Establishing CMC Regulatory Compliance Readiness: When Research Outpaces Regulation

Compliance strategies for biopharmaceuticals and biosimilars are based on five pillars of excellence: The first, that the strategy takes into account the full scope of Chemistry, Manufacturing and Controls activities. Second, that it’s specific to the needs of the biologic in development. Third, and related, it takes into account the manufacturing processes required for the specific biologic. Fourth, that it’s in alignment with ICH Q8/Q9/Q10 guidances. Lastly, a clinical phase-appropriate approach must guide the entire process. Following this five-step protocol ensures Quality by Design in addition to CMC regulatory compliance with FDA standards, or EU and international regulations.

But what happens when the biologics in development are so new to the marketplace that the rules haven’t been written yet? A new study on the cell and gene therapy industry shows that the user acceptance of these treatments may be impacted by the current lack of resources at the FDA. The impacts go beyond resources and staffing. QA challenges are exacerbated by the ballooning number of Investigational New Drugs (INDs) that are seeking approval. It’s difficult to establish CMC regulatory compliance measures considering these constraints.

However, professionals in the CMC regulatory compliance field benefit from training that’s up-to-date and looking ahead of the curve. The CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars course is designed to help attendees make sense of an industry that’s undergoing constant change. In addition to discussion of the gene and cell therapy specialties, our industry professional instructors also cover transgenic plant cell cultures and transgenic animals, vaccines, and the emerging biosimilars market in the U.S. which represents a huge financial opportunity for pharmaceutical manufacturers and developers.

To be a part of this changing conversation, register for the course or call 1-610-648-7550 for more information.

This course is a component of the (BDCP) Biopharmaceutical Development Certified Professional™, (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™ and (PDCP) Pharmaceutical Development Certified Professional™ certification tracks.

Source:

https://www.raps.org/news-and-articles/news-articles/2019/4/establishing-manufacturing-controls-a-hurdle-for