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Case Studies

Syner-G Helps Biotech Firm Successfully Advance Life-Saving Drug Through Manufacturing Startup and Clinical Trials

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 in kidney transplant recipients.

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Advancing Biotech Drug Development: Syner-G BioPharma’s Collaborative Approach to Chemistry, Manufacturing, and Controls

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 candidates on…

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Synthesizing Success: Syner-G’s Strategic Solutions for Elevating a Biotech Innovator

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 therapeutic potential to treat a wide range of mental…

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Regulatory Expectations for Sterile Filtration Process Control

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…

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