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Dedicated cGMP suite to be built under partnership agreement with Paragon Gene Therapy
July 10, 2019
By: Cassandra Gervolino
Passage Bio has entered into a collaboration agreement with Paragon Gene Therapy for the development of a dedicated manufacturing suite at their facility near Baltimore, MD. The suite is expected to be operational in the second half of 2020. Passage Bio will be using the iCELLis single-use fixed-bed bioreactor technology, a fully-integrated bioreactor system, which provides a scalable alternative for the cultivation of adherent cells, allows for a more robust and reproducible process and is capable of meeting demand for both clinical and commercial-scale volumes. “We understand that manufacturing is a critical part of a successful gene therapy program and securing our own dedicated manufacturing suite, through this new strategic partnership with Paragon Gene Therapy, is a key facet of our business plan for Passage Bio. We look forward to the build-out of this facility soon,” said Stephen Squinto, co-founder and interim chief executive officer at Passage Bio. “This milestone is evidence of how our team is applying its deep orphan drug development, manufacturing and commercialization know-how to ensure we are able to most efficiently advance our therapies through clinical development and subsequently to ensure they are readily available to patients upon approval.” Pete Buzy, president of Paragon Gene Therapy, added, “We are pleased to be able to support Passage Bio throughout their clinical and commercial milestones. We highly value partnering with our clients to achieve successful patient treatments. Combining Passage Bio’s scientific knowledge with our world-class facilities and extensive AAV scale-up expertise perfectly aligns with our strategic goals in this time of gene therapy growth.”
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