Bio-Development Consulting Services

CA

Experience in Facility Design, Commissioning and GMP Auditing

Wellcome Foundation Ltd., UK (Now GlaxoSmithKline) (1960-70) Inactivated poliovirus vaccine processing unit and final product formulation suite in the new production building GMP Audits of IV manufacturing plant and filling/lyophilization plant, Florence, Italy. National Institute of Health, Islamabad, Pakistan (1980-1984) Live poliovirus vaccine GMP formulation & filling facility. Design, retrofitting of building, validation of operations Attenuated measles virus vaccine complete GMP production. Design, commissioning and validation of new building Human diploid cell rabies virus vaccine GMP production facility: Design only. Kenyatta General Hospital, Nairobi, Kenya (1978) Design concept project for an IV manufacturing plant.

Connaught Laboratories, Canada (now Aventis Pasteur) (1984-1990) Multi-product GMP virus vaccine production building: Headed project team for the complete rebuilding of the 40, 000 sq. ft. facility, commissioning and validation of operations. Passed regulatory inspection on first visit. Two new GMP pilot plants for small-scale manufacture of clinical materials. Design, commissioning & validation.

Dalhousie University, Halifax Nova Scotia (1995) GMP pilot plant for the production of clinical-grade pharmaceuticals: Design

BioSante, Inc. Atlanta, GA (1997) New biopharmaceutical development laboratories: Design, commissioning.

Genencor Corporation, Rochester, NY (2001) Asssistance with planning of a new GMP Pilot Plant

Arius Research. Inc. Toronto, ON Establishment of QA system for GLP compliance and GMP auditing of contract manufacturing plant. Alberta Research Council, Edmonton, AB (2003) Assistance with the GMP upgrading of the main fermentation pilot plant

Regeneron Pharmaceuticals Inc., Tarrytown, NY (2004) Advice on the retrofitting of a pilot plant for GMP compliance.

Partial Client List Product Development, Project and Business Planning Stressgen Biotechnologies, Inc. British Columbia (Project Plans and Scientific Advisory Board member) Structured Biologicals, Inc. Toronto, ON (Now BioSante, Inc.) (Business Plan) Dalhousie University Schools of Pharmacy and Surgery, Halifax, Nova Scotia (2 Business Plans) Phenogene, Inc. Montreal, QE (Product Development Project Plan) QK Biologics, Toronto, ON (Business Plan for proposed contract manufacturer) ProteoCell Biotechnologies, Inc. Montreal, QE (Business Plan under discussion)

Client List - Public Training Courses in GMP, GLP, GCP, Validation and Drug Development

Organized by:

National University of Singapore (Bioprocess Technology Institute) Visiting Lecturer. Center for Professional Innovation and Education, Southeastern, PA. Professional Sciences Group, Toronto ON IBC USA, Inc. Westborough, MA

Partial Client List In-House Training Courses

DSM Inc., North Carolina Cephalon, Inc. Pennsylvania EISAI Pharmaceuticals, Inc. New Jersey Millenium Pharmaceuticals, Inc. Massachussetts MedImmune, Inc., Maryland Regeneron Pharmaceuticals, Inc. New York

Publications

Drug and Market Development Publications, Inc. Westborough, MA (www. drugandmarket. com) Guide to Good Laboratory Practice, October, 1999, Second edition published January 2004 Guide to Good Manufacturing Practice, January 2001, Second edition due August, 2004 Guide to Good Clinical Practice, May, 2001 Guide to Good Validation Practice, November 2001, second edition due November, 2004. Guide to Good Design Practices for GxP Compliance, April, 2003. Over 1, 000 copies of these various books have been sold to date. D&MD also published my in-depth Report on the Bioprocessing Industry in October 2000, with a second edition issued in January, 2003. The company also published a monthly BioProcess Newsletter, for which I was the contributing editor for the first eighteen months of its existence. I continued to write the Regulatory Affairs column for this publication, until it ceased issue in September, 2003. It has been replaced by BioProcess International magazine; I am on the editorial advisory board of the new journal and have contributed articles and notes.

541710, 541619

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