New Webinar Announcement - Biosimilar Characterization: Leveraging Protein Analytical Technology Within GMP Guidelines to Design a Pathway to a Successful Product

The SelectScience Editors are pleased to announce a complimentary, live educational webinar entitled “Biosimilar Characterization: Leveraging Protein Analytical Technology Within GMP Guidelines to Design a Pathway to a Successful Product” featuring guest speakers Dr. Sian Estdale, Manager of Protein Chemistry Services, Covance and Dr. Scott Berger, Snr. Marketing Manager, Biopharmaceutical Solutions, Waters Corporation.

Learn about the advantages of using QTof MS data for the characterization of a biosimilar candidate, to meet the standards of regulatory bodies such as the U.S.FDA and EMA, through case study examples.

Biopharmaceutical characterization requires: Confirming primary sequence through to identifying post-translational modifications (PTMs) in glycosylation, establishing biophysical and functional comparability for the innovator and candidate biosimilar, and performing studies that establish expected variation within an innovator biotherapeutic.

Time-of-flight mass spectrometry (Tof MS, or QTof MS) analysis of biosimilars offers:
• Biophysical and functional comparability and variability knowledge.
• Early knowledge of the target drug, to support late phase studies.
• Streamlined workflows, making rich characterization assays routine.
• Reduced analytical burden when manufacturing safe and effective products.

Dr. Michelle Maxwell, Drug Discovery & Development Editor at SelectScience, will be hosting the webinar which will be followed by a live Q&A session. A certificate of attendance can be provided upon request.

Webinar Information:

Date: Thursday 17th September 2013

Time: 5:00pm CEST / 4:00pm BST / 11:00am EDT / 8:00am PDT

Click here to check the time of the webinar in your country

Duration: 45 minute discussion, followed by a 15 minute live Q&A

Click here to learn more and/or register for this educational webinar