Abstract. As part of the GBC (Global Bioanalysis Consortium), the L3 assay format team has focused on reviewing common platforms used to support ligand binding assays in the detection of biotherapeutics.The following review is an overview of discussions and presentations from around the globe with a group of experts from different companies to allow an international harmonization of common practices and suggestions for different platforms. Some of the major platforms include Gyrolab, Erenna, RIA, AlphaLISA, Delfia, Immuno-PCR, Luminex, BIAcore, and ELISAs. The review is meant to support bioanalysts in taking decisions between different platforms depending on the needs of the analyte with a number of recommendations to help integration of platforms into a GLP environment.
The American Association of Pharmaceutical Scientists (AAPS) is an international forum for the exchange of knowledge among scientists to enhance their contributions to drug development. The annual National Biotechnology Conference, organized by the AAPS on 21-23 May 2012 in San Diego, CA, USA, brings together experts from various disciplines representing private industry, academia and governing institutions dedicated toward advancing the scientific and technological progress related to discovery, development and manufacture of medical biotechnology products. Over 300 scientific poster presentations and approximately 50 oral presentation and discussion sessions examined a breadth of topics pertaining to biotechnology drug development, such as the advancement of vaccines and biosimilars, emerging and innovative technologies, nonclinical and clinical bioanalysis, and regulatory updates. This conference report highlights the existing challenges with ligand-binding assays, emerging challenges, innovative integration of various technology platforms and applicable regulatory considerations as they relate to immunogenicity and pharmacokinetic bioanalytical assessments.
The American Association of Pharmaceutical Scientists is a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to drug development. The annual National Biotechnology Conference, conducted and organized by the American Association of Pharmaceutical Scientists, is a forum dedicated to advancements in science and technology related to discovery, development and manufacture of medical biotechnology products. The 2011 National Biotechnology Conference meeting convened in San Francisco, CA, USA on 16-18 May. Over 300 abstracts were submitted and approximately 50 sessions examined topics pertaining to advances in drug development, emerging analytical technologies, bioanalysis-related issues, biosimilar therapies, updates on global regulatory documents and expectations, and other topics. The focus of this article is to highlight key developments relevant to immunogenicity and pharmacokinetic drug concentration bioanalysis.
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