 SAFC® 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 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 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. |
Phase III
Phase III trials are conducted to confirm drug efficacy. These trials are expensive with costs in the millions of dollars and can on average, take three to five years to complete. Results from a Phase III trial are used to set dosage, frequency and duration of administration in certain patient groups.
Tactical focuses during Phase III include method validations, process lock-down, product characterization, including stability and lot-to-lot consistency and yields. Strategic focus includes preparations for regulatory fillings for market approval, product launch and ensuring a robust supply chain for critical raw materials.
Upon successful completion of a Phase III trial, results are combined into a large, comprehensive document containing extensive descriptions of the methods and results preclinical, clinical and biological data, manufacturing procedures, formulation details and shelf life for regulatory submission.
The legal requirements for marketing biopharmaceuticals vary by country. To obtain marketing approval in the United States, a Biologics License Application (BLA) is submitted to the Food and Drug Administration (FDA) Center for Biologics Evaluation (CBER) or a New Drug Application (NDA) is submitted to the Center for Drug Evaluation and Research (CDER). In Europe, applications are submitted under the Centralized Procedure to the European Agency for the Evaluation of Medicinal Products (EMEA). In Australia submissions are made to the Therapeutics Goods Administration (TGA) and in Japan to the Ministry of Health Labour and Welfare.
During Phase III trials
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Chronic toxicology studies continue and reproductive side effects are investigated and carcinogenicity studies are initiated |
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Method validations and product characterization are performed |
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Testing for stability, consistency and further refining of the drug formulation occurs |
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Equivalency of formulations and processes is assessed |
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Preparatory work for regulatory submissions begins |
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Robust processes and specifications for final formulation, fill-and-finish and transfer to full-scale manufacturing are established |
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cGMP compliance is rigorously enforced |
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