CMC Regulatory Compliance for Biopharmaceuticals

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of genetically-engineered viruses and cells as medicinal products.

These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory compliance requirements for these challenging products. Companies clearly understand the critical importance of their human clinical study strategy, but frequently, the development of a strategy for CMC is an afterthought. Add the frequent lack of CMC regulatory compliance experience in some companies, coupled with the complexity of the biological manufacturing processes and products, and this can be a recipe for disaster.

This presentation will provide insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and human cells) from early clinical stage development through market approval. The course emphasis will include FDA, EMA and ICH guidance.