ABOUT The client is a clinical-stage biotechnology company focused on the phase III development of an anti-interleukin-6 monoclonal antibody therapeutic for the potential treatment of chronic active antibody-mediated rejection, the leading cause of long-term rejection...
ABOUT The client is a U.S.-based clinical-stage biotechnology company using artificial intelligence (AI) and human data to transform drug discovery and development. The company uses machine learning to map the complex causes of diseases to develop proprietary drug...
ABOUT The client is an emerging biotechnology company focused on developing and commercializing patient-friendly compounds to treat psychiatric and neurological disorders. The company is developing breakthrough non-hallucinogenic psychedelic derivatives with the...
Sterile filtration is a critical process step in the production of injectable drug products and is used to remove microorganisms and particulates from a product stream to ensure purity and sterility of the product. Manufacturing controls are required to successfully...
Challenge The client lacked the internal resources to review and validate its strategy and approach to its first commercial program. They needed CMC support for their first drug which has “breakthrough” designation. The client embraced the outsourced model and knew it...
Challenge Syner-G was contracted by a Canadian Pharma Company to perform an emergency Investigation Audit triggered by an OOS of a time-critical Phase II supply at a CDMO site in India. Results Syner-G mobilized two of its experts (locally available in India)...
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