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18-19 May 2020
Radisson Blu Edwardian Kenilworth,

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

Book with earlybird pricing now!

Receive £100 off if you book before 18 March 2020

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.

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