At Akron, we are aware of the need for traceable reagents and raw materials throughout the clinical pipeline. The manufacture of components used in both autologous and allogeneic therapies requires meticulous attention to detail to ensure compliance with changing regulatory standards. Novel therapies have been identified as medical products by regulatory agencies in the US and in the rest of the world, implying a stricter set of guidelines for firms and researchers. Much debate has been generated, and there are still areas that may need clarification. Last April in Strasbourg, the EU regulatory agency, providers, users and academics met for a workshop to discuss the impact and scope of reagent grading on both early stage development and clinical stage cell therapies.
At the International Society for Cellular Therapy (ISCT) North America Regional Meeting on September 8th-11th, 2013, Akron will chair a session on raw materials and lead the discussion on the regulation of the reagents for CT( cell therapies) at every clinical stage. This raw materials session will bring together the US Pharmacopeia, a provider and a user of raw materials, allowing each panelist to discuss their perspective on a number of ideas, including:
- Definition of active substance (AS) vs.finished product (FP) they have not been defined appropriately;
- What is the impact of raw materials used in the ATMP (advance therapy medicinal product) manufacture;
- What is the level of acceptance for the characterization for active substance and finish product. What is the level that these substances allow?
- Acceptability of markers as well as potency assay may not be sufficient; there is a need to generated correlation to biological activity or MOA (mode of action) and clinical outcome
Just to mention a few of the items that we will discuss in Philadelphia. For traceability and transparency in your clinical reagents, use Akron Biotech. We understand the impact that they have on your product and recognize your need to comply with changing regulatory standards. Visit booth #300 at the ISCT North America Regional Meeting on September 8th-11th, 2013. Look forward to seeing you there!