Hui Xiang

-Lead process characterization for neurotoxin drug substance manufacturing processes -Lead purification development supporting early evaluation of neurotoxin drug candidates -Lead toxin analytics project to gain better understanding of neurotoxin drug substances Astound Award for successful tech transfer and Phase 3 production, one pending publication, three patent applications

-Provided scientific and technical leadership in process development and manufacturing support of 1) commercial production of BOTOX drug substance 2) clinical production of improved neurotoxin drug substances (Phase II/III) -Led risk assessment, technology transfer, process improvement, process characterization, and process validation -Authored study protocols/reports, supported CMC sections of IND/IMPD/BLA and response to agency questions -Supported manufacturing, quality, and regulatory functions as needed -Supported Legal to defend Allergan IP against competitor claims Awards for Excellence, publications

-Improved formulation process for siRNA liposome products -Selected and managed CMOs for Phase 1/2 clinical manufacturing of siRNA liposome products -Supported budget forecast and management -Mentored direct reports and co-workers on QbD development

-Developed the first chromatography-based animal-product-free production process of botulinum toxin type A complex, which was granted world-wide patents -Further developed and characterized two high profile products using QbD approach (improved toxin products) -Supported the commercial BOTOX drug substance manufacturing process (risk assessment, post-approval process changes, viral safety strategy, process characterization and improvement, statistical analysis, technical support on regulatory filing and response regarding CMC issues) -Provided technical advice to a Korean partner in process development and clinical manufacturing of botulinum toxin type A complex -Led and mentored a highly productive process development group (2005 – 2013) Certificate of Special Recognition on Creative R & D Contributions, Worldwide Patents on Animal-product-free Production Process of BoNT/A Complex, Allergan Records of Invention, Awards for Excellence

-Developed and optimized procedures for protein purification and scale-up supporting drug discovery Awards for Excellence, publication

-Optimized purification process for IgG cytokine fusion protein for Phase III manufacturing -Developed purification processes for monoclonal IgM from mammalian cell culture and human lactoferrin from transgenic milk -Executed viral clearance studies for different purification processes

-Purified over a hundred recombinant proteins and synthetic peptides for NMR studies supporting drug discovery. Optimized expression conditions for isotope labeling. Characterized purified proteins/peptides using various analytical techniques. Trained guest workers/co-op students. Assisted laboratory administration.