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 have been in the marketplace in Europe for almost a decade, and are now 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 the CMC regulatory compliance strategy have resulted in devastating clinical holds and market approval delays.
This course will help the attendee to develop a CMC regulatory compliance strategy for biopharmaceuticals, biosimilars and other 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 the strategic ICH Q8/Q9/Q10 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. In addition, this course will also help the attendee to better understand the CMC regulatory compliance requirements for Quality by Design applications and for biosimilars.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This three-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 biopharmaceuticals, biosimilars or other biologics. Typical attendees include: Senior Management, Project Managers, Regulatory Affairs, Manufacturing, and Quality and Development personnel.
At the end of the three-day course attendees will:
- Gain a solid understanding of the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH, WHO) for biopharmaceuticals, biosimilars and other biologics, and understand why regulatory authorities treat biologics different than chemical drugs
- Have the tools and understanding to carry out an effective product comparability study after a change in a biologic manufacturing process, learning how to avoid the many pitfalls, and how to communicate and defend the study to a regulatory authority
- Understand the CMC challenges for biosimilars under the US FDA, European Medicines Agency (EMA) and World Health Organization (WHO) requirements, especially with the innovator’s CMC development being blinded to the biosimilar manufacturer
- Understand the strengths and limitations of Quality by Design (QbD) - quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs) and justification of the control strategy – for biologic manufacturing processes
- Be able to package the CMC information for biologics into the common technical document (CTD) format, including placement of the CMC biosimilarity study and QbD content
- Learn how to avoid major delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy for biologics
Frequently Asked Questions
Does the course cover both biopharmaceuticals and biologics in clinical development as well as market-approved?
The course covers the Chemistry, Manufacturing & Control (CMC) regulatory compliance requirements and expectations for biopharmaceuticals and biologics in clinical development (i.e., Phase 1 to Phase 3 studies) as well as those having market approval.
Does the course cover FDA and international concerns?
The course covers all aspects of CMC regulatory compliance requirements and guidance for biopharmaceuticals and biologics from the FDA, European Medicine Agency (EMA), and International Conference on Harmonisation (ICH).
How does this course differ from the course QA/QC Strategy for Biologics and Biopharmaceuticals™?
This course systematically covers all aspects of CMC regulatory compliance concerns, including areas of keen interest to regulatory affairs, manufacturing and development for biologics. On the other hand, the QA/QC Strategy course focuses on all aspects of keen interest to quality assurance and quality control, including control systems and setting of specifications and expiry dating of biologics.