CMC Analytical, Comparability and Stability Studies for Biotechnology Products

July 10, 2012 6:21 AM


Pharmaceutical Training International is organizing the CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products training in London, UK on 24-25 October 2012.

If you attend the 2-days training course, you will be able to:

  • Clarify the latest CMC regulatory requirements for biotech products to ensure successful marketing applications
  • Assess comparability and stability considerations for biotech product specification
  • Design and develop your biotech stability protocols by identifying the key practical details to address
  • Validate your stability testing methods appropriate for each phase of development
  • Identify which characteristics of a biotech product require analytical assessment
  • Follow the ICH, FDA and USP guidelines for analytical method validation
  • Identify and implement key considerations for biotechnology laboratory testing

If you are interested, the website of the training is: www.pti-global.co.uk/stabilitybiotech

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