Understanding Your Biotech Product – Analytical and Bio-analytical Characterisation

Brochure & booking form

Aim of the Meeting

• To ensure that delegates have the appropriate knowledge in the field of analytical and bio-analytical characterisation to allow them to undertake their professional roles and specifically as follows:
• The techniques used to characterise biopharmaceutical medicinal products
• Regulatory requirements and expectations for characterisation data at different stages of the product development cycle
• Impact of process variables on product quality
• Requirements for comparability assessment following process changes
• Importance of characterisation techniques in a biosimilar product MAA.

Meeting's Programme includes

• Analytical characterisation concentrating on in vitro and biophysical techniques
• Bio-analytical techniques concentrating on bioassays and agency expectations for bioassays
• Impact of process variables on product quality
• Comparability assessment example following a major process change (a case study from Wyeth)
• Regulatory Agency perspective on comparability
• Biosimilars

Speakers include

• Paul Chamberlain, Director, NDA Advisory Board
• Brendan Fish, Director Bio-analytical Group, MedImmune , UK
• Brian Fitzpatrick, Associate Director of Analytical Development, Wyeth
• Stephen Fitzpatrick, Head of CMC RA, UCB Pharma Ltd
• Kowid Ho, Biologicals/Biotechnology Unit, AFSSaPS, France
• Cecil Nick, Vice President, Parexel Consulting , UK
• Jane Robinson, NIBSC, UK