Dr Wei-Kuang Chi, Vice President , Development Center for Biotechnology (DCB), Taiwan will be speaking at Biologic Manufacturing World Asia 2012, part of a series of conferences in the 5th Annual BioPharma Asia Convention 2012, held on 19-22 March at Marina Bay Sands, Singapore.
Dr. Wei-Kuang Chi, Vice President and Director of CGMP Biopharmaceutical Pilot Plant Facility, Development Center for Biotechnology (DCB) obtained his M.S in Engineering and Ph.D. in Chemical Engineering from the University of Pennsylvania, Philadelphia, USA. Dr. Chi has over 21 years of experience in biotechnology process development, including mammalian cell culture (CHO, NS0, hybridoma, 293 cell, insect cell etc.), recombinant yeast (Saccharomyces cerevisiae, and Pichia pastoris ), recombinant Escherichia coli, online mass spectrometric off-gas analysis for fed-batch process control, and cell disruption bioseparation technology. He is responsible for the establishment of DCBÂ’s new multi-product CGMP Biopharmaceutical Pilot Plant Facility (BPPF), including design, equipment procurement/installation, validation, GMP quality system setup, analytical method validation, cleaning validation, process validation, and GMP production. This facility CGMP certified by Taiwan Department of Health (DOH) on December 2005 and received DMF with USA FDA on March 2006. The CGMP Biopharmaceutical Pilot Plant Facility has joined Boehringer Ingelheim Biopharmaceuticals Production Alliance Network since May 2007. This CGMP facility has been used to conduct bioprocess scale-up/development and to produce clinical trial material for protein drugs (monoclonal antibodies, recombinant proteins), at least five products have been produced under GMP for IND submissions for Phase I/II clinical trials, has received four IND approvals from US FDA, Canadian health authority and Taiwan Department of Health. There are also over ten ongoing projects from US and domestic clients on process development leading to GMP productions for recombinant proteins and monoclonal antibodies.
Dr Wei-Kuang Chi will be participating in the following panel discussion:
Panel Discussion: Growth opportunities for biologics manufacturing industry in Asia: Will Asia complement or replace their western counterparts?
1. The opportunities and challenges in the biologics manufacturing space for Asia
2. Harmonizing the EMEA, FDA and SFDA requirements for facility design and driving down operational costs through disposable technology
3. Pharmas' and CMOs' perspective of the biologics manufacturing capabilities in Asia