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Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge in finding suitable enzyme assays (Triglyceride assay kit) and to stabilize enzymes for use in clinical chemistry assays and in comprehensive three level serum controls with 25 constituents. This knowledge was also useful in stabilizing hormones in serum controls.
He spent over 35 years in diagnostics making in vitro tests for hospital laboratories. Using his Biochemistry and enzyme background he was able to work in clinical chemistry, coagulation, immunology, and infectious diseases to make 150,000,000 tests for the hospital market, particularly in coagulation. The expertise he acquired and used to make product spans research, development, scale-up in manufacturing, process development and product launch. He solved problems in Manufacturing Technologies, and product support, particularly in coagulation, infectious diseases and diabetes liquid controls.
Changes in manufacturing yields or problems with existing product lines were often traced to inadequate instructions, changes in raw material quality, vial and stopper issues, precipitates in serum controls, light sensitivity, and bacterial contamination from the raw material or handling . Many of these problems were fixed with simple solutions following the acquired guide of "good lots bad lot what is the difference in performance and stability".
This required a thorough understanding of the raw materials, and process before making recommendation to all departments.
He has written protocols, research and development reports, manufacturing directions, filed 510K submissions, and obtained the CE mark for European sale of product, while working with patent attorney's, marketing, clinical investigators, QC, and planners to get the job done.
He has made product over a range of conditions including lyophilization (freeze drying), dry blending, tableting, and as a liquid presentation. The liquid thromboplastin reagent has two patents, and required extensive acquired knowledge in methods to kill bacteria (patent summarize 40 combinations before selecting four for addition), and in additives to improve stability. Bacterial contamination is so prevalent in the non-sterile manufacturing environment that raw materials or finished goods often required irradiation in a gamma pile. The correct dose to kill up to a million bacteria, in a liquid mL or a gram of solid, and without affecting either the performance or the stability was determined.
Whereas the first 37 years were spent mainly in detection of heart disease the last five years were devoted to cancer detection. The entire process for primary H&E staining of patient tissue was investigated including preservative, paraffin type, conditions for processing, additives, slide type, and storage conditions. A new instrument for Special Stains was in development, which required a massive material compatibility study involving a thousand samples over two temperatures and weeks of time while generating 15,000 data points. The report was written and recommendations were made, particularly in the choice of rubber O-rings and plastic parts. The differences in steel parts and finishes was also investigated, particularly when the parts were made in other countries where quality might be suspect.
It is unusual to find a PhD Biochemist with knowledge that has spanned five different areas of the hospital laboratory and all aspects involved in either making a product from conception to fixing a previously released product using knowledge gained in R&D and Manufacturing.

Expert has worked in Biochemistry for over 35 years, particularly in the Diagnostics field performing the research, development, scale-up and manufacturing processes required to produce 150,000,000 tests for the Hospital Laboratory. His PhD is in Biochemistry - Enzymology and Enzyme kinetics. A number of the serum control constituents were enzymes that required working with those enzymes from different species to obtain a stable product. The clinical chemistry reagents required multiple enzyme reactions to produce a product that could be measured spectrophotometricallly. He has worked with platelets, collagen, human and bovine serum, enzymes, proteins either to produce a product or to stabilize a reagent.