 SAFC Biosciences can facilitate your successful movement through early stage pre-clinical development with expertise in platform development, process definition, media selection and by rapidly offering solutions to help move your project to clinic.
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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Screening compounds:
Large-scale transient transfection |
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Research cell banking:
Clone selection and optimization to ensure that the time and money you invest in cell line expansion is well spent. |
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Expression system definition:
The development of a manufacturing & purification process and planning to transfer that raw process to the Process Development group. |
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Process modeling:
Development of a small-scale model with incorporation of processes which will cater to expansion to large-scale. |
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Pilot scale processes:
Determining production parameters; pH, temperature, feeding requirements, cell density, harvest requirements, etc. |
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Pre-clinical Early 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 early stage include process selection, media selection and speed to clinic, while the strategic focus is generally identifying a target or drug candidate.
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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Have a question or just curious?
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