William R. Tolbert
Consultant in Pharmaceutical/Biopharmaceutical Manufacturing, cGMPs, Facility Design, Cell/Gene Therapy, Biotechnology
- Role
- President at Wr Tolbert & Associates, Llc
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About William R. Tolbert
Bill Tolbert is an independent consultant in cGMP manufacturing, quality and facility…
Experience
President
May 1995 — Present
Bill Tolbert\'s expertise is in product/process development and cGMP manufacturing of biopharmaceutical cell-based products: including rDNA proteins, monoclonal antibodies and cell/gene therapy modalities. He is an inventor on 26 patents and author of over 90 publications. His firm consults with academic, biotech and large pharma organizations on cGMP manufacturing issues, particularly those related to cell-based products. In addition, he assists clients in the development and implementation of process and quality systems for all phases of clinical manufacturing. He has designed 40 facilities for both clinical and commercial cGMP manufacturing operations, including 30 for cell and gene therapy. Many of these plans have been presented for review with FDA/CBER, Division of Manufacturing and Product Quality.
Education
University of Richmond
BS, Physics
1960 — 1964
University of Wisconsin-Madison
Ph.D., BioPhysics
1964 — 1971
Skills
- CRO
- Commercialization
- Toxicology
- Oncology
- Monoclonal Antibodies
- Pharmaceutical Industry
- Sop
- Immunology
- Fda
- Genetics
- Cell
- Clinical Trials
- Hplc
- Chromatography
- Cell Biology
- Biotechnology
- Regulatory Affairs
- Lifesciences
- Gmp
- Clinical Development
- Regulatory Submissions
- Validation
- Vaccines
- Laboratory
- Drug Development
- Cancer
- Biopharmaceuticals
- Biochemistry
- Manufacturing
- Infectious Diseases
- Microbiology
- Hardware Diagnostics
- Product Development
- Technology Transfer
- Genomics
- Pharmacology
- Cell Culture
- Drug Discovery
- Medical Devices
- Clinical Research
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