Home > WCBP

THE NEXT WCBP MEETING January 29-31, 2007 Washinton, DC, USA WCBP 2007: 11th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products Renaissance Mayflower Hotel ABSTRACT SUBMISSION DEADLINE: October 13, 2006 for consideration for oral presentation December 13, 2006 for poster presentation More Information Submit Abstract Online REGISTER ONLINE  October 13, 2006 Abstract deadline to be considered for oral presentation. December 13, 2006 Abstract deadline to be considered for poster presentation. Early Bird Registration Extended January 5, 2006 Early Bird Registration ends January 19, 2006 Online Registration Closes January 28-31, 2007 On Site Registration Monday, January 29, 2007 7:00 - 10:00 PM Welcome Reception Women's Memorial Museum SPONSORS & EXHIBITORS December 20, 2006 Deadline for Submitted Ad Copy

About WCBP

The WCBP (Well Chararacterized Biotechnology Pharmaceutical) meeting is the pre-eminent conference addressing the analytical development/regulatory control interface for biotechnology derived health intervention products. The goal of this Symposium series is to provide a forum for discussing the latest bioanalytical methods and their practical application to biotechnology pharmaceuticals and other health related products. Both state-of-the-art innovations as well as conventional technologies addressing research and routine testing applications will be covered. This includes both method and instrumental advances that are used for product characterization, process development, in-process analysis and validate release & stability testing.

What is a “Well Characterized Biotechnology Pharmaceutical” (WCBP)?

Founded on the robust drug development database provided by sectors of the biotech industry, the US FDA Center for Biologics Evaluation and Research (CBER) coined the term “Well Characterized Biotechnology Pharmaceutical” for their 1996 symposium “Characterization of Biotechnology Pharmaceutical Products.” Both the advances in analytical biotechnology and the limitations of the available methodologies were discussed, serving as a basis for improving the regulation of biotechnology products.

Prior to 1996, CBER required for product approval both a Product License Agreement (PLA) and an Establishment License Agreement (ELA). The ELA was specific to the facility and process used for that product and prohibited unapproved process fluctuations. For the often very complex and frequently poorly characterized biological products (e.g. vaccines and blood products) the controlled process and facility constraints of the PLA/ELA combination helped ensure the reproducible manufacture of safe and efficacious biologic products.

Both the advent of recombinant gene technology to enable large scale, purified protein manufacture and the development of modern analytical technology to characterize molecular diversity, has facilitated the regulatory evolution of the WCBP concept. When a protein pharmaceutical was “well characterized”, the natural molecular heterogeneity, impurity profile, and potency could be defined with a high degree of confidence. From those discussions in 1996, CBER developed a new approval mode, the Biological License Application (BLA), which places primary emphasis on the detailed analytical characterization of the molecular entity (well characterized) as a means of establishing a reproducible manufacture of the biological pharmaceutical. Nevertheless, the manufacturing process and its inherent critical controls are still addressed, remaining paramount in importance and intrinsically tied to the product. For licensed biotech pharmaceuticals, changes to an existing process may be approved without additional clinical efficacy trials via “comparability protocols”. Although the term “well characterized biological” has been abandoned, having evolved into “specified biological”, the symposium organizing committee has kept the WCBP acronym as a reference to how state of the art bioanalytical methodology drives the evolution of new regulatory policy.

Conference History