Dr. Frank Ho has been working in the biotechnology industry since 1992 after spending 10 years in the academia. His industry experience has been in the areas of biologic process development (PD), manufacturing (MFG), and contract manufacturing (CMO) with the increasing responsibility at several prestigious biotech companies mainly in the San Francisco Bay Area, and a few in Asia. He is now working as bioprocess consultant advising several early and late stage programs, and facility design in the US. His complementary technical development and GMP operational experience covers upstream, downstream and analytical for both innovative and biosimilar medicines. He has accomplished 12 US FDA, 2 EU, 1 TW and 1 JP approved biologics, including polypeptides, fusion proteins, pegylated biologics, mAbs, and therapeutic enzymes. He has led or supported more than 50 internal strategic pipelines to GMP manufacturing for various clinical phase and commercialization (ex: aldurazyme, naglazyme, Vimizim, Palynziq, Besremi, Herwenda).He also has extensive worldwide outsourcing CMO expertise in leading and transferring several US programs to Europe, Asia and North America as process donor, and he also held positions worked as CDMOs in Asia as process receiver, responsible for leading expression system and media platform development, up/downstream PD, tech transfer and microbial/mammalian GMP plant operations. He managed and served more than 20 clients' projects varying from tox, IND-enabling to phase 3/validation, and one marketed biologic manufacturing site transfer and approval. In addition to his biologics technical expertise, he held positions in responsible for various manufacturing facility design, start-up and operation in the US and overseas (ex: China, Singapore and Taiwan) ranging from 500L to multi 2000L capacity. He is well versed in GMP cleanroom and bioprocess equipment design and IOPQ, he has led commissioning several large scale fermentors, disposable bioreactors, various mixing/heating/pegylation vessels, recovery/disc stack centrifuge/homogenizer and chromatography skids for GMP manufacturing capability.He is experienced in managing as the head of scientific process division comprising RA, Scientist, Dir and VP, and/or as the head of cGMP plant operation including Facility and Supply Chain with the team of 80+ FTEs, Specialties: Biologics technical operation, process development, characterization and validation. Technology transfer, contract manufacturing and GMP manufacturing operation, facility design and qualification.