Biosimilars Webinar Series

Join Intertek's experts for a free webinar series covering regulatory guidance, bioanalytical and analytical requirements to demonstrate comparability for biosimilar products.

Biologic medicines such as biosimilars and antibody therapeutics present bioanalytical challenges during development. In this webinar series, Intertek experts discuss the key bioanalytical approaches and relevant regulatory issues for successful development during a short series of informative and complementary webinars.

Who should attend? Delegates who would like to know more about these areas
Webinar format: 35-40 minutes of technical presentation followed by a short question and answer session
System requirements: Internet accessible PC with speaker or headset capability
Registration: Please follow the registration links below to receive your joining details

Development and validation of pharmacokinetic (PK) and immunogenicity assays supporting demonstration of biosimilarity
02 June 2016 4:00 PM GMT / 11:00 AM EST / 8:00 AM PST
Speaker: Jeff Thomas, Senior Project Manager, Bioanalytical Immunochemistry Services
For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product. Therefore, pharmacokinetic (PK) and immunogenicity (antidrug antibody, ADA) assays that allow for the demonstration of biosimilarity are critical. There are substantial regulatory guidance documents from both the European Medicines Agency and the FDA on biosimilar drug development, as well as regulatory guidance and extensive publications on PK for biologics in general. This webinar will refer to the guidance documents and highlight the key issues concerned with development and validation of ligand-binding assays (LBAs) to support the PK assessments and immunogenicity assays for biosimilar drug development. 

Registration is now closed however you can access the recording here.

Analytical comparability studies for biosimilars

16 June 2016 4:00 PM BST / 11:00 AM EDT / 8:00:00 AM PDT 

Registration is now closed however you can access the recording here. 

Speaker: Ashleigh Wake, Biopharmaceutical Services Leader, Intertek Pharmaceutical Services
Similar biological medicinal products (biosimilars) must demonstrate, during development, similar quality, efficacy and safety to an existing marketed biologic. Biosimilars are just as complex as the reference biologic and as a result comparability studies include a multitude of orthogonal analytical approaches to assess the physico-chemical properties, structure and biological activity. This webinar will cover a summary of the relevant regulatory guidelines and comparability study analytical approaches used to define product identity, integrity, purity. Bioassays to determine potency or a quantitative measure of the product’s biological activity for quality control will also be discussed.  

Meet our Experts

Jeff Thomas, Senior Project Manager, Bioanalytical Immunochemistry Services
Jeff Thomas is an expert in the field of large molecule Bioanalysis to support Pharmacokinetic, Anti-Drug Antibody, and Neutralizing Antibody assays. He is currently Project Manager at Intertek Pharmaceutical Services in San Diego, an industry leader in Bioanalysis. He has a combined 10 years of industry experience as an analytical immunochemist and laboratory manager. Mr. Thomas has served as Principal Investigator for numerous preclinical studies from a wide range of species, in addition to all phases of clinical studies (from FIH to post-marketed). His strengths include validating difficult assays in rare matrices such as ocular tissues, cerebrospinal fluid, cell extracts, biological fluids, etc. Recently he has co-authored publications on the challenges of developing immunogenicity assays to support biosimilar comparability studies.

Ashleigh Wake, Biopharmaceutical Services Leader, Intertek Pharmaceutical Services

Ashleigh Wake is the Biotechnology Program Manager at Intertek Pharmaceutical Services, Manchester, UK Ashleigh graduated from Huddersfield University (West Yorkshire, England) with a B,Sc. in Analytical Chemistry and joined Zeneca as Biotransformation Chemist followed by technical and operational management roles with AstraZeneca and Syngenta before joining Intertek. With a background in MS and a career of almost two decades as an operational/technical team leader and study director for projects spanning the drug development process (including metabolism, PK studies and API/product characterization, CMC support analytics and ICH stability studies), Ashleigh has specialized in the design and delivery of regulatory (GXP) studies relating to the physiochemical and biological activity of biomolecules. Ashleigh is responsible for the strategic growth and technical direction of Intertek’s GMP compliant centre of excellence for biologics characterization in Manchester, UK. Intertek’s strategy has been to establish a one source solution for protein analysis relating to the requirements of ICH Q6B and biosimilar development.

 
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