The Chemistry, Manufacturing & Controls (CMC) landscape of biologics is undergoing rapid development and constant change. Manufacturing processes now include transgenic plant cell cultures and transgenic animals. In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy). Biosimilars are now on the marketplace in Europe, and under review for commercial approval in the USA. Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu). Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).
Therefore, it is most important for a biologic company to have an effective CMC regulatory compliance strategy that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary from a CMC regulatory compliance perspective to be successful in getting our biopharmaceutical/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?’ Deficiencies in CMC regulatory compliance have resulted in devastating clinical holds and market approval delays.
This course will help the attendee to develop a CMC regulatory compliance strategy for biologics, addressing the five core elements that comprise an effective strategy: (1) embracing the full spectrum of CMC activities, (2) addressing unique requirements for specific biologic manufacturing processes, (3) addressing unique requirements for specific biologic products, (4) aligning with strategic ICH Q8/Q9/Q10/Q11 guidances, and (5) applying a clinical phase-appropriate approach. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed.
Who Should Attend
This two-day CMC regulatory compliance course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategy for biopharmaceutical and biologic drug products. Typical attendees include: Project Managers, Regulatory Affairs, Manufacturing, and Quality and Development personnel.
At the end of the two-day course attendees will:
- Gain a solid understanding of the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH) for biopharmaceuticals and biologics, and understand why regulatory authorities treat biologics different than chemical drugs
- Have the tools and understanding to carry out an adequate and appropriate product comparability study after a change in a biologic manufacturing process, and to communicate and defend the study to a regulatory authority
- Learn how to avoid major delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy for biologics