Passage Bio Teams With Catalent to Start cGMP Manufacturing for Lead Gene Therapy Products

Passage Bio, Inc. and Catalent recently 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, MD.

“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.”

The completion of the dedicated CGMP manufacturing suite results from Passage Bio’s ongoing collaboration agreement with Catalent first announced in July 2019. Catalent’s commercial-scale facility is located in Maryland, 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 the Pall Corporation’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, which is particularly well suited to studies of advanced therapy medicinal products where speed, efficiency and flexibility are vitally important.

Manja Boerman, PhD, President, Catalent Cell & Gene Therapy, added “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.”

In addition to its dedicated manufacturing suite and clinical supply through its collaboration with Catalent Cell & Gene Therapy, Passage Bio supports its preclinical programs through its partnership with the University of Pennsylvania’s (Penn’s) Gene Therapy Program, which provides access to preclinical and toxicology research-grade vector supplies.

“Investing in dedicated CGMP manufacturing infrastructure at Catalent, augmented by our access to vector supplies, technology, and expertise at Penn, provides us the flexibility and capacity to advance multiple programs in parallel and to rapidly deliver supplies to support clinical trials worldwide,” said Alex Fotopoulos, MSc, MBA, Chief Technical Officer of Passage Bio. “Our ability to create an agile, global supply chain as we advance our lead product candidates positions us for clinical and commercial success, enhancing our competitiveness in the gene therapy arena.”

With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the US and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated $3 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com.

At Passage Bio, we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvania’s Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. This provides our team with unparalleled access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies into clinical testing. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. For more information, visit www.passagebio.com.