BridgeBio Pharma and Catalent have entered a collaboration agreement to establish dedicated gene therapy development and manufacturing capacity at Catalent’s Paragon Gene Therapy clinical and commercial manufacturing center in Harmans, MD. The agreement is intended to support the clinical and commercial manufacturing needs for BridgeBio’s gene therapy product candidates for congenital adrenal hyperplasia, BBP-631, and Canavan disease, BBP-812.
 
Catalent’s commercial facility is fully compliant with cGMP requirements and allows for up to 5000 liters of production. The over 400,000 square feet footprint is complete with all necessary support functions for storage and fill finish for final product supply.
 
“Having flexibility and greater certainty in manufacturing capacity is critical to success in gene therapy,” said Eric David, chief executive officer of BridgeBio’s gene therapy subsidiaries. “Catalent’s Paragon Gene Therapy arm has been our trusted partner for almost two years, and this expansion of our relationship is intended to allow for smoother clinical and commercial development, as well as an acceleration of our pipeline programs, helping us move faster to address critical unmet health needs for patients and their families.”
 
“Catalent’s expertise in the cGMP manufacturing of viral vectors complements our internal investment in the CMC process and analytical development to support our gene therapy portfolio,” said Fred Porter, senior vice president of CMC and technical development of BridgeBio’s gene therapy subsidiaries. “Securing dedicated capacity for the delivery of clinical and commercial supply is critical to our long-term strategy.”
 
Pete Buzy, president of Paragon Gene Therapy, said, “It is Catalent’s continued goal to grow with our customers and to be able to offer them secure, state-of-the-art gene therapy facilities for their critical clinical and commercial needs. For gene therapies, the manufacturing scale-up process is complex and unique. Therefore, for our partners, having access to advanced adeno-associated virus production expertise and experience is vital to progress these pioneering treatments towards commercialization and the patients who need them.”