Our Manufacturing Capabilities
Targeted Genetics is a leading manufacturer of AAV vectors. We have developed proprietary manufacturing processes for our AAV-based products that utilize scaleable and validatable unit operations commonly used in the commercial biopharmaceutical manufacturing. Our cGMP manufacturing facility features two parallel product trains, each equipped with 100-liter SIP/CIP bioreactors, enabling the manufacture of two products at one time. We have more than a decade of experience in cGMP manufacturing, and have produced clinical supplies of investigational therapies for cystic fibrosis, inflammatory arthritis, HIV/AIDS and other disease indications.
Leveraging our Manufacturing Assets
Our cGMP facility is equipped with standard biopharmaceutical equipment that supports the manufacture of AAV- and other viral-based therapies, vaccines and biologics. Additionally, we have full process development, quality control and quality assurance, regulatory and clinical support capabilities. This suite of assets enables us to contribute AAV manufacturing expertise to our collaborations an important competitive advantage in the development of gene based products. We also leverage these assets to establish contract-manufacturing agreements in which we manufacture clinical supplies for other companies and organizations. As an example, we leveraged our infrastructure and expertise to provide contract manufacturing to GenVec for clinical supplies of TNFerade, an adenovirus-based investigational therapy for the treatment of cancer.
Adeno Associated Virus (AAV) Manufacturing
Our manufacturing capabilities for AAV vectors support multi-trial production needs and are designed to reach maximum productivity, purification, and reproducibility within cGMP guidelines. To date, we have treated nearly 300 people with AAV vectors manufactured using our proprietary processes. With approximately 10 years of patient follow-up data, we have never observed any drug-related serious adverse events in any clinical trial of a product-development candidate. We manufacture clinical supplies of AAV-based therapeutics for our own internal development programs, as well as for collaborative development programs in which we contribute vector design expertise in addition to manufacturing material to support clinical development activities.
Our modular manufacturing processes allow us to optimize our systems for maximum quality and efficiency of a variety of AAV-based products. Additionally, our leadership in AAV-vector design and construction enables us to work with collaborators at both the design and manufacturing stages of numerous product-development programs.
Additional Manufacturing Capabilities
Our manufacturing capabilities, which rely on mammalian cell production in bioreactors, are broadly applicable to the production of viral vectors for gene therapy and may be applied to the production of other biologics. We welcome inquiries regarding contract manufacturing. Please contact BDTGC@targen.com for more information. |
