Merger prepares for 'tidal wave' of gene therapy products
The new contract development and manufacturing organization (CDMO), which will operate under the name Brammer Bio, will focus on autologous and allogeneic cell therapies as well as viral vector products for in vivo and ex vivo therapeutic applications.
Brammer Bio currently occupies 45,000 square-feet of process development and phase I/II clinical manufacturing space in Alachua, FL, and is in the process of developing a 50,000 square-foot facility in Lexington, MA.
The company also 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 legacy and the future
The merger brings together Florida Biologix’s 10 year legacy in process development and phase I/II manufacturing with Brammer Biopharmaceuticals’ phase III facilities and organization.
“In very short order we saw that there was a great opportunity,” Mark R. Bamforth, President and CEO, Brammer Bio, LLC, told Outsourcing-Pharma.com.
“Florida Biologix had already established a strong base of clients doing process development and phase I and II clinical manufacturing,” he added. “They have clients who are progressing to phase III, but they don’t have phase III facilities or the organization in place to support phase III manufacture.”
With the merger, Brammer has doubled Florida Biologic’s early clinical manufacturing capacity in Florida, in addition to building out the phase III and commercial manufacturing facility in Massachusetts.
“We see tremendous opportunity for organic growth with the two sites and the building out plan,” added Bamforth, who predicted that the facilities could reach up to 200 people at each site.
The company also has other active discussions looking at potential to add additional companies and or facilities.
“Part of that is characterized by the number of small CMOs in this industry that have grown up out of academia or in incubators, so there some opportunities to potentially add additional companies,” said Bamforth.
Manufacturing and medicine personalized
“I think now there’s a very exciting environment where there are more than 500 molecules in clinical trials for cell and gene therapy. There really a tidal wave of products coming though the clinic,” said Bamforth. “But there isn’t enough manufacturing established to support these products, and that’s really where our business plan comes into play.”
Bamforth predicts a revolution in personalized medicine within the next five to 10 years – an expectation which aligns with the company’s tag line, Manufacturing Personalized.
“As a CMO we believe that manufacturing personified is about responding to that need for individual treatment, but it’s also in the way that we deal with our clients,” he explained.
According to Bamforth, this revolution is inevitable because today there are almost no gene therapy products approved in the World; however, he explained that in the last 20 years there has been about $5bn invested in gene therapy research, which has led to a greater understanding of gene therapy.
“So there is about a $1.5bn to $2bn end market for cell therapy products today,” said Bamforth. “If you could impact disease and cure them through gene therapy … that would be transformative for patients and for health.”
