Brammer Biopharmaceuticals has merged with Florida Biologix to create a cell and gene therapy biologics contract development and manufacturing organization (CDMO). The merged company, Brammer Bio, will combine technical expertise in process development and clinical manufacturing with capabilities, operating approaches and quality standards required for commercial manufacturing.

Brammer Bio is focused on providing clinical and commercial supply of autologous and allogeneic cell therapies, and viral vector products for in vivo and ex vivo therapeutic applications, along with process and analytical development, and regulatory support enabling large pharma and biotech clients to accelerate the delivery of novel medicines and improve patient health.

Brammer Bio occupies 45,000 sq. ft. of process development and phase I/II clinical manufacturing space in Alachua, FL, and is developing a 50,000 sq. ft. facility in Lexington, MA, with plans to build-out large-scale, phase III/commercial ready viral vector manufacturing suites, segregated cell and gene therapy suites, and QC and analytical laboratories for clinical and commercial launch services.

The management team is led by Mark Bamforth, president and chief executive officer, and Steven Kasok, chief financial officer. The two were previously co-founders of Gallus Biopharmaceuticals. Richard Snyder, chief science officer, is the founder of Florida Biologix, which was spun out of the University of Florida in 2015.

“There is a rich pipeline of over 500 cell and gene therapies in the clinic, and many of the large and specialist biotech companies pursuing these promising treatments want to leverage the expertise of a reliable, high-quality CDMO to supply their products for clinical through to commercial use,” said Mr. Bamforth. “Brammer has the necessary laboratory and production capabilities and a highly skilled team of scientists with the development, manufacturing and analytical expertise required to tackle the challenges posed by these novel technologies and help accelerate their transition from the clinic to patients in need.”

Brammer Bio, in combination with Florida Biologix, has a 10-year track record of providing development, clinical-phase manufacturing, and testing services, supporting clients with advanced therapeutic products and processes. Brammer intends to double the process development and early-clinical capacity at its Florida location. Existing and future clients taking their gene and cell therapy projects to phase III and beyond will be supported at the Lexington, MA facility.

“We recently began exploring options for gaining access to larger-scale manufacturing capabilities. With the deep manufacturing and commercial expertise, knowledge of facility design, and implementation of commercial quality and regulatory systems that Mark and Steven bring to the table, the marriage of Florida Biologix’s early client pipeline with Brammer Biopharmaceuticals is a perfect fit,” said Mr. Snyder.