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7 Apr 2021

Catalent boosts plasmid DNA manufacturing at Rockville with addition of ABEC fermenters

The company's custom single run single-use fermenters supplied on fast-track schedule to support flexible manufacturing of plasmid DNA

Catalent Cell & Gene Therapy has boosted capacity at its plasmid production facility in Rockville, Maryland after installing two 50L custom single run (CSR) single-use fermenters supplied by biopharmaceutical manufacturing services provider, ABEC.

The custom-designed systems, which are now in operation, were delivered on an accelerated schedule to meet Catalent’s specific process requirements and address strong demand for gene therapy manufacturing.

Because Catalent wanted to expand its plasmid DNA manufacturing capabilities, ABEC designed the fermenters to provide maximum process flexibility for a variety of plasmid products and to integrate into existing space in the Rockville facility.

ABEC said its CSR fermentation technology delivers process performance comparable to that of stainless-steel systems, ensuring highly productive and scalable fermentation processes.

The company 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, will help to ensure a robust supply chain and short DC lead times, ABEC said.

Catalent took over the lease of Rockville from vaccine firm Novavax in 2019, as part of an $18 million deal.

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