Ching-I Chen Email and Phone Number
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Over 30 years of industrial and laboratory research experience in cell culture/fermentation with extensive hands-on and supervisory experience in process development and scale-up. Complete and comprehensive experience in phase 1 through phase 3 clinical productions and pre-BLA CMC documentations.Specialties: 1) Gene therapy product, therapeutic protein, plasmid DNA vaccine process development and productions.2) Perfusion, Fed-batch, and Batch cell culture processes.3) Mammalian cell (human cell lines, dog cell lines, hybridomas), microbial (bacteria, yeast, filamentous fungi), and insect-cell/baculovirus fermentations.4) Bioreactor process design and scale-up.5) Management of group/team (BS, MS, PhD) and projects.6) Management of CMO's.7) cGMP manufacture and FDA filing (CMC) for various phases of clinical productions.8) GLP study - production of qualified pre-clinical material and qualification of cell-based assay for GLP study.
Independent Consultant
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Independent ConsultantIndependent Consultant Dec 2019 - PresentLondon, GbConsulting services on process development, optimization and manufacturing for gene therapy viral product, recombinant protein therapeutic or plasmid DNA vaccine product from phase 1 through phase 3 clinical productions, process validation, equipment and software validations, and CMC FDA filing. Provided consulting services to various pharmaceutical companies on viral vector production and plasmid DNA vaccine production, and their CMC.
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Senior Director, Process Development And ManufacturingTocagen Inc Jun 2008 - Dec 2019Human cell culture process development producing gene-therapy vector product (retroviral vectors) as brain cancer therapeutic, perfusion bioreactor continuous production, automation, purification, scale-up (1000L), cGMP manufacturing at 2 CMO’s for phase1 to phase 3 clinical materials, tech transfer, late phase and pre-BLA CMC documentation (process pre-qualification, equipment/software validation, risk assessment, FMEA, PJR and PPQ). Key writer for CMC and participation in FDA meeting.
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Senior Manager, Process Development Dept.Mannkind Corporation Jun 2002 - Oct 2007Danbury, Ct, UsLed cell culture/fermentation process and purification developments for company’s plasmid DNA gene therapy products as cancer vaccines, and supported company file two IND’s. Mammalian cell, insect cell, Pichia, and E. coli fermentations, purification of biologics, scale-up, cGMP manufacturing, CMC and GLP study. -
Senior Fermentation ScientistAgraquest, Inc. Nov 2000 - Jun 2002Production of environmentally friendly bio-pesticide and bio-fungicide by Bacillus and by Streptomyces at commercial-scale fermentation, manufacturing equipment evaluation/qualification, and CMC
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ConsultantCytoculture Oct 1999 - Jun 2000Developed cost-effective culturing method to grow an MTBE-degrading bacterium for environmental contamination cleanup
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Bioprocess Development EngineerLawrence Livermore National Laboratory Sep 1993 - Sep 1999Livermore, Ca, UsBioremediation development, gene-therapy enzyme large-scale production by E. coli, Saccharomyces cerevisiae
Ching-I Chen Skills
Ching-I Chen Education Details
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University Of California, DavisMicrobiology (Specialty In Biochemical Engineering)
Frequently Asked Questions about Ching-I Chen
What company does Ching-I Chen work for?
Ching-I Chen works for Independent Consultant
What is Ching-I Chen's role at the current company?
Ching-I Chen's current role is Independent consultant on process development, optimization and manufacturing of biological therapeutics and their CMC..
What is Ching-I Chen's email address?
Ching-I Chen's email address is ch****@****hoo.com
What is Ching-I Chen's direct phone number?
Ching-I Chen's direct phone number is +185841*****
What schools did Ching-I Chen attend?
Ching-I Chen attended University Of California, Davis.
What skills is Ching-I Chen known for?
Ching-I Chen has skills like Purification, Cell, Gmp, Cell Culture, Fermentation, Mammalian Cell Culture, Glp, Protein Chemistry, Biotechnology, Assay Development, Laboratory, Microbiology.
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