Passage Bio Announces New Dedicated Gene Therapy Manufacturing Suite

Passage Bio, a genetic medicines company developing AAV-delivered gene therapies for the treatment of rare monogenic central nervous system diseases, announced that it has entered into a collaboration agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for the development of a dedicated manufacturing suite at their facility near Baltimore, Maryland.

The new cGMP suite will be built in accordance with global regulatory guidelines and will be capable of supporting Passage Bio from clinical through commercial supply. The suite is expected to be operational in the second half of 2020 and will be located in Harmans, Maryland, which is five miles from the Baltimore Washington Airport and within close proximity to Passage Bio’s corporate headquarters in Philadelphia, Pennsylvania.

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.”

This manufacturing partnership follows a successful Series A financing by Passage Bio earlier in 2019 for their development portfolio of five therapeutic candidates.