Microbiologist Consultant for Microbial Cell Culture and Fermentation, Process and Equipment Validation Expert

Technical Consultant #1677


Expertise

  • Over thirty years of research, development, QA/QC, technical service, validation, manufacturing and engineering management experience in the food, pharmaceutical and biotech industries.
  • Design, construction, scale-up, start-up, validation and operation of biotechnology and pharmaceutical manufacturing equipment and processes.
  • Validation activities for pharmaceutical processes, for example, in an aseptic fill and finish facility for ophthalmic and parenteral solutions.
  • Microbial physiology, biochemistry and genetic mechanisms controlling the metabolism of microbial products.
  • Enzymology, rDNA technology and related regulatory procedures.
  • Installation and cooperation of microbial cell culture facility and large fermentation process.
  • Project evaluation, selection and control of activities in U.S. and overseas operations.
  • Microbial fermentation process development, scale-up, manufacture and recovery of industrial enzymes produced by microbial (bacterial) fermentation.
  • Microbial fermentation of enzymes used in the production of high fructose corn sweeteners.

Expert Witness Experience

  • Expert testimony related to suspected theft of proprietary technology in biotechnology process and microbial strains.

Experience

Independent Consultant, 2003 - Present

Projects for Confidential Clients

  • Developed procedures for the purification of a pharmaceutical protein product produced by fermentation using rDNA technology.
  • Unit operations included several chromatographic steps and lyophilization of the purified product.
  • Developed analytical methodology to demonstrate a cleaning process and met efficacy requirements (ELISA analysis to pictogram level).
  • Working with the VP of Sales, and Director, Pharmaceutical Engineering, developed a business plan and strategy for entering the biotechnology and pharmaceutical manufacturing sector.

Gambro, Opelika, AL, 2008

  • Start-up of a grass roots manufacturing facility for the manufacture of blood dialysis filters.
  • Plant construction introducing a new generation of Gambro's Polyflux® Revaclear MAX blood dialysis filtration cartridges; designed to function as a fully and vertically integrated facility in which all filter parts are manufactured at the Opelika facility.
  • Trouble shooting all unit operations including filter housing molding operations, fiber spinning operation, sterilization and packaging, and ensuring all operation documents reflected the requirements necessary for FDA acceptance.

Akorn, Inc., Decatur, IL, 2002 - 2003

  • Advisor for validation activities in an aseptic fill and finish pharmaceutical manufacturing facility (ophthalmic and parenteral solutions).
  • Reinstitution of cGMP practices in areas of process, equipment and facilities.
  • Unit operations and protocol development included CIP System, aseptic filtering integrity testing, head space analysis and terminal sterilization with steam (i.e. numerous autoclaves).

Amgen, Juncos, Puerto Rico, 2002

  • Production, purification and finishing facility for two injectable drug products (API's: Epogen and Neupogen, produced via rDNA technology).
  • Ensure all activities associated with the design, construction and star-up of facility in compliance with Federal and European regulations for the manufacture of a parenteral drug product.

Eli Lilly and Company, Carolina, Puerto Rico, 2002

  • Production, purification and finishing facility for an injectable drug product (API: Humalog) for human long-acting insulin produced via a rDNA.
  • Humelog API purified by very extensive procedures of isolation, solubilization, chemical cross-linking and column chromatography and tangential-flow filtration and concentration.
  • Ensured that all activities associated with the design and construction of this grass roots facility where in compliance with Federal and European regulations for drug manufacturing.

Astra Zeneca/IPR Pharmaceuticals, Canovanis, Puerto Rico, 2000 - 2001

  • Multi-product facility for blending and packaging of oral drug products (API's: Casadex, chemical impotence drug; Zomig, chemically produced for treatment of migraine headaches; Retrol, an anti-cholesterol drug).
  • Project Manager responsible for installation, pre-commissioning and start-up of the various systems with this grass roots biotechnology facility.
  • Facility constructed for the manufacture and packaging of a pharmaceutical tablet product.
  • Systems included formulation, blending, fluid bed drying, tablet pressing and coating, clean utilities, CIP and related operations.

Enyyme Technology Corporation, Ashland, OH, 1984 - 1996

  • As Vice President of: Research, Development, Quality and Assurance, led Team responsible for the scale-up and recovery of numerous industrial enzymes produced by microbial fermentation processes.
  • Fermentation products included glucoamyase (amyloglucosidase), alpha-amylase and glucose (xylose) isomerase, all three of which are utilized in the production of sweetener (HFCS) from corn starch.
  • Fermentation processes ranged from pilot plant (approximately 10 gallons) to full-scale industrial fermenters (over 30, 000 gallons).
  • Recovery unit operations consisted of filtration (deep bed rotary drum, cross-flow and diafiltration) and evaporative concentration.

Honors & Publications

Academic and Professional Affiliations

  • American Chemical Society
  • American Society for Microbiology
  • International Society for Pharmaceutical Engineering
  • Enzyme Technical Association - member, Board of Directors
  • Ohio State University Technical Advisory Committee - Agricultural Institute, Ohio State University

Education

  • Ph.D. Microbiology, Iowa State University, Ames, IA
  • M.S. Microbiology, Iowa State University, Ames, IA
  • B.S. Biology, Animal Science, Iowa State University, Ames, IA
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