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22-23 October 2019
Radisson Blu Edwardian Kenilworth,

Advanced CMC Analytical Studies and Lab Quality

Undertake a deep strategic analysis of CMC studies to increase efficiency across the board and reduce costly delays caused by non-compliance on this 2-day course.

For biotech and biosimilar products

Course Overview

Explore the technical challenges to designing and executing specific critical analytical studies face-to-face with renowned expert Dr. Nadine Ritter. Practical examples will be provided as illustration for key studies and ample time will be allowed for discussion designs and outcomes. Finally, tips on the suitable generation of internal study reports and the presentation of data for regulatory dossiers will be given.

All attendees will be given a USB drive containing over 1800 global CMC (Quality) regulatory guidance documents, industry white papers and compliance warning letters associated with the development and commercialization of biopharma and biosimilar products.

What will you learn?

Product specifications

Ascertain the main elements which are critical for establishing reliable and meaningful product specifications for biotech and biosimilar products

Characterization and comparability

Review examples of method life cycle studies including what should go into written procedures for characterization and comparability methods

Degradation studies

Examine what kinds of physical and chemical forced degradation studies are applicable to biotech and biosimilar products


Overcome the challenges of developing and validating process-specific host cell protein assays

Reference standards

Explore different types and uses of biotechnology reference standards and materials

Who is this course for?

This course would be useful for:

  • QC release and stability analysts
  • Stability program managers
  • Product scientists and test method technical experts (R&D and QC)
  • Process analytical chemists and process development scientists
  • Quality assurance specialists
  • GMP compliance auditors
  • Regulatory affairs CMC authors or reviewers
  • Analytical and stability laboratory managers (R&D through GMP)
  • Project managers with CMC responsibilities
  • Business managers with CMC responsibilities
  • Key staff from biotech academic incubators and small start-ups
  • Contract testing labs