PHILADELPHIA and SOMERSET, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) — Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that manufacturing operations have commenced to support adeno-associated virus (AAV) production for Passage Bio’s lead gene therapy product candidates for the treatment of rare monogenic CNS disorders. This announcement follows the recent completion of construction and Current Good Manufacturing Practice (CGMP) qualification of a dedicated manufacturing suite for Passage Bio at Catalent Cell & Gene Therapy’s facility in Harmans, Maryland.

“The completion of our dedicated CGMP suite at Catalent is a significant milestone for Passage Bio, enabling us to initiate manufacturing in support of our gene therapy product candidates,” said Bruce Goldsmith, Ph.D., president and chief executive officer of Passage Bio. “Solidifying our manufacturing readiness is a core element in our strategic commitment to deliver innovative gene therapies that are safe and effective for patients with rare CNS disorders. 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.”

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