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.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3.5 hours online.
Over 2 weeks students will learn through:
- Live interactive bitesize sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.
What will you learn?
Phase-specific requirements
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
Product life cycle
Examine the different stages of the life cycle including pre-clinical, clinical trials, commercialisation and post-approval
Analytical considerations
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
Product reference standards
Maintain product reference standards and design successful comparability tests
Comparability tests
Comparability tests
Design and implement successful comparability tests for biosimilars
Product specifications
Product specifications
Learn to set meaningful product specifications, conduct forced degradation studies and manage tech transfer
Methods and protocol
Methods and protocol
Bridge changes in analytical methods and generate effective stability protocols
Lab quality practices
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 professionals who are 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
The analytical side of CMC with course leader, Nadine Ritter
Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).
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.
