The Fifth Session of U.S. Pharmacopeial Bioassay Convention

 

 Why

This convention will gather Biopharmaceutical/biotechnology industry professionals, Biopharmaceutical development scientists, Pharmaceutical industry professionals, Regulatory experts for biologics, Biosimilar manufacturers, Bioassay practitioners and software experts, Biostatisticians, Analytical development scientists and QA/QC specialists for biologics. Beyond general bioassay guidance, the workshop will focus on assay-specific or product-specific challenges, the reagents and standards necessary to derive reliable potency results, and modern software aids that are common tools in the bioassay laboratory. People can register now on its official website.

 Introduction

Biologics-particularly more modern ones such as recombinant proteins and monoclonal antibodies are larger and more complex in their makeup, and are derived from living cells or organisms. As a result, it is not possible to fully characterize biologic drugs in the same way that chemical drugs are characterized using commonly-applied analytical techniques and procedures. Bioassays are used to assign or confirm drug potency and to validate that a drug is functioning as expected, usually by comparison to a known reference standard. The 5th Bioassay Workshop is built on past USP workshops and focused on the use of bioassay data sets and case studies to address compliance challenges.

 Topics

 

• Life Cycle Management with <1032>, <1033>, and <1034>
• Assay-Specific Case Studies
• Life Cycle Management of Reference Standards and Critical Reagents in Potency Bioassays
• Application of New Technologies to the Field of Bioassays
• Demonstrations and Discussion Sessions with Software Vendors

 

 When

December 4-5, 2012

 Where

U.S. Pharmacopeial (USP) Headquarters, Meetings Center
12601 Twinbrook Parkway
Rockville, MD, 20852 USA