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27 Sep 2017

Brammer Bio expands "much needed" cell and gene therapy capacity

CDMO partners with Pall Life Sciences to deliver an end-to-end single-use platform solution from upstream to downstream.

Brammer Bio, a cell and gene therapy CDMO, has confirmed expansions in its early clinical-phase facility in Alachua, Florida, and its new Phase III and commercial facility in Cambridge, Massachusetts. The CDMO is currently making enhancements worth $40 million to enable scale-up through Phase III and strengthen commercial client support in Cambridge. At Alachua’s process development and pilot facility, Brammer invested $10 million to double cGMP manufacturing capacity. Both sites will feature Pall Life Sciences enabling technologies for efficient cell and gene therapy manufacturing.

“Since launching in early 2016, our team has rapidly grown to 300, and now we are focused on expanding much-needed capacity for customers. During planning and evaluation phases, Pall Life Sciences was selected as a preferred technology partner for the design, ease of use, and results achieved with Pall’s process equipment,” said Richard Snyder, Chief Scientific Officer at Brammer Bio. “With Pall’s critical process solutions and process support, we look forward to building on more than 100 executed projects and 150 clinical cell and gene therapy lots in Florida — including many first-in-human trials — and 600+ commercial biologics batches produced in Massachusetts.”

Brammer Bio is implementing a range of advanced Pall platform technologies, with Allegro STR single-use stirred-tank bioreactors for cell culture capability up to 500 L in Alachua, and up to 2,000 L in Cambridge. Both facilities will feature iCELLis fixed-bed bioreactors for efficient scale-up of adherent processes with up to 5,000 sq. ft. of growth surface, Allegro XRS 25 bi-axial rocking bioreactors, and a variety of Pall single-use mixers. The downstream purification suite will feature Pall’s state-of-the-art, single-use tangential flow filtration (TFF) systems, Allegro MVP systems for fluid automation, and Allegro single-use chromatography systems.

“This partnership shows our ability at Pall to deliver an end-to-end single-use platform solution from upstream to downstream,” said Mario Philips, vice president and general manager of Pall Biotech. “It is an honour to have our technologies selected by companies such as Brammer Bio, as they work on the next-generation of novel medicines.”

Both facilities remain operational during the expansions, with the Florida expansion now online, and completion of the Cambridge facility targeted for Q4 2017.

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