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William
R. Tolbert, President of WR Tolbert & Associates, LLC
has been an independent consultant in cGMP
manufacturing, specializing in cell-derived
biopharmaceuticals for over a decade. His corporate
experience includes 10 years in executive positions at
Invitron, Centocor and Advanced Tissue Sciences with
responsibility for
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Manufacturing Technology |
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Information Technology |
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Quality assurance |
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Quality control |
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Validation |
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Clinical production |
Earlier
he held the position of Monsanto Fellow associated with
the Monsanto/Harvard University research project on
tumor angiogenesis.
He is an
inventor on 26 patents and author of over 90
publications in the area of mammalian cell culture
systems and their use for the production of
biopharmaceuticals and biological devices. His
biotechnology patents formed the technical basis for the
contract manufacturing firm, Invitron Corporation, that
was subsequently purchased by Centocor (now a division
of Johnson & Johnson).
He is a founding member
of the Editorial Advisory Board for
BioPharm
International.
He has designed 40
facilities for the clinical and commercial manufacturing
of cell based products with 30 of them for cell and gene
therapy products. Examples of the conceptual design
approach and facility requirements are described under
Facility Design Services.
Many of these designs have been presented to the FDA in
Class C Meetings held with CBER / Division of
Manufacturing and Product Quality.
In addition to the biographical information
included on this website under the buttons above, you
may alwo view and/or download an MS WORD version of
Dr.
Tolbert's CV.
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