June 1, 2012
As the biopharmaceutical industry in China continues to grow, the corresponding demand for high-quality, tactical information and proven strategies continues to increase. Although many people see China’s current technologies and skillsets as lagging behind those of more advanced counterparts in North America, Europe, and Asia, the Chinese industry’s thirst for knowledge and eagerness to adopt and adapt new techniques have enabled it to leap-frog development at an astonishing speed.
At IBC’s fourth annual BioProcess International China event, the goal is to bring China and the rest of the world together to explore gaps in development and help bring China up to speed on critical topics such as cell-line engineering, culture media development, analytical characterization strategies (to establish similarity between biosimilar and originator drugs), and design of multiproduct facilities with implementation of single-use systems.
Meet experts from both Europe and the United States who have proven success stories. Gain access to international service providers. Participate in facilitated networking events. And learn tactical strategies for informed decision making.
This conference brings together global leaders who provide you with proven scientific and technical strategies and innovations for the following tracks:
Cell Line Engineering, Cell Culture, and Media Development
Analytical Characterization, Comparability, and Quality Assessment
Downstream Processing and Viral Safety
Single-Use Systems and Multiproduct Facilities
Biosimilars Development (Regulatory and Market Challenges)
Keynote Presentations
“Continuous Bioprocessing for Production of Recombinant Proteins and Monoclonal Antibodies,” by Weichang Zhou (senior director of commercial cell culture development at Genzyme, a Sanofi Company)
“Comparability vs. Similarity for Biosimilarity Assessment: Challenges and Opportunities in US FDA Biosimilar Guidance,” by Earl Dye (director of technical regulatory policy and strategy at Genentech, Inc.)
“Opportunities and Challenges for the Development of Biosimilar Monoclonal Antibodies in Europe,” by Sandy Eisen, chief medical officer of Frontline Pharma Consulting Ltd.)
New This Year
Pfizer will explore innovative solutions to streamline cell culture development platform processes. Henlius Biopharmaceuticals will share its strategy from cell-line development to filing an investigational new drug (IND) application for a biosimilar in under two years. Genentech will take on comparability assessment for clinical development and postapproval chemistry, manufacturing, and controls (CMC) changes. Novartis will compare high-pressure liquid chromatography (HPLC), capillary electrophoresis (CE), mass spectrometry, nuclear magnetic resonance (NMR) imaging, and other analytical technologies for characterizing biological products. Phage Pharmaceuticals will detail the design of a multiproduct, multiphase, and multiuser current good manufacturing practice (CGMP) compliant facility. Biocon India will outline a low-risk, flexible plant approach using single-use systems.
Don’t miss this opportunity to witness and partake in China’s phenomenal growth. Get insider information and proven strategies to help increase yields and improve product quality while ensuring efficiency of production and reducing manufacturing cost.
BioProcess Internationalmagazine subscribers: Save 20% off the standard rates. Register with priority code R12202BPIFE. You may register online or by calling 65-6508-2401.
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