Expert in Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert ID: 730118 Washington, USA
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), Expert 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.
|Year: 1981||Degree: PhD||Subject: Biochemistry-Enzymology, enzyme kinetics and mechanism||Institution: Seton Hall University|
|Year: 1970||Degree: MS Biochemistry - Minor in Biophysics||Subject: Protein anlysis of Hemocyanin - Hemocyanins carry oxygen in the hemolymph of most molluscs, and some arthropods, including the horseshoe crab, Limulus polyphemus.||Institution: Fordham University|
|Year: 1968||Degree: BS||Subject: Chemistry||Institution: St. Francis College|
|Years: 2007 to 2012||Employer: Ventana Medical systems, Ins||Title: Senior Scientist||Department: Systems Integration/Assay Integration|
Responsible for pre-analytical studies/recommendations, and trouble shooting on Symphony H&E primary stainer used for Cancer detection
Raw material evaluations for the next generation H&E stainer
Material compatibility studies for new Benchmark Special Stains instrument used for detection of bacteria and other disease states.
|Years: 2006 to 2007||Employer: Hemagen and Beckman Coulter Companies||Title: Consultant||Department: Clinical Chemistry|
Responsibilities:Responsible for lyophilizer performance issues - wrote report, recommendations
Isolated and identified precipitate in animal sera base and suggested fix
Responsible for and validated replacement enzymes in liquid and Expert blend clinical chemistry reagent kits
|Years: 2004 to 2006||Employer: Abbott Laboratories, Inc.||Title: Principle Tech Support Scientist||Department: Cancer and Congenital Diseases|
Responsibilities:Responsible for determining the cause of shedding/precipitate formations in all liquid human sera bases, particular the Rubella controls - found cause, and fix
Investigated issues with all sera bases both animal and human
|Years: 2002 to 2004||Employer: Fisher Diagnostics||Title: Applications Scientist||Department: Clinical Chemistry/Coagulation|
Responsibilities:Documented CE Mark for coagulation product line
Researched/Developed irradiation dose for snake venom used in blood collection tubes
Reduced failure rate from 20% to 0% for manufactured glucose aqueous controls
|Years: 1990 to 2002||Employer: AKZO Nonbel||Title: Principle Process Engineer/Principle Scientist||Department: Organon Teknika - sold to bioMerieux|
Responsibilities:Researched/Developed/Scaled-up/Transferred to Mnaufacturing Liquid Coagulation reagent - Simplastin L - 2 patents - 110 million tests over 12 years
Validated new raw materials for Simplastin L
Solved light sensitivity issue with alternative colored vial
Researched/Developed/Scaled-Up/Transferred to Manufacturing 2nd Liquid Coagulation reagent - Simplastin LS
Transferred next generation Coagulation reagent to manufacturing - Simplastin HTF
|Years: 1987 to 1990||Employer: Electro-Nucleonics, Inc.(Soldto Scaparille)||Title: Manager R&D||Department: Clinical Chemistry|
Responsibilities:Obtained 510K submission for new automated pipettor for clinical chemistry analyzer
Completed 15 OEM reagent applications and 5 new reagent applications for new random access clinical chemistry analyzer
Solved plastics contamination problem for calcium reagent
Served as Radiation safety Officer
|Years: 1983 to 1987||Employer: Ortho Diagnostics and Baker Instruments||Title: Senior Scientist/Group Leader||Department: Senior Scientist|
Responsibilities:Responsible for OEM acquisition of hormone serum calibrators for new assays
Technical audits of selected vendors were required
Developed hormone assays for protype laser/gold particle immoassay instrument through several breadboards
Developed clinical chemistry serum controls for OEM sales to Kodak using Kodak formulations
Completed Rearch/Development/Scale-up for new triglyceride reagent
|Years: 1970 to 1983||Employer: Warner Lambert (now Pfizer)||Title: Group Leader||Department: General Diagnostics|
Responsibilities:Responsible for the Research/Development/Scale-Up/Transfer to Manufacturing of coagulation reagents and serum controls - lyophilized, liquid, and Expert-blend
5 Patents and 4 products sold 40 million tests over 20 years of sales
Liquid Comprehensive (30 analytes at 3 levels) Clinical Chemistry Serum Control
Liquid Comprehensive (15 analytes at 3 levels) Drug Control (Patent application)
|Associations / Societies|
|American Chemical Society|
|Publications and Patents Summary|
150.000.000 tests researched, developed, and manufactured
|Found vendor (Srerigenics) to irradiate raw materials and products used in two companies. (Fisher Diagnostics and AKZO NOBEL). Worked with vendor each time to derive correct dose of gamma irradiation to eliminate bacteria while maintaining the integrity (performance and stability) of the raw materials and finished product.
Found company in Texas to make Human serum controls for hormone assays (for Ortho Diagnostics).
Found vendors to analyze precipitates in serum controls (in Warner Lambert- General Diagnostics AKZO NOBEL - Organon Teknika, Beckman Couler, and Abbott Labs)
|Made serum controls at Fisher Diagnostics (OEM vendor) for Kodak Labs instruments
Serum controls are used to monitor the assay quality results of the patient tests (i.e. cholesterol) produced on many hospital instruments and laboratories. They are a very necessary, and frequently neglected product. Expert has over twenty years experience successfully preparing serum controls for a variety of tests and hospital instruments.
Precipitates seem to occur frequently in several company serum/animal products and the problem has been solved each time - a similar process was used and is still being used in the diagnostic industry
Light sensitivity can be a common problem and it has been solved by understanding and using the physical properties of light.
Bacterial contamination has been a common problem across several companies. The right process, handling conditions, and anti-microbial addition can either greatly reduce or eliminate the bacterial contamination. At times irradiation has been use to eliminate bacteria in a variety of products over several companies.
Poorly written instructions has been a major source of errors in manufacturing processes. Once the process and raw materials used have been evaluated a simple correction has often elevated the instructions from "tribal knowledge" to a highly reliable process. A simple solution has often been observed for many conditions.
Vials and stopper closures have been found to affect performance and stability. The difference in molded and tubular glass was found to have a considerable affect, while the rubber ingredients in stoppers was also found to affect both liquid and lyophilized product..
The experience with NAD Kinase has led to suggesting inhibitors (invention record) for metabolism in cancer cells since NAD Kinase is the only enzyme that makes NADP, which is then used by critical metabolic enzymes down stream.
Fields of Expertise
assay, blood coagulation, blood testing, diagnostic reagent, enzyme, enzyme activity assay, enzyme inactivation, enzyme inhibitor, enzyme kinetics, enzyme stability, enzyme technique, in vitro diagnostics, new product development, process development, protocol, testing, coagulation, research and development, kinase, biochemistry, clinical chemistry, clinical diagnostics, enzymology, manufacturing research and development, applied biochemistry, cancer diagnosis, collagen research, assay development, clinical measurement, powdered reagent, reagent manufacturing, CE Marking, blood chemistry, immunodiagnostics, medical microbiology, blood assay diagnostic instrumentation, clinical enzymology, biochemical process development, biochemical research, manufacturing process development, diagnostic instrument, materials testing, coagulase, research, blood serum, serum protein, immunoassay, hematology