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Catalent starts manufacture of Passage Bio's lead gene therapy products

7 Dec 2020

The CDMO will provide packaging, labeling and distribution services through its FastChain demand-led supply offering

Production operations are underway at Catalent's dedicated manufacturing suite for genetics medicines-focused Passage Bio after it recently completed the construction and current Good Manufacturing Practice (cGMP) qualification, the contract development and manufacturing organisation said Monday.

The new suite, which is at Catalent's Cell & Gene Therapy facility in Harmans, Maryland, will focus on Passage Bio's product candidates for the treatment of rare monogenic central nervous system (CNS) disorders.

The completion of the dedicated CGMP manufacturing suite results from Passage Bio’s ongoing collaboration agreement with Catalent first announced in July 2019.

To support the production of AAV, Passage Bio is using the Pall Corporation’s iCELLis single-use fixed-bed bioreactor technology. This fully integrated bioreactor system provides a scalable alternative for the cultivation of adherent cells and is capable of meeting demand for both clinical and commercial-scale volumes.

Catalent will deliver Passage Bio’s therapy candidates to clinical trial sites for administration to patients, as well as provide packaging, labeling and distribution services through its FastChain demand-led supply offering, which is particularly well suited to studies of advanced therapy medicinal products where speed, efficiency and flexibility are vitally important.

"Having a dedicated manufacturing suite focused solely on our products allows us to control our critical production supply chain, providing the flexibility and scalable capacity to more rapidly advance our product candidates from clinical trials to commercialization,” said Bruce Goldsmith, president and chief executive officer of Passage Bio.

In addition to its collaboration with Catalent, Passage Bio is also supporting its preclinical programs through its partnership with the University of Pennsylvania’s (Penn’s) Gene Therapy Program, which provides access to preclinical and toxicology research-grade vector supplies.

Alex Fotopoulos, chief technical officer of Passage Bio, said: “Investing in dedicated cGMP manufacturing infrastructure at Catalent, augmented by our access to vector supplies, technology, and expertise at Penn, provides us the flexibility and capacity to advance multiple programs in parallel and to rapidly deliver supplies to support clinical trials worldwide."

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