Creating a leading CDMO for cell and gene therapy biologics
Brammer Biopharmaceuticals has merged with Florida Biologix to create a leading cell and gene therapy biologics contract development and manufacturing organisation (CDMO).
The merged company, to be called Brammer Bio, will combine technical expertise in process development and clinical manufacturing with demonstrated capabilities, operating approaches and the quality standards required for commercial manufacturing, the firms said.
Ampersand Capital Partners, the majority shareholder in Florida Biologix, has made an additional investment in the combined company and is the only institutional investor in the merged firm. No financial details have been disclosed.
Brammer Bio will focus 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 aims to double the process development and early-clinical capacity at its Florida location
Brammer Bio occupies 45,000ft2 (4,180m2)of process development and phase I/II clinical manufacturing space in Alachua, FL, and is developing a 50,000ft2 (4645m2) facility in Lexington, MA, with plans to build 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 CEO, and Steven Kasok, CFO, who were previously co-founders of Gallus Biopharmaceuticals, and Dr Richard Snyder, CSO, the founder of Florida Biologix, which was spun out of the University of Florida in 2015.
'There is a rich pipeline of more than 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. 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,' said Bamforth.
Brammer Bio aims 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 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 Snyder.