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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

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.

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Dates and Venues

11 Jun 2015 - 12 Jun 2015

Radisson Blu Edwardian Grafton, London

01 Oct 2015 - 02 Oct 2015

Radisson Blu Edwardian Grafton, London

Performance and Knowledge Objectives

  • 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

Why you should attend

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

Download Latest Information Now

(updated 28 March 2015)

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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