Gene therapy clinical studies are generating positive clinical results at an accelerating rate, with FDA approvals in 2017 and multiple products expected to be licensed in the near future. 

 

Brammer Bio has the experience and capacity to support the rapidly evolving gene therapy industry. Our comprehensive CGMP (Current Good Manufacturing Practices) gene therapy services include manufacturing and analytical testing of viral vectors for in vivo and ex vivo clinical applications. Our organization understands the unique challenges clients face in this field, and we provide the technical experience and operational capability needed to bring breakthrough therapeutics from process development through clinical trials and, ultimately, commercial supply.

  • Custom media optimization, production, sourcing, and testing

  • Process and analytical method development and qualification

  • Large-scale and small-scale closed-system manufacturing and process
    validation

  • Mammalian and insect cell production platforms

  • Chromatographic, centrifugal, and filtration-based separations

  • Full-range of production platforms including flat stock, 50L - 2000L stir tank, perfusion, etc.

  • Drug product fill and finish, storage, and distribution

  • Global quality compliance and regulatory support

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