Wei Chen PhD
Biopharmaceutical Development Partner
About
Speed to IND and global market with the best CMC solutions Experience 30 years of pharmaceutical and biopharmaceutical industry experiene in biologic product development I.e mAbs, ADC, gene cell therapies, vaccines, DNA/RNA and cGMP manufacturing operations including cost effective cGMP facility design-build & commissioning, biologic processes optimization & scale up, USFDA/EMEA cGMP site inspections & CMC regulatory submissions. Expertise Synergism BioProduction Technology Integrate key steps into one single synergistic system. It optimizes synergistically from synthetic gene constructs, cell kinetics, metabolic pathways, protein expression, fermentation, purification, formulation, cGMP facility flows to QC testing, QA documentation and the ultimate end point: regulatory submission and approval. Such a system can set records in cost and time savings for Novel biopharmaceuticals, i.e. ADC, bispecific MAb, Vaccines, Biosimilars or Biobetters projects from launch to completion. It can significantly improve regulatory compliance and minimize operational failures. Identification of "Rate Limiting Steps" and Improvement of Biological Processing Efficiencies over 2 Logs. Integrated FLEX Design Systems for Cost-Effective cGMP Facility Commissioning with Operational and FDA Inspection as End Points. Recent activities Oncology ADC MAb, Bi Specific MAb High potency CGMP conjugation facility Biosimilars and Biobetters protein therapeutics BioProcessing, BioManufacturing, Low Cost cGMP Facility Design/Commissioning/Operation, High potency facility design, CMC Regulatory Submissions, cGMP Facility Site Inspections, Business Development, Disruptive BioManufacturing Technology, Targeted Cell Lines Development, Gene Cell Therapy Technology, Viral HBV small molecules, Microbial Immunotherapy, Microbiome, Phage technology, Oncolytic viral therapy
United States
San Diego
Biotechnology
Biopharmaceuticals, Protein Chemistry, Vaccines, Technology Transfer, Pharmaceutical Industry, Monoclonal Antibodies, GMP, Pharmaceutics, Clinical Development, Microbiology, Fermentation Process Development, IND, GxP, Cell Culture, Analytical Method Validation, Regulatory Submissions, Protein Expression, Purification, Validation, Oncology
Experience
Biopharmaceutical Development Partner
Innovative Therapy Development
San Diego, California, United States
Innovative therapies development, business development
Executive
MABPLEX USA, INC
CEO
MabPlex International Co., Ltd.
An integrated one stop CDMO for Biologics focusing on quality, speed and customer/product satisfaction with the successful track record of simultaneous global regulatory submissions from DNA to IND
Chief CMC Operations/VP BioManufacturing
BioAtla, Inc.
CAB Conditionally Active Biologics: ADC and Bispecific MAb CMC manufacturing/development/CGMP facility design/commissioning
COO/Managing Director
Biopharmaneer
San Diego, California
Bioprocessing, Single Use Bioreactor Technology, High cell density automated bioreactor perfusion system with integrated downstream purification, System Biomanufacturing Technology, Fast track scalable mammalian cell line development technologies, Biosimilars, Biobetters, Rx MAb: ADC, Bispecific; Slow release Insulin derivatives; Microbial Immunotherapy for autoimmune diseases, cancers and mucosal vaccines of viral/bacterial infections...
Product Development
Assembly Biosciences, Inc.
HBV anti-viral small molecules, global clinical/CMC/regulatory development, APAC business establishment Microbiome clinical/CMC/regulatory development
COO
Zhejiang BioParma
China
ONCOLOGY Rx MAb ADC CMC and clinical development
CSO
Phage Pharmaceuticals, Inc.
San Diego, California
USFDA/EMA approved CGMP manufacturing processes/facility for bacteriophages CMC/clinical/regulatory development of regenerative medicine therapeutics for cardiovascular diseases, diabetes related ulcers, tympanic membranes, anti-agings therapies; Processing and manufacturing of "difficult to produce" soluble proteins; Product development of PEGylated biosimilar/biobetter proteins/MAbs; 3 D structure based multimer molecules designs/ biologic binding optimizations.
VP, cGMP Manufacturing Operations
Phage Pharmaceuticals, Inc.
Design-built, Commissioned and Managed CGMP Manufacturing Facility operations for Therapeutic Proteins: cardiovascular regenerative medicine, wound healing and Biosimilars with Successful Regulatory Inspections from US State and Europe.
CEO/CTO
Symbigene
Microbial/Cellular mucosal expression/delivery technology for Therapeutic Peptides, Proteins, DNA and Vaccines. Autoimmune diseases: IBD; Vaccines: HIV, SARS, Influenza, Rotavirus
VP, Product Development and cGMP Manufacturing
CoRautus Genetics/Baxter
Design-built, Commissioned and Operated a cGMP Manufacturing Facility for Hemophilia Products, Viral Adeno Vectors and Blood Clotting Factor VIII with Successful Regulatory Inspections from US, State.
Education
Yale School of Medicine
Molecular Virology
Nagoya University
Bioreaction Engineering
The University of British Columbia
Molecular Virology
UCLA
Microbial engineering
Wei Chen PhD's Contact Information
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