Michael Lee with experience in the area of biopharmaceutical / pharmaceutical manufacturing covers plant operations & new facility projects.  He is currently the Senior VP at Mab Venture for Bio MFG & New Facility Projects.

Michael’s prior job was the Project Director of BeiGene for the new biomanufacturing facility in GuangZhou.  He was the Plant Director of JHL Biotech before joining BeiGene. JHL was the first GE KUBio Modular Bio-Facility Project in the world.

He was VP of new facility project and manufacturing at Shanghai Biomabs, a leading monoclonal antibody development & manufacturing company in China. He also served as Plant Director at Merial, GSK, Roche, and Boehringer Ingelheim.

Michael Lee’s experience in the area of biopharmaceutical / pharmaceutical manufacturing covers plant operations & new facility projects. Michael also serves at ISPE China for its technical committee & training committee.

He also held senior technical positions as Plant Director/Project Director at GSK, Roche, Merial and Boehringer Ingelheim. Merial was a joint venture by Sanofi & Merck and is currently a part of Boehringer Ingelheim.

He was involved in establishing Shanghai Roche facilities in China. His experience in leading the capital investment projects of establishing new biopharmaceutical facilities covers vaccines and monoclonal antibodies in China for sites at various locations.

QA System for Biologics

Quality by Design (QbD): a systematic approach to development that begins with predefined objectives and emphasizes biological product/biomanufacturing process understanding and process control based on sound science and quality risk management. Biologics are one of the fastest-growing segments of the pharmaceutical industry. These drugs, often antibodies or other proteins, are being used to treat cancer, arthritis, and many other diseases. Monitoring the quality of these drugs has proven challenging, because protein production by living cells is much more difficult to control than the synthesis of traditional drugs. Cell Banking system: Two-tiered system: MCB & WCB. Characterization and testing for Identity & Purity. Developing a cost-effective, risk-managed QA/QC strategy for products. Handling biosafety, potency, and impurity profile issues for biologics. Setting appropriate and meaningful product specifications. Managing biomanufacturing process changes. Meeting regulatory expectations for the role of Quality Systems.