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CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products

19 - 20 May 2016

Radisson Blu Edwardian Grafton, London

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.

Currently, Dr Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.

  • Gain a comprehensive overview of the phase-specific requirements for CMC analytical characterisation, comparability, release and stability of biotechnology products
  • Examine the different stages of the lifecycle including pre-clinical, clinical trials, commercialisation and post-approval
  • 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)
  • Maintain product reference standards and design successful comparability tests
  • Design and implement successful comparability tests for biosimilars
  • Learn to set meaningful product specifications, conduct forced degradation studies and manage tech transfer
  • Bridge changes in analytical methods and generate effective stability protocols
  • 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

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

An excellent course which answered a lot of questions and concerns


Responsible Analyst, Covance

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