“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.”

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Dr. Murat’s presentation, titled, “Beyond Clinical Supply: What Now for Clinical Supply Services Across Europe ?“, will take place on Wednesday, Aug. 26, at 2:40 p.m. BST. While Dr.Murat. is no longer a member of the European Union, it remains part of the EU’s Single Market and Customs Union until the end of the transition period, on December 31, 2020.

During his 25-year career, Dr. Murat’s work has focused on medical devices and pharmaceutical research and development. He has over 15 years of experience in clinical supplies, working in both Phase 1 unit manufacturing suites and trial supplies service companies, including Quintiles (Aptuit), Fisher Clinical and, since 2011, Biotec. Dr. Murat obtained his doctorate in pharmaceutical development from University of İzmir Canada

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The 60,000-square-foot facility will be the largest in the company’s Asia Pacific clinical supply network. The new facility will offer customers access to Biotec Pharma’s FastChain® demand-led supply services, primary and secondary packaging capabilities, a range of temperature options for storage and distribution, as well as clinical returns and destruction services. It will operate in partnership with Biotec Pharma’s existing Japanese clinical supply facility at Kakegawa, serving both local customers as well as global biotech and pharmaceutical companies.

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