Advanced process development using automated micro bioreactors shortens timelines and provides process solutions for a rapid scale up

Presented by Dr. Jincai Li, Vice President of WuXi Biologics

Dr. Jincai (Jimmy) Li is currently Vice President of WuXi Biologics.  Dr. Li has over 17 years’ experience in Biologics process development, scale-up and cGMP manufacturing.  His group contributed to over 40 IND submissions, both in and outside of China, as well as BLA submission works.   Dr. Li joined WuXi Biologics in 2011, helped built and led the Cell Culture Process Development & pilot plant production group, and then managed the cGMP Drug Substance manufacturing facility. Before joining WuXi Biologics, Dr. Li was a cell culture process development Group Leader at Genentech Inc.  Before that, Dr. Li also worked at Tanox, Inc, where he led the manufacturing sciences group supporting PhIII production of a mAb product, and at Diversa Corporation (now BASF), in charge of process development for multiple recombinant enzyme projects. Dr. Li holds B.S. degree from Tsinghua University, and Ph.D. degree from University of Maryland Baltimore County, majoring in Chemical and Biochemical Engineering.
Liang Tang, PhD, Vice President of WuXi Biologics
Dr. Liang Tang is currently working at WuXi Biologics as a Vice President of Biologics Development and Manufacturing. Apart from leading Cell Culture Process Development function in project delivery and new technology development, Dr. Tang also serves as a CMC leader and provide leadership in development and manufacturing alliance management, product development and manufacturing strategy for selected projects. Dr. Tang was trained in protein biochemistry and molecular biology from McGill University, Canada and had postdoc training at the Biochemistry Department, Imperial College of Science, Technology and Medicine, in London, UK. Before joining WuXi Biologics, Dr. Tang worked as a function head of Molecular Biology, Cell Culture and Protein Expression for Bayer US at San Francisco, USA. He worked over 14+ years at Bayer Pharmaceutical participating in many protein therapeutic projects in CMC, supporting Bayer protein therapeutic products in the market, such as GamunexTM, Kogenate® FS and BETASERON®, and also actively involved in the research of novel protein therapeutics in hematology and ophthalmology supporting the Bayer biologic therapeutic pipeline.
 
Sponsored by

 
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2016, the company employed approx. 4,700 people, and earned sales revenue of 1,052 million euros.
 
ambr: a platform for small-scale screening, development and characterisation of cell culture and microbial fermentation
In the last eight years, the ambr platform has developed into a significant component of the toolset used by the biopharmaceutical industry for a wide range of upstream activities.  The small-scale, high throughput nature of the systems coupled with the associated software functionality enables a many common tasks to be undertaken quickly, easily and reproducibly. These range from early stage screening, through process development and characterisation and the development of scale-down models for trouble-shooting larger scale reactor operations.  This presentation will describe the full range of ambr products, their characteristics and the types of results that have been achieve with these products as well as recent developments that have served to enhance the utility of the ambr portfolio.
Presented by Sunil Chhatre, Sartorius Stedim Biotech
Sunil Chhatre has been a bioprocess product specialist at Sartorius for over six years, providing technical application support across the full range of cell culture and microbial fermentation products within the ambr 15 and 250 portfolio.  In this role he has conducted many pre-sales trials and post-sales training at a wide range of commercial organisations and academic institutions, as well as providing on-site and remote support to a number of other specialists within Sartorius.  His primary focus these days lies on the market in Asia, the Far East and Australasia but additionally he has worked extensively in Europe as well.
Before joining Sartorius, Sunil studied Biochemical Engineering at University College London in the UK where his research focused upon the development of small-scale models for a range of biopharmaceutical operations with a particular emphasis on chromatography.