Literature DB >> 23425268

Conference Report: Bioanalysis-related topics presented at the International Conference and Exhibition on Biowaivers and Biosimilars.

Kelly S Colletti1.   

Abstract

This conference of approximately 30 professionals attracted a diverse group of attendees, whose expertise spanned the broad topics of development, production, testing and regulation of biosimilars. The topics covered during this meeting were varied in scope due to the breadth of knowledge of the attendees. Topics of discussion included: biowaivers for small molecules; patent law and interpretation of the Biologics Price Competition and Innovation Act; analytical tools for the characterization of a biosimilar; novel production methods; bioanalytical methods; immunogenicity considerations; formulation techniques; and the characterization of the glycosylation of biosimilars.

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Year:  2013        PMID: 23425268     DOI: 10.4155/bio.12.330

Source DB:  PubMed          Journal:  Bioanalysis        ISSN: 1757-6180            Impact factor:   2.681


  1 in total

1.  Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs.

Authors:  Alex Colbert; Amber Umble-Romero; Samantha Prokop; Vincent Fung-Sing Chow; Teresa Wong; Danielle DeSimone; Lei Zhou; Susan Pederson
Journal:  MAbs       Date:  2014       Impact factor: 5.857

  1 in total

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