Biotech/Biosimilar Products: Current and Emerging Analytical CMC Expectations: 2-Day In-Person Seminar

In the development and commercialization of biopharmaceutical products, historically most of the R&D and GMP attention has been focused on the manufacturing process and production facility. However, there has always been a vital role for the ‘other half’ of the equation: analytical testing and laboratory operations.

The global emergence of biosimilar products – where significant attention is given to analytical characterization and comparability – has turned a brighter spotlight on the analytics. It is expected that rationale for the design and execution of analytical studies, the selection of and validation of appropriate method technologies, the assessment of drug substance and drug product stability, and the establishment of meaningful, supportable specifications will be justified in regulatory dossiers.

This two day interactive course on CMC requirements for biopharmaceutical products will focus on the types of analytical CMC studies that are critical to the successful review and approval of product IND/IMPD and BLA/MAA filings. It will also discuss the vital role of laboratory quality systems in assuring the reliability and integrity of the data generated to demonstrate product comparability, quality and stability.

Upon completing this course on analytical CMC regulations, participants will:

• Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements
• Understand why requirements for biotech products are so different from those of chemical products
• Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents
• See how to implement a staged approach to establishing specifications for release and stability testing
• Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability
• Select the appropriate methods for release and stability testing
• Design suitable qualification and validation exercises for method intended uses
• Establish stage-appropriate ICH stability protocols
• Learn the tiered approach for managing product reference standards
• Recognize how much R&D data are exposed to regulatory scrutiny
• See the new regulatory guidance on quality agreements with contract testing labs

This course is designed for people tasked with designing, conducting, auditing, or managing key CMC studies; writing dossiers or responding to communications for submission to regulatory authorities; preparing for or conducting inspections of analytical labs for biotech or biosimilar products. Following personnel will benefit from the course:

• CMC study directors
• Method development specialists
• Process development specialists
• R&D scientists
• QC technicians
• QC laboratory managers
• Stability program managers
• QA professionals
• CRO personnel
• Technical writers
• Laboratory inspectors
• Regulatory professionals
• Compliance professionals