The US Pharmacopeial Convention (USP), a non-profit organisation and BioPharmaceutical Emerging Best Practices Association (BEBPA) will be organising a two day workshop titled 'Measurement of Residual Host Cell Protein (HCP) and DNA in Biotechnology Products', on June 3 & 4, 2013 at USP headquarters in Maryland.
The workshop will focus on technological, regulatory and clinical issues related to residual host cell impurities in biotechnology-derived products. It will have detailed presentations from industry, academic, regulatory and pharmacopeial stakeholders covering regulatory considerations and platform approaches for measurement of residual DNA and HCPs; HCP assay and reagent qualification issues; emerging technologies; and pharmacopeial development of best practice standards for measuring residual DNA (US) and HCPs (US and Europe).
Some of the key speakers who will be making presentation at the workshop includes representatives from US Food and Drug Administration, the Paul Ehrlich Institute (Germany), Amgen, Covance, Genentech, Biogen, University of Rhode Island, University of Notre Dame, Waters Corporation, Novartis Pharma AG, Pfizer, and Janssen/Johnson & Johnson etc.
The attendees will also be able to get information from members of USP’s Expert Panels on standards-setting activities related to residual HCP measurement, residual DNA in biotech-derived products and immunological test methods.