 SAFC Biosciences can facilitate your successful movement through late stage pre-clinical development with expertise in cell line development, purification, regulatory issues, media screening and technology transfer.
We have a 35-year background of clinical project development support and have helped companies move from discovery to successful commercialization; no other supplier can offer the same level of expertise at every stage of development.
Among our offer to you:
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Development of a production cell line:
Development of a working cell bank through discovery of ideal attributes and specifications, clone optimization and selection. |
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Process scaleability:
Assistance with development of a process development scale-up model confirming the process can be completed at a large-scale and verification of productivity, functionality, homogeneity and comparability. |
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Media screening:
High throughput production and feed media screening, media library screening, raw material evaluation, analytical support, imMEDIAte ADVANTAGE™ small volume media services. |
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Technical transfer:
Engineering runs to test the manufacturing process and equipment; determining production parameters; pH, temperature, feeding requirements, cell density, harvest requirements, etc. |
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Regulatory support:
Filing to describe manufacturing process for permission to test in humans, component sourcing and traceability. |
From expression feasibility studies to robust process development, SAFC Biosciences has the knowledge, responsiveness, expertise and track record to move your clinical project through the development pipeline successfully. We have a 35-year background of clinical project development support and have helped companies move from discovery to successful commercialization; no other supplier can offer the same level of expertise at every stage of development. |
Pre-clinical Late Stage
Before clinical trials can begin, pre-clinical studies are required to gather important safety and pharmacology data. Determining a drug's pharmacodynamics (PD), pharmacokinetics (PK), Absorption, Distribution, Metabolism and Excretion (ADME) and toxicity are the main goals of pre-clinical studies.
Tactical focuses during the pre-clinical late stage include animal studies, biological activity, safety and the development of Phase I processes, while the strategic focus is generally speed to clinic and decisions related to expansion of production facilities or use of a contract manufacturing organization.
Data gathered in the pre-clinical phase allows researchers to determine how to dose the drug for clinical trials in humans. To be acceptable for submission to regulatory agencies such as the Food & Drug Administration (FDA), pre-clinical studies must adhere to Good Laboratory Practices (GLP). Typically during pre-clinical studies both in vitro and in vivo tests will be performed. Other studies focus on the drug's toxicity and if there are any long-term carcinogenic effects.
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