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       CPD Accredited

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

Key Topics Include...

Biotechnology CMC Regulatory Requirements

Biotechnology Product Specifications; Comparability and Stability Issues

Biotechnology Analytical Methodology

Implementation of Biotechnology Laboratory Tests

Discussion of Ongoing Resources for Biotechnology Analytical CMC Issues

Course Objectives

To provide attendees with a clear, 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 emerging 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 CD 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.

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Dates and Venues

08 Oct 2014 - 09 Oct 2014

Radisson Blu Edwardian Grafton

Performance and Knowledge Objectives

Attendees will be given a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products from the pre-clinical phase through clinical trials to commercialisation and post-approval. Analytical considerations for a wide variety of biopharmaceuticals will be discussed, including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (eg antibody drug conjugates). Details will be presented on establishing and maintaining product reference standards, designing successful comparability tests (including specifics for biosimilar studies), setting meaningful product specifications, conducting
forced degradation studies, tech transfer and bridging changes in analytical methods and generating effective stability protocols. Critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through cGMP will be illustrated.

Why you should attend

  • Create compliant stability protocols
  • Ensure EU and FDA regulatory compliance
  • Identify specifications for release

Download Latest Information Now

(updated 18 December 2014)

Latest Updates

BioProcess Special Report - Recommendations for Cell Banks Used in GXP Assays

Download here:http://www.pti-global.co.uk/event/stabilitybiotech/download/?id=10458


BioProcess Technical: Stability Considerations for Biopharmaceuticals, Part 1

Download here:http://www.pti-global.co.uk/event/stabilitybiotech/download/?id=10459

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