 SAFC Biosciences understands your need for compliant systems and validated processes supported by a robust supply chain to the demands of producing commercialized biopharmaceuticals. We have a proven track record as the leading supplier of critical raw materials, services and support for the manufacture of late stage and commercialized biotherapeutics.
SAFC Biosciences provides specialized cell culture media, feeds and supplements that are produced in cGMP-compliant manufacturing facilities and supported by rigorous quality systems and validated processes to ensure lot-to-lot consistency and yields, delivered on-time and within specifications.
We offer customization and optimization expertise for products and processes to meet the challenges of regulatory compliance, safety and manufacturing efficiency that includes but not limited to:
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Product formulation, packaging, labeling and testing |
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Documentation and regulatory support for required filings |
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Joint demand requirement forecasting |
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Logistics, warehousing and contingency planning |
With SAFC Biosciences as your supplier, your efforts are supported by a dedicated commercial team that includes extensive technical and regulatory expertise. This team is committed to responding quickly and openly to inquiries regarding scale-up and feasibility, supply, quality and documentation. |
Commercialization
Upon completion of Phase III, results are combined into a comprehensive document containing extensive descriptions of methods and results, pre-clinical, clinical and biological data, manufacturing procedures, formulation details and shelf life for regulatory submission.
Tactical focuses at commercial launch include product promotion, sales and distribution efforts. Post market surveillance is on-going to include formulation, stability, bioequivalency and safety monitoring to support regulatory requirements and product improvements. Strategic focus at the time of commercial launch includes ensuring a secure, robust supply chain is in place to meet production demands and initiatives to improve manufacturing efficiencies to achieve required financials become increasingly important. Marketing approval for biopharmaceuticals can vary by country; less than 20% of all initial investigational new drug applications are approved.
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