ABEC CSR® Single-Use Fermenters to Support Catalent Cell & Gene Therapy Manufacturing Expansion
ABEC Custom Single Run (CSR) systems supplied on fast-track schedule to support flexible manufacturing of plasmid DNA
BETHLEHEM, Pa.--(BUSINESS WIRE)--#CSR--ABEC, a leading global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced that it has supplied two 50L CSR single-use fermenters to Catalent Cell & Gene Therapy. The custom designed systems were delivered on an accelerated schedule to meet Catalent’s specific process requirements and address the strong demand for gene therapy manufacturing services. The systems are now in operation at Catalent’s Plasmid production facility in Rockville, Maryland.
Catalent is applying ABEC’s CSR technology to expand its plasmid DNA manufacturing capabilities. The fermenters were designed to provide maximum process flexibility for a variety of plasmid products and to integrate into existing space in Catalent’s Rockville facility. This customized approach, along with ABEC’s capability to deliver the systems quickly, has supported the rapid time to market for Catalent’s advanced plasmid manufacturing services.
ABEC’s CSR fermentation technology delivers process performance comparable to that of stainless-steel systems, ensuring highly productive and scalable fermentation processes. ABEC is also supplying CSR single-use disposable containers (DCs) from its two in-house ISO-7 cleanroom manufacturing facilities in Bethlehem, Pa. and Fermoy, County Cork, Ireland. These facilities, as well as ABEC’s qualification of multiple single-use instrument and component suppliers, ensure a robust supply chain and short DC lead times.
“Catalent is a global leader in gene therapy development and manufacturing services,” said Dr. Thomas VanCott, Catalent’s Global Head of Product Development, Cell & Gene Therapy. “The ABEC CSR fermenters are optimized for our demanding plasmid fermentation processes, and ABEC’s commitment and credibility are essential to support our rapid growth.”
“We are pleased to support Catalent with our industry-leading single-use microbial fermentation technology,” said Scott Pickering, ABEC CEO and Chairman. “Our complete in-house equipment and disposables supply capabilities were also crucial for success in this effort.”
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