Organized by CASSS, an International Separation Science Society, the seventh annual CMC Strategy Forum Europe will focus on improving quality in development and manufacturing of biopharmaceutical products. Led by experts from global regulatory agencies, academia, and industry, this event series explores emerging aspects of chemistry, manufacturing, and controls (CMC) technology and regulation. The forums are designed to maximize dialog among participants. Relatively short and focused presentations set the agenda for panel discussions that engage all who have experience and expertise to share.

Monday, 6 May 2013

The morning workshop on process validation is sponsored by European Biopharmaceutical Enterprises (EBE), an organization that represents biopharmaceutical companies operating in Europe. The afternoon session covers industry modernization with a regulatory perspectives plenary session.

Tuesday, 7 May 2013

Morning Session — Beyond Specifications (chaired by Brendan Hughes and Karin Sewerin): Specifications constitute a well-established and understood mechanism for assessing the quality of materials, intermediates, drug substances, and drug products. Tests and limits can be applied based on prior knowledge, clinical experience, and process capability. But testing strategies are not always integrated with input materials and process controls, and opportunities for advanced control aren’t always taken. Developments have been made in understanding the role that process control can play in determining the ultimate quality of a product. Multifactor, multicomponent control strategies have evolved. This session will explore their establishment, evolution, and life-cycle management for biotech products.

Afternoon Session — Scope and Limitations of Bioassays (chaired by Thomas Schreitmüller and Lance Smallshaw): Based on measuring physiological responses in animals or cellular responses in cells, the potency of a biotherapeutic product can be determined using bioassays. Potency bioassays are often the most complex items in a drug substance and drug product control system. Given their complexities, such bioassays are often associated with higher analytical variability than physicochemical testing methods and thus require a considerable development, validation, and maintenance. Sponsors have begun abandoning animal-based potency assays and are focusing instead on cell- or receptor-based systems. Today’s assay formats and reagents are pushed to higher precision and throughput, with engineered cell lines and label-free receptor-binding assays. This session will discuss the latest developments and associated challenges, industry and regulatory viewpoints, and considerations for product life-cycles.

Late-Afternoon Session — QbD from Concept to Implementation (chaired by Martin Schiestl and Paul Varley): Quality by design (QbD) is in essence a systematic and risk-based approach for process development and manufacturing. Using principles and tools described in ICH Q8–Q11, industry and regulators are collecting implementation experiences. Pilot review programs are ongoing at the regulatory agencies as the industry uses QbD in development more and more. But it is not an all-or-nothing approach. Based on submitted case studies and lessons learned, this session will highlight and discuss current experiences so far.

Wednesday, 8 May 2013

Morning Session — Devices, Combination Products, and Related Issues for Drug Products (chaired by Ralf Gleixner and Inger Mollerup): Regulatory requirements for drug product devices are being intensified globally — particularly in the United States and the European Union. This session will overview the latest regulatory framework and upcoming guidance from both EMA and FDA points of view and offer lessons learned from practical industry case studies.

Afternoon Session — Change Management Protocols (chaired by Jason Hampson and Jolanda Westerlaken): Europe introduced its Change Management Protocol (CMP) in 2010; the US Comparability Protocol (CP) has been in place since 2003. Recent developments in the latter include an expanded protocol and an ability to submit protocols for multiple products. Pharmaceutical companies are using these procedures to shorten approval periods for manufacturing changes. This session will discuss industry experience to date with both US and EU procedures through several case studies. Agency perspectives will also be presented. A panel discussion will further examine the benefits, challenges, and limitations of these procedures as well as potential opportunities for further refinement.

For More Information

For program updates, registration, or hotel information, browse the forum website. You may also contact forum manager Karen A. Bertani, CMP at 1-510-428-0740, fax 1-510-428-0741, or [email protected].