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Cambridge Healthtech Institute presents a three-part conference focusing on advances in analytical characterization and bioassays at the Hyatt Regency Baltimore, Baltimore MD.

Starts

Mar 09, 2015

Ends

Mar 13, 2015

Location

Baltimore, United States

Cambridge Healthtech Institute presents the Sixth Annual Biotherapeutics Analytical Summit.  This event features 200+ industry, regulatory, and biosimilar professionals gaining insight into analytical characterization and comparability for change implementation through case studies, interactive break-out discussions, networking opportunities and more. The event takes place at the Hyatt Regency, Baltimore MD. 

 

Speakers:  

Dr. Berangere Tissot, SGS' Technical Client Manager will be presenting Analysis of O-glycosylation – Case studies on Tuesday, March 10 at 12:05pm

Amongst the tools to characterize protein glycosylation, the toolkit for O-glycosylation is not as diverse and not as extensive as the one for N-glycans. Case studies of O-glycan characterization will be presented.

Dr. Fiona Greer, SGS' Global Director, Biopharma Services Development will be presenting Primary and Higher Order Structural Characterization Strategies for Biosimilarity Assessment on Thursday, March 12 at 10:05am

Biosimilar development requires comprehensive physicochemical characterization at many stages. Initially, intensive characterization of multiple originator batches determines variability of the target quality attributes for the biosimilar. Subsequently, side-by side comparison is carried out with the originator to demonstrate “Biosimilarity”. Strategies for comparability will be discussed particularly for antibodies where their size and complexity requires orthogonal approaches.

 

Round Tables:

Dr. Berangere Tissot will be co-hosting Table 3: Analytical Strategies For Comparability with Dr. Thomas Lerch, Senior Scientist, Analytical R&D at Pfizer, on March 12 at 4:15pm.

  • What are the key strategic differences between comparability and biosimilarity exercises?

  • What is the right assay for a given process change?

  • What are the similarity criteria for non-quantitative assays?

Dr. Inigo Rodriguez-Mendieta will be co-hosting Table 1: Biologics Higher Order Structure Analysis Technologies with Dr. Xing Wang, President, R&D, Array Bridge, Inc. on March 12 at 4:15pm

  • What are the technologies out there for Biologics Higher Order Structure Analysis?

  • Is there a gap between required HOS characterization and what the technologies can offer?

  • Can we define an HOS impurity profile?

  • How to link HOS impurity to immunogenicity and other properties of Biologics?