As advanced therapy developers approach approval and commercialization, they adopt increasingly robust risk-based approaches to ancillary material qualification. Ancillary material qualification is defined by USP 1043 as “the process of acquiring and evaluating data to establish the source, identity, purity, biological safety, and overall suitability of a specific ancillary materials.”
As advanced therapies progress through the clinical pipeline, the integrity of the materials used during manufacture becomes increasingly critical. This session focuses on the challenges that human blood-derived ancillary materials pose, and on the strategies employed by suppliers to mitigate the potential risks they present.
These include extensive donor-screening practices and testing for infectious transmissible agents, the application of current good manufacturing practices (cGMP) during production, and the implementation of robust safety testing on the finished products. In addition, the implementation of viral inactivation processes offers an additional layer of safety as well as lot-to-lot consistency.
Robust viral inactivation permits broader donor pooling, thereby yielding a more consistent product without compromising safety. Advanced therapy developers must implement fundamental approaches of risk management to the assessment and control of ancillary materials. This session will discuss strategies for how to ensure the integrity of ancillary materials in the manufacture of advanced therapy products, focusing on the specific case of how to mitigate risk in the selection and qualification of human blood-derived products.
Register for this webinar to learn about strategies for ensuring the integrity of ancillary materials in the manufacturing of advanced therapy products.
Robert Margolin, Vice President of Global Sales, Akron Biotech
Robert Margolin brings 14 years of business leadership and sales experience in the cell and gene therapy market, with a focus on business development and corporate strategy and execution. His experience ranges across cell therapy drug product and ancillary material manufacturing. Robert’s deep knowledge of clinical and commercial operations has driven process development, scale-up, and design and configuration of electronic systems and logistics platforms for each stage of development. Robert has worked closely with the field’s leading companies and industry organizations throughout the U.S. and Europe. Additionally, Robert played an instrumental role in the formation and growth of the Alliance for Regenerative Medicine, serving as its Vice President of Communications, along with launching several of the field’s preeminent conferences and events. Robert’s network spans the entire industry encompassing KOLs from business, science, medicine, regulatory, policy and advocacy.Message Presenter
Richard McFarland, PhD, President, Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) & Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI)
Dr. Richard McFarland came to ARMI from the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career spanning 16 years involved review of an extensive range of products, and policy development in numerous areas inside FDA, across the federal government, and internationally. He spent more than a decade as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT) and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).
In addition to development of risk-based regulatory oversight paradigms within FDA, his interests included broader efforts to create an interlocking network of interagency efforts to foster growth of basic and translational science to support maturation of the overlapping fields of tissue engineering and regenerative medicine from primarily discovery science toward a stage of commercial development. In his position at ARMI, he applies his knowledge and experiences to ARMI’s creation of a Manufacturing Innovation Institute within the Manufacturing USA network, to coalesce the field and get tissue-engineered and ancillary products the marketplace. In addition to FDA policy documents, he has co-authored over 25 articles in peer-reviewed articles journals including Nature, Proceedings of the National Academy of Science (PNAS), Science-Translational Medicine, and Blood.Message Presenter
Who Should Attend?
- Process Development
- Product Development
- Supply Chain
- Senior Scientist
- Quality Assurance
What You Will Learn
In this webinar, participants will learn about:
- The challenges posed by human blood-derived ancillary materials
- The strategies employed by suppliers to mitigate these risks
- A layered approach to providing safe and effective therapeutic biologics
Akron Biotech drives advanced therapy development and commercialization with high quality, industrial scale solutions. Akron’s strategic focus is supplying cGMP-compliant ancillary materials and services to enable the advancement of cell and gene therapies. These include cytokines and growth factors, human sera and purified proteins, cryopreservation solutions, plasmid DNA manufacturing and custom development services. In addition, our services and capabilities such as raw materials qualification, logistics and packaging optimization, bioassay design, validation, and regulatory services provide our customers with unique knowledge and expertise. As a regulatory compliant company (ISO certified), Akron supports clients with rigorous documentation and quality standards to fulfill their regulatory demands. Our unique capabilities allow us to seamlessly transition from R&D to preclinical and clinical development with minimal change control, and thus drive the emerging regenerative medicine sector to unmet clinical needs through affordable and seamless manufacturing options.