Dr. Wei-Kuang Chi, VP at Development Center for Biotechnology
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 24 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 DCB’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 Asia-Pacific clients on process
development leading to GMP productions for recombinant
proteins and monoclonal antibodies. The DCB CGMP BPPF has
recently received Best CMO award on March 29, 2011.