Protein Recombinant, Purification, Refolding and Characterization Expert

Technical Consultant #2083

Protein purification and refolding.
NMR and Crystallography protein purification using LC-MS to characterize proteins.
Over 40 years of industry experience in drug development
Current GMP
Specializing in developing new and very effective purification methods.
Specializing in assay development.
Purification of human insulin and Insulin analogs.
Human monocyte/neutrophil elastase inhibitor, developed the expression of MNEI in E coli.

Undisclosed Company, President and Founder, 2006 - 2013

Acquired facilities and people from a well-known pharmaceutical company.
Led company's biotechnologies to develop patented generic biologic products including human insulin, insulin analogs, human growth hormone. In addition to leading the scientific efforts, also responsible for the overall management.

Selected Accomplishments

Developed patentable processes for purification of human insulin and Insulin analogs.
Filed 9 patents covering this technology. The technology allows for the production of Insulins at approximately 10% the cost of current processes. This company is capable of producing patented generic biologics.
This company is capable of producing patented generic biologics.
Licensed IP for long acting Insulin to major European pharmaceutical company. License provides milestone payments and royalty payments that likely will be greater than $300 million.
Led a deal with Greenwood, IN; in which Greenwood built a 50,000 sq. ft. facility. This facility will be used for research, development and as a launch facility for generic biologics.
Supervised construction of 50,000 sq. ft. launch facility including a pilot facility with a 400L fermenter and plans for 2 -5000L. fermenters in the production area.
Worked with QA people to develop quality systems, including SOPs, instrument validations, Assay validations and process validations.

Indiana Protein Technologies, Greenwood, 2001 - 2006

Vice President and Chief Scientist

Manage a subsidiary responsible for protein research processes for IVAX Corporation. In addition to managing the business affairs of the entity, led the scientific team on several significant projects.

Selected Accomplishments

Human growth hormone-developed purification and analytical methods that were used to produce methionyl-human growth hormone under cGMP conditions for clinical trials, animal studies and stability studies. All of these studies have shown that the growth hormone produced with this process was equivalent to Protrophin.
MNEI (Human Monocyte/Neutrophil Elastase Inhibitor), developed the expression of MNEI in E coli along with a successful refolding process. By tagging the MNEI, produced highly purified, fully active MNEI in one chromatography step.
TP-38- Successfully transferred from the NIH the TP-38 project, which had been poorly developed with the final product uncharacterized and poorly understood. The revised process produced homogenous material that was fully characterized. Bridging studies allowed the clinical work on TP-38 to continue ensuring the success of the project.

Indiana Protein Technologies, Greenwood, IN, Founder, President, and Chief Scientist 1997 - 2001

Led the company from inception to its sale to IVAX Corporation growing it at a rate of 40% per year and recognition as one of the premier protein chemistry companies in the nation.
Successfully completed contract research and development projects on potential protein products for several pharmaceutical and biotechnology companies including Eli Lilly and Co., Millenium, Exoxemis, Biogen, Ontogeny, Breakthrough Technologies, Cook Biotech and others.
Received Senator Richard Lugar award for innovation.

Eli Lilly & Co., Indianapolis, IN, Senior Scientist, 1994 - 1996

Completed large scale purification of proteins for NMR and Crystallography using LC-MS to characterize proteins.
Completed several projects using tandem Mass Spectrometry to quantitate proteins in biological systems.
Set up GMP facility and developed GMP and QA procedures for clinical trial material.

Research Scientist, 1991 - 1994

Developed program to study the involvement of proteolytic enzymes in viral replication and infection.
Led effort to isolate and purify proteolytic enzymes from picornavirus and HIV. Purified and characterized Rhinovirus protease 3C from E coli.
Provided purified material for first crystallization and NMR structure determinations of 3C-protease.
Provided purified HIV protease for chemical and physical characterization.

Regulatory Manager and Head of Biochemical Scale Up Group, 1983 - 1990

Developed a GMP facility that could be used for multiple products simultaneously.
Trained staff on GMP procedures ensuring purifications met FDA requirements for clinical trial material.
Established QA protocols for stability testing of material produced.
Produced initial clinical trial lot of Human Growth Hormone and other proteins.
Developed high throughput methods including automation and informatics software.

Scientist, 1968 - 1983

Attempted to elucidate the involvement of proteolytic enzymes in the loss of Lerefellar neurons during the aging process and the effects on aging.
Investigated enzymatic control of emphysema and developed techniques to demonstrate clinically significant emphysema produced in laboratory animals without the use of enzymes.
Isolated and purified L-serine deaminase from E coli. Demonstrated a new enzyme pathway utilizing iron as a co-factor
Participated in isolation and purification of L-asparaginase from E coli. L-asparaginase currently used in treatment of acute lymphocytic leukemia.

Awards

Publications and Patents

Author and Co-Author of literature for peer reviewed journals, presentations and meetings,
Over 8 patents issued. Over a dozen patents filed and pending.