Brammer Bio, US cell and gene therapy contract development and manufacturing organization (CDMO), today announced completion of its clinical capacity expansion in Alachua, Florida. This doubles Brammer’s early phase manufacturing capacity to support clients’ Phase I/II cell and gene therapy clinical trials.
Brammer’s Florida site incorporates equipment and facility design concepts that are setting the standard for early clinical supply, and ultimately commercial scale manufacturing of these advanced therapies. Brammer develops analytics and manufacturing processes for the major viral gene transfer vector systems: Adeno-associated viral, Adenoviral, Herpesviral, Lentiviral, and Retroviral. The company uses a range of production and purification platforms, including adherent and suspension up to 500L scale at its Florida operations for manufacturing therapeutic vectors using mammalian and insect cell host systems. In addition, Brammer has installed a state-of-the-art isolator and integrated fill line for drug product manufacturing in a range of formats.
“Our process and analytics development capabilities and manufacturing track record are based on our team’s 11 plus years of experience gained through the successful execution of over 100 projects which have delivered over 150 clinical lots, many for first-in-human trials,” said Dr. Richard Snyder, Brammer’s chief scientific officer. “This translates to best-in-class performance when taking clients from development through the clinical manufacturing phases, successfully completing their projects in accordance with required specifications and regulatory expectations.”
Brammer has invested over $50 million in capacity expansions in 2017 to expand their innovative, early clinical manufacturing in Alachua, Florida, and late-stage clinical capacity and commercial-ready manufacturing capabilities in Cambridge, Massachusetts.
“Our team focuses on right first-time execution to ensure quality and help clients bring their advanced therapeutics from lab to clinic,” added Christopher Murphy, chief manufacturing officer at Brammer. “This added capacity is needed to meet the needs of a growing gene therapy pipeline, and it enables us to introduce new technologies into our drug substance and drug product manufacturing.”
Brammer currently has a team of 300 biopharmaceutical professionals including over 160 based in Florida. The company announced earlier this year the establishment of its Massachusetts facilities for late-stage clinical and commercial production of cell and gene therapy products.