Production Chemicals and Sourcing Services includes a portfolio of market-leading chemical brands for use in cGMP manufacturing, as well as services specific to sourcing, supplier management, and second sourcing assistance.
These services—while not a substitute for specific customer responsibilities in the highly regulated bioprocessing environment—can contribute to significant productivity improvements. Our capabilities drive customer value across risk mitigation, operational efficiencies, and total cost of ownership (TCO).
Our access to a global network of suppliers ensures a comprehensive portfolio that covers all chemical categories across the bioprocessing workflow, as well as addressing any unique needs specific to a project or product development. We offer a wide variety of multi-compendial chemicals, both through external manufacturers as well as our internal manufacturing.
Product availability may vary by country and is subject to varying regulatory requirements. Please contact your local sales representative or call 1-919-598-1986 for availability.
Acids and bases are used to adjust the pH of fermentation and cell culture vessels, and they are used to optimize pH conditions for the drug product during harvest, purification, and fill/finish. The pH of drug formulations greatly affects their biopharmaceutical properties.
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Various grades and concentrations are available.
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Amino acids are one of the basic building blocks of life. They are an essential component of upstream cell culture and fermentation. Some amino acids are also used downstream to stabilize finished drug product in the fill/ finish step.
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Various grades are available.
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All living cells must be maintained in a delicate pH balance for optimal functionality. Organisms naturally have mechanisms of regulating pH, but in the biomanufacturing process protein molecules and other cellular components must be stabilized through carefully engineered biochemical methods. Biological buffers are high purity chemicals that are used to stabilize pH in upstream and downstream workflows.
Product examples
Various grades are available, including low bioburden, low endotoxin, excipient, and API grades.
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Biomanufacturing processes require the use of high purity biological reagents in order to carry out many of the upstream and downstream engineered processes. For example, biological reagents are used in product harvesting to separate crude product from microbial mass and other solids and liquids to prepare for purification. These reagents are also used in purification, chromatography, and final fill/finish.
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Various grades are available.
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Every living organism needs energy to survive. Carbohydrates are the main source of energy for all living things, including cultured cells in the biomanufacturing process. They also act as stabilizing components, and many drug formulations specify carbohydrates in the final fill/ finish.
Product examples
Various grades are available, including low bioburden, low endotoxin, and excipient grades.
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The cleaning of chromatography resins is vital to the safety, quality, and integrity of the final drug product. Our portfolio offers a range of effective cleaning and preservation materials to increase column life and optimize column performance. Columns are expensive components of the biomanufacturing workflow, and can be reused, but only if they are properly preserved and maintained for long term storage.
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Various grades, concentrations, and blends are available.
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Cleaning and sterility assurance are critical elements of maintaining a cGMP bioproduction environment. We offer high grade cleaning materials in a variety of package configurations in addition to technical support to evaluate and meet your needs.
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Various grades and concentrations are available.
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Denaturants are important in upstream and downstream bioprocessing. They are used to break down cellular components in harvest and collection so that the drug product can be isolated effectively. Denaturants are used downstream in purification to ensure the proper folding of the desired components of the mixture while inactivating and removing the components that are not desired.
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Various grades and concentrations are available.
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Emulsifiers, also referred to as surfactants, are utilized in bioproduction to prevent surface absorption and to stabilize protein aggregation. These chemicals are important upstream for harvest as well as downstream for fill and finish. Emulsifiers provide long-term stability of the final drug product during storage and transportation.
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Various grades are available.
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Water for Injection (WFI) is used upstream and downstream in the production of process liquids and solutions where endotoxin content must be controlled. It is sterile, non-pyrogenic and must meet all standards for purified water and undergoes additional bacterial endotoxin testing.
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Various grades are available.
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Used primarily in upstream processes, the selection of high-grade media supplements can greatly impact the performance and yield of cultured cells. These components are critical in ensuring a successful biomanufacturing outcome.
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Various grades are available.
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Minerals and vitamins are important as cell culture supplements to ensure the optimal nutritional and metabolic profile of cultured cells in upstream workflows. Different cell lines and cell growth conditions require a different mix of minerals and vitamins to optimize performance.
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Various grades are available.
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* This supplier only supplies vitamins, not minerals.
Living organisms are essentially vessels filled with salt dissolved in water. All molecules of life, including biologic drugs, need an optimized salt environment in order to be stable, and to function most effectively. Salts are used in upstream and downstream biologics manufacturing and are functionally important for cell culture optimization and protein stabilization.
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Various grades are available.
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Solvents are widely used for both cleaning of purification columns and for recovery and concentration of drug product. These are used upstream and downstream, as well as for larger scale applications such as cleaning of lines and surfaces in biomanufacturing facilities.
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Various grades are available.
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Service availability may vary by country. Please contact your local sales representative for availability.