Passage Bio, a genetic medicines company focused on developing adeno associated virus (AAV) delivered gene therapies, will work with Paragon Gene Therapy, a contract development and manufacturing organization (CDMO) and unit of Catalent, to develop a manufacturing suite for clinical and commercial supply production.
In 2018, Paragon built the 150,000-square-foot biomanufacturing facility for the production of clinical batches of gene therapies, which is equipped with 500L and 2000L single-use bioreactors. Previously, the site has worked on the production of rare disease therapeutics.
Stephen Squinto, co-founder and interim CEO of Passage, said in a statement, “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, is a key facet of our business plan.”
Earlier in 2019, Passage completed a $115.5m (€102.6m) Series A financing to advance its portfolio of five product candidates.
Passage’s lead gene therapy candidates will target rare, monogenic diseases, in the form of GM1 gangliosidosis, frontotemporal dementia, and Krabbe disease. The company’s therapies for the diseases will enter the clinic in 2020, and the company also has the option to license seven additional indications.
Both companies involved in collaboration are based in the US, with Paragon housing the current good manufacturing practice (cGMP) manufacturing suite at its Baltimore, Maryland facility. Passage, based in Philadelphia, Pennsylvania, is located near the suite, which is expected to be operational in 2020.
Production of clinical and commercial supply for Passage Bio will use the iCELLis single-use, fixed-bed bioreactor technology to provide scalable manufacturing and cultivation of adherent cells. The company stated that this technology enables it to produce clinical and commercial-scale volumes to meet demand.