Brammer Bio: Biologics entering late-stage trials raise capacity concerns, spur $50m investment
The cell and gene therapy contract development and manufacturing organization (CDMO) has completed renovations at its late-stage clinical capacity and commercial-ready cGMP manufacturing site for gene therapy products in Cambridge, MA.
“There is an industrywide concern regarding the capacity for producing these highly complex biologics,” said Mark Bamforth, president and CEO of Brammer Bio.
In order to meet this demand, Brammer Bio invested more than $50m in 2017 to increase its capacity, he told us.
“Brammer has supported early clinical stage products for over a decade at its Florida facility and continues to experience strong demand for process and analytical development and clinical supply,” Bamforth added, noting that some of these products are now maturing to late-stage clinical trials.
“These products, and new ones coming to Brammer from clients with late-stage manufacturing needs, require scale-up, process robustness, and characterization studies to support filing for product licensure,” he explained.
Now, with renovations completed at its Cambridge, MA facility, Bamforth said the company can support clients in Phase III, through licensure, and with commercial supply, including process scale up and qualification for drug substance and drug product production.
The renovation involved “a complete rebuild” of cleanroom areas to support the standards needed for vector product manufacturing and the segregation of products, Bamforth explained. The utility generation systems were also repurposed with new distribution systems.
Additionally, single-use process equipment was installed for manufacturing of viral vector drug substance and drug product filling for gene therapy products, Bamforth added. Quality control laboratories and technical support laboratories were also installed.
The 66,000 square-foot facility, acquired from Biogen in January 2017, was previously licensed to manufacture four commercial protein therapeutic products. In conjunction with the facility purchase, Brammer also took on a team of 100 employees, which it has since expanded to 150.
Scaling up in ‘the year of personalized medicine’
The most recent investment follows in a series of announcements.
In 2016 at BIO International, Bamforth said “we are now entering the year of personalized medicine,” as the company announced a new 50,000 square foot cell and gene therapy manufacturing facility in Lexington, MA.
In the year following, the company invested in a commercial-scale gene therapy manufacturing facility in Cambridge, MA and doubled its early phase clinical manufacturing capacity at its site in Alachua, FL.
