World BioProcess Leaders China Summit 2016

World BioProcess Leaders China summit provides you with practical tools, technologies and strategies to drive efficiencies in your process development and biomanufacturing activities so you can accelerate your biologics to commercialization. Benefit from multiple case studies and industry experts who will share strategies to save you time and money while reducing the development timeline from IND to market.

You will learn how to navigate the CMC studies and regulatory challenges of biological products developed in China and compare requirements from the CFDA and US FDA. You will also learn about new approaches for upstream and downstream development, biomanufacturing facility readiness, analytical and quality control for a wide-range of biotherapeutics including ADCs, bispecifics, next-generation mAbs and biosimilars.

No other conference in China provides a more comprehensive update of the technical, scientific and strategic innovations across all phases of bioprocess development.

With over 40 speakers and estimation to bring over 180 Biopharma professionals, the key congress topics will cover:

• Upstream: Cell Line and Cell Culture Processing

• Downstream: Recovery, Purification and Viral Safety/Clearance

• Navigating Regulatory Interactions with CFDA and US FDA

• Portfolio Updates on Innovative Biologics R&D in China

• Analytical Methods and Formulation Strategies and Technologies

• Quality Control, Quality Assurance and QbD

• Biomanufacturing, Facility Readiness and GMP Compliance

• Biosimilars: Regulatory Experiences and Risk-based Strategies