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 Expert  108052

Expert in Biotechnology

Available for your Consulting and Expert Witness Needs

Pennsylvania (PA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert has practiced biotechnology since 1973. He has worked primarily in the development and troubleshooting of manufacturing processes and immunoassays. He has developed reagents for 21 analytes ranging from large proteins and antibodies to steroids, drugs, and labile peptide hormones. Expert uses statistically designed experiments to simultaneously analyze many variables. Co-optimization, a statistical approach to experimentation, yields robust solutions to biotechnology problems and hastens the identification of causative relationships and the most desirable settings in complex systems. He has used this technique extensively for troubleshooting and formulation optimization.

industrial biotechnology


applied biotechnology


statistical design of experiments

Expert has set up environmental monitoring, USP antimicrobial efficacy testing, and cGMP validation programs. He condensed the knowledge of first principles: antimicrobial action mechanisms, solubilities, observed incompatibilities, regulatory requirements, marketing considerations, and effective concentrations into a computerized expert system. This system predicts the best preservative systems to incorporate into aqueous reagents with a wide range of compositions and uses. Its predictions have shortened development cycle times by 6 to 12 months. Expert's expertise in antimicrobial preservation complements his knowledge of analyte stabilization in reagent formulation. He has designed stable, liquid reagents for insulin, anti-viral antibodies, other serum proteins, pituitary and thyroid hormones, and drugs.

antimicrobial preservation


chemical stabilization

Expert notes that biochemical systems have many interdependent variables; so, optimizing one variable at a time seldom results in optimum settings for all of the important variables. Cooptimization allows identification of the most important variables, recognition of interdependencies among them and simultaneous optimization with predicted outcomes for different combinations. It is essential for the efficient development, characterization and troubleshooting complex systems. Expert has used cooptimization for reagent development and troubleshooting, for process and test protocol optimization and for evaluation of temperature mapping of incubators, ovens and refrigerators.


Expert has worked in both cGMP and ISO-9000 environments, creating the necessary documentation for compliance. He has experience in research and development in clinical diagnostics and in quality assurance testing in pharmaceutical manufacturing. He has written and executed documents for the system life cycle concept of change control for instrument systems. He has integrated testing for "Year 2000" date compliance and for 21 CFR 11 Electronic Records and Signatures into system qualification documents.

Current Good Manufacturing Practice


qualification testing

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Philadelphia, Pennsylvania;  Allentown, Pennsylvania;  Reading, Pennsylvania;  Bethlehem, Pennsylvania;  Elizabeth, New Jersey;  Trenton, New Jersey;  Camden, New Jersey;  Wilmington, Delaware;  Baltimore, Maryland;  and Alexandria, Virginia.

Year   Degree   Subject   Institution   Honors
1981     Post-Doctoral Immunobiology   University of Wisconsin, Madison  
1980   Ph.D.   Biochemistry   Indiana University, Bloomington  
1973   M.S.   Biochemistry   Texas A&M University   Phi Sigma
1968   B.S.   Chemistry   Texas A&M University   Phi Kappa Phi

Work History:
Years   Employer   Department   Title   Responsibilities

1995 to


(Undisclosed Consulting Company)





Expert provides instrument qualification and chemist training to effect compliance with 21 CFR 11 and 211.

1988 to 1995


E.I. DuPont de Nemours & Co., Inc.




Senior Development Biochemist


He developed clinical diagnostic reagents for automated systems.

1981 to 1988


Micromedic Systems, Inc.




Senior Scientist


Expert supported all aspects of clinical diagnostic reagent manufacturing.

Career Accomplishments:

Expert is a member of the American Chemical Society.


Expert received DuPont's Innovator Award for creativity and innovation in 1991. At DuPont, Expert received Accomplishment Awards for antimicrobial preservative research and for troubleshooting instability of a liquid alkaline phosphatase conjugate for an ELISA assay.

Publications and Patents Summary

Expert has one publication and one patent. Most of his work is held as company confidential.

Selected Publications and Publishers  
 - Development Biology  
 - U.S. Patent and Trademark Office  

Government Experience:
Years   Agency   Role   Description
1969 to 1971   U.S. Army   Instructor and Platoon Leader   Expert was an instructor of land navigation at The Infantry School, Ft. Benning, GA and a platoon leader in the Republic of Korea.

Consulting Services:
Selected Consulting Examples:
  • Expert wrote and executed System Life Cycle documents for laboratory instruments and trained operators in compliance with 21 CFR 211.
  • He directed research for the development of clinical controls for prothrombin time and whole blood glucose.
  • Expert established and ran a USP-compliant laboratory for anti-microbial effectiveness testing.
  • He investigated and solved instability problems in insulin control solutions, a chelated metal reagent and creatine kinase calibrator.
  • Expert formulated a tableted alkaline phosphatase reagent.
Recent Client Requests:
  • Expert in industrial biochemistry for consulting on metal working coolant biocontrol.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert for consulting on microarray patent litigation.
  • Expert witness on immunology blood assays for consulting on ELISA spot assay analyzer.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Supplier and Vendor Location and Selection

Expert has experience locating vendors of OEM processes, biotechnology analytes, and human and non-human blood and tissue products.

Other Skills and Services

Expert has made dozens of significant technical contributions to clinical diagnostics. While most of these have been held as proprietary secrets, one of Expert's projects was granted a U.S. patent.

In addition, Expert has remedied non-specific binding (noise) problems in immunoblot (Western blot), RIA, IRMA, ELISA (enzyme-linked immunosorbent assay), and latex agglutination assays.


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