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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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