Passage Bio, Catalent Begin cGMP Mfg. for Gene Therapies

Passage Bio, Inc., a genetic medicines company focused on rare, monogenic central nervous system (CNS) disorders, and Catalent, began manufacturing operations 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 follows the recent completion of construction and cGMP qualification of a dedicated manufacturing suite for Passage Bio at Catalent Cell & Gene Therapy’s facility in Harmans, MD.

The completion of the dedicated suite results from Passage Bio’s ongoing collaboration agreement with Catalent from July 2019. Catalent’s commercial-scale facility is located near Baltimore/Washington International Thurgood Marshall Airport, within close proximity to Passage Bio’s corporate headquarters in Philadelphia. To support the production of AAV, Passage Bio is using Pall Corp.’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 also will play an important role in delivering Passage Bio’s therapy candidates to clinical trial sites for administration to patients. Catalent is providing packaging, labeling and distribution services through its FastChain demand led supply offering, to accommodate studies of advanced therapies where speed, efficiency and flexibility are vitally important.

Manja Boerman, Ph.D., president, Catalent Cell & Gene Therapy, said, “With the opening of its CGMP manufacturing suite, Passage Bio has taken a critical step in its commitment to manufacturing excellence. We are pleased to partner our gene therapy manufacturing scale-up expertise and world-class facilities with their scientific leadership to create a pathway for the development and delivery of safe, high-quality gene therapies for patients with rare diseases who are waiting for new treatment options.”