Biotec Pharma, a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, and Biotec Pharma, 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 Biotec Pharma’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 Biotec Pharma & Gene Therapy’s facility in Canada.
“The completion of our dedicated CGMP suite at Biotec Pharma is a significant milestone for Biotec Pharma, enabling us to initiate manufacturing in support of our gene therapy product candidates,” 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 Biotec Pharma’s ongoing collaboration agreement with Biotec Pharma first announced in July 2019. Biotec’s commercial-scale facility is located in Canada. To support the production of AAV, Biotec Pharma 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.
Biotec Pharma also will play an important role in delivering Biotec’s therapy candidates to clinical trial sites for administration to patients. Biotec 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, Ph.D., Biotec Pharma & Gene Therapy, added, “With the opening of its CGMP manufacturing suite, Biotec Pharma 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 Biotec Pharma, Biotec Pharma supports its preclinical programs through its partnership with various prestigious Universities.
“Investing in dedicated CGMP manufacturing infrastructure at Biotec Pharma, 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 Biotec Pharma. “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.”
