Biotech SPIN: ABC Biologics - Maintaining Quality

Biotech SPIN: ABC Biologics - Maintaining Quality
The Biotech SPIN Steering Group is pleased to present this technical webinar exploring the elements involved in delivering quality in the production of biologicals.






Date: Thursday 8 December 2022
Time: 12:00–13:00 GMT/13:00-14:00 CET

Speakers:

Cecil Nick, Vice President (Technical) with Parexel, will speak on the elements of production and structure of biologicals that impact their quality.
Rhydian Howells, Senior Manager, UK Life Sciences & Biotech Regulatory Solutions, KPMG, will speak on the expectations for selection and testing of product characteristics when setting phase appropriate specifications to control the quality and safety of biologicals.

This webinar will introduce the complexity of structure of biologicals and approaches that are applied to control the unique and often molecule specific, characteristics of biologicals.  The relationship between product attributes and characteristics with biological activity, safety and immunogenicity will be explored and the regulatory expectations for detection, characterisation and control of product attributes to ensure the quality and safety of the product throughout clinical development and for licensure will be addressed.

After attending this Webinar participants will:

  • Understand the complexity of biologicals and the need to characterise their structure and attributes using state of the art methods to ensure consistent biological activity, quality and safety.
  • Awareness of the regulatory expectations for appropriate setting of specifications and the selection of molecule specific attributes to control at release.
  • Apply the understanding of structure activity relationships and the principles of quality control gained through the Webinar to biological products undergoing clinical development and market authorisation

There will be a Q&A session.

Pricing

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

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When
08/12/2022 12:00 - 13:00
Where
ONLINE
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