The Biotech, Cell & Gene Therapies Steering Group is pleased to present this technical webinar exploring the elements involved in delivering quality in the production of biologicals.
Date: Wednesday 27 February 2025
Time: 14:00 - 15:00 GMT / 15:00 - 16:00 CET
Duration: 1 hour
Webinar Overview:
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.
Presenters:
Cecil Nick, Vice President (Technical), Parexel
Cecil has been working in regulatory affairs and clinical development for over 30 years with particular expertise in monoclonals and biosimilars; his last 25 years have focused on biological medicines. Cecil’s areas of expertise include: oncology, inflammatory disease, diabetes, growth factors, multiple sclerosis, neurology, antivirals, blood products and vaccines.
Cecil will speak on the elements of production and structure of biologicals that impact their quality.
Rhydian Howells, Vice President Regulatory CMC, ProPharma.
Rhydian has worked in the development of large complex biologicals for over 20 years. Rhydian started his career at a leading CDMO supporting the analytical development of innovator and biosimilar molecules. He then transitioned to Regulatory CMC roles and has supported the clinical development, approval and commercialisation of many products covering Cell and Gene Therapy and recombinant proteins including mAbs.
Rhydian 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.
Pricing
Members: Free
Non-members: £45