18-19 May 2020
Radisson Blu Edwardian Kenilworth,
London
Introductory CMC Analytical Studies and Lab Quality
Gain an understanding of the practical requirements for biopharm CMC studies to support strategic decisions, budgets and timeframes
For biotech and biosimilar products
Course overview
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including biosimilar products. Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented.
Attendees will be given a USB drive containing a complete set of all regulatory documents and industry white papers currently applicable to biotechnology product analytical CMC requirements that covers the entire product development lifecycle.
What will you learn?
Phase-specific requirements
Gain a comprehensive overview of the phase-specific requirements for CMC analytical characterisation, comparability, release and stability of biotechnology products
Product life cycle
Examine the different stages of the life cycle including pre-clinical, clinical trials, commercialisation and post-approval
Analytical considerations
Discuss analytical considerations for a wide variety of biopharmaceuticals including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates)
Product reference standards
Maintain product reference standards and design successful comparability tests
Comparability tests
Design and implement successful comparability tests for biosimilars
Product specifications
Learn to set meaningful product specifications, conduct forced degradation studies and manage tech transfer
Methods and protocol
Bridge changes in analytical methods and generate effective stability protocols
Lab quality practices
Assess critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through to current GMP will be illustrated
Who is this course for?
This training course is intended for the professional who is involved with stability testing for biotechnology products, directly or indirectly. Professionals from Pharmaceutical, Biotechnology, Drug Delivery and Medical Device companies should attend, such as, but not limited to:
- Stability Directors/ Supervisors/Managers/Analysts/Coordinators
- Laboratory Supervisors/ Managers
- Project Managers/Coordinators
- Quality Control Analytical Chemists
- Research and Development Chemists
- Biostatisticians
- LIMS Administrators
- QA/QC Reviewers
- Validation Scientists
- Calibration/Metrology Groups
- Internal or Independent Auditors
- Manufacturing/Production Managers
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
