This course will focus on development and manufacturing activities required to bring a mAb from DNA to DP (drug product) to support a sucessful IND filing. Several options will be discussed on the time it takes to perform these activiites and what activities can be performed in parallel if a faster timeline is required. Typical timelines can range from 12-24 months.
The typical rate limiting step for filing an IND is getting the tox material produced early. HJBís approach is to do parallel development for Cell Line, Upstream, Downstream, and Formulation in order to lock the process before the final clone has been chosen. Once the final clone has been chosen, Tox lot can start immediately. This approach can save 2-3 months from a typical timeline.
- Understand the regulatory requirement for a large molecule CMC package in IND filing
- Understand the overall timeline and key components of CMC development for a novel therapeutic molecule
Van Leang, Ph.D.
Sr Director Global CMC Operations
HJB (Hangzhou) Co., Ltd.
Van Leang is a Sr. Director of Global CMC Operations at HJB Bio, a biologics CDMO. Our companyís mission is to employ cutting-edge technology to reduce cost and timeline for clients as they look to develop, manufacture, and deliver their therapeutic to patients. As Sr. Director Global CMC Operations, Van is responsible for overseeing the entire CMC process to ensure the development, manufacturing, and testing activities meet the clientís timeline. Prior to the current role, Van was head of Purification Process Development group at HJB. Prior to joining HJB in 2018, he was at NGM and Bayer working in downstream development, clinical manufacturing, and CMC technical lead. He has extensive experience in product and CMC development, technology transfer, GMP manufacturing and manufacturing support. Van received his B.S. in Chemical Engineering from University of California - Berkeley and Ph.D. in Chemical Engineering from the University of California - Davis.
Jerry Yang, Ph.D.
GM, CDMO Business Unit
HJB (Hangzhou) Co., Ltd.
Dr. Yang is a seasoned executive in thebiopharmaceutical industry. He is now General Manager of CDMO Business Unit at HJB (Hangzhou), China.
HJB leverages the most innovative and proprietary platform, and combines intensified process development of antibody with highly integrated production flow, modularized factory design, as well as disposable technology to ensure flexible and efficient biologics manufacture. We provide world-class quality CMC development and GMP manufacturing services.
Dr. Yangís distinguished career includes increasing roles in major US biopharmaceutical companies and institutions, include Merck & Co.,Johns Hopkins Medical School as Gene Therapy Facility, Allergan and at Amgen as Director in process and product development. Dr. Yang is well recognized world-wide as a Fellow of the Society for Industrial Microbiology and Biotechnology (SIMB), Senior Editor for the Journal of Industrial Microbiology & Biotechnology, and Advisory Board member for BioProcess International journal.
Cost: No Cost!