Date: 22 May 2019
Time: 12:00–13:00 BST

The ABC Biologics webinar series from TOPRA’s Biotech Spin is designed to introduce topics important to the development 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

Speakers and topics

• Cecil Nick, Vice President (Technical) with PAREXEL, will speak on the elements of production and structure of biologicals that impact their quality.
• Rhydian Howells, Associate Director Regulatory Affairs with Diamond Pharma Services, 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.