Keith Beatty

Picayune Memorial High School

Class of 1965

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First Name	Keith
Last Name	Beatty
Graduation Year	Class of 1965
Gender	Male
Current Location	San Diego, CA
About Me	Keith Beatty 5360 Toscana Way G316, San Diego, CA 92122 Phone: 858-457-8445, Email: kbeatty1@san.rr.com DEVELOPMENT SCIENTIST Protein chemist expert in process development and validation of GMP parenteral medicine manufacture. Expertise includes fermentation, bulk methods, chromatography, filtration, ultrafiltration, centrifugation, virus clearance, formulation, freeze drying, and heat stabilization of proteins. PROFESSIONAL EXPERIENCE Independent Investigator/Consultant, 1998 to present Developed a non toxic solvent for ear wax removal in collaboration with Visionary Medical Technologies Discovered a method for regenerating elastin in connective tissue Formulated a pharmaceutically acceptable cosmetic lotion for regenerating elastic tissue Wrote patent to cover applications of elastic tissue regeneration Amylin Pharmaceuticals(1997-1998) Amylin develops a peptide synthesis manufacture of a diabetes hormone Manufacturing Manager, Pharmaceutical Technology, San Diego, Ca, 1997-1998 Selected accomplishments: Managed contract manufacturers; Mallinckrodt Inc., St. Louis; UCB Bioproducts, S.A. Belgium; Cilag LTD., Switzerland; and Bachem, Los Angeles; in development & validation of solid` and Developed a ten-nanometer filtration for removal of pathogenic virus Wrote SOP’s, production records, validation protocols, critical change requests Managed the development of a process for recovery and resale of human albumin from fermenter media Coordinated quality assurance, regulatory affairs, marketing, validation, production, and engineering Provided manufacturing support for irregularities at the Berkeley site including aggregation of proteins, vacuum failures, cosmetic defects on stoppers, sterility failures, and liquid phase peptide synthesis Chaired the committee for investigation of alternate delivery systems Invented a buffer that prevents the aggregation of the peptide hormone Conceived of low volume needle free injection that is silent, painless, inexpensive, and convenient Chaired training meetings for the pharmaceutical technology department Bayer Biotechnology (1989-1996) Bayer Biotechnology manufactures recombinant antihemphilic factor protein by continuous flow fermentation of CHO cells. Bayer purifies protein parenteral pharmaceuticals from 5000 liter lots of human blood plasma. Staff Scientist, Manufacturing Technology, Berkeley, California, 1993-1996 Selected accomplishments: Invented a manufacture for alpha-1 PI that increased production yield from 0.31 to 0.52 g/plasma liter Systematically optimized every manufacturing variable in the new process. Specified equipment and wrote batch production records for purification, virus inactivation, formulation, and freeze drying. Supervised manufacture of ten 100 g toxicology lots using the new process. Reduced nonconformance for sterility, fermenter oxygen and temperature excursions by 90% in eight months Championed the development of a proteinase inhibitor as adjunct therapy for sepsis Cutter Laboratories division of Bayer Corporation The Cutter division purifies protein parenteral pharmaceuticals from 5,000 liter lots of human blood plasma. Senior Research Scientist, Manufacturing Technology, Berkeley, California, 1989-1992 Selected accomplishments: Provided expertise in manufacture of alpha-1-proteinase inhibitor from human plasma Increased production yield from 0.24 to 0.31 g/plasma liter Supervised development of alternate heat stabilizers Invented a new assay for alpha-1 PI Invented an LAL assay for pyrogens in alpha-1 PI Discovered a stable liquid formulation for alpha-1 PI Discovered methods to purify transgenic proteins from sheep’s milk Assessed solvent detergent and other virus inactivation methods Assessed pyrogen removal methods Devised and implemented precision adjustment of pH in manufacturing Armour Pharmaceutical Company Armour Pharmaceutical purifies protein parenteral pharmaceuticals from 10,000 liter lots of human blood plasma. Senior Development Scientist, Kankakee, Illinois; 1986-1989 Selected accomplishments: Served as a member of the Human Plasma Development group that scaled up the production of Monoclate®, the first antibody affinity chromatographically pure antihemophilic factor VIII;C. Prepared clinical lots and FDA conformance lots Measured the elution kinetics of product from the monoclonal antibody affinity resin Developed, wrote, and taught Q.C. Test procedures and manufacturing procedures Assayed the specific activity of the product, data was depositioned during patent litigation Invented and developed a pasteurization procedure for a new enzyme product Selected the resin support and coupling chemistry for a chromatographic production process Devised a mixing protocol for plasma types that reduces isoagglutinin titers in product Investigated antibacterial chromatography methods and endotoxin rework procedures Devised an assay for cyanide in 3 Molar thiocyanate process waste United States Army Chemical Corps Lieutenant, 1970-1971 EDUCATION University of Georgia, Athens, Georgia; Ph.D. Biochemistry, 1982 Title of Dissertation: “Alpha-1-Proteinase Inhibitor; A Study of the Kinetic Mechanism” University of Georgia, Athens, Georgia; M.S. Biochemistry, 1977 Title of Master’s Thesis: “The Inhibition of Plasmin by Alpha-1-Proteinase Inhibitor” Purdue University, West Lafayette, Indiana; B.S. Chemistry 1969 Purdue University, Postdoctoral Research Associate of Professor Michael Laskowski, 1984 1986 Set up an expert system to measure proteinase inhibitor association rate constants Georgia Institute of Technology, Research Associate of Professor Sheldon May,1983 1984 Synthesized an enzyme inhibitor and used it to probe the enzyme mechanism Grew Pseudomonas aeruginosa by continuous flow Chemap fermentation Isolated the enzyme protocatechuate 3,4-dioxygenase from the bacteria Pseudomonas aeruginosa University Louis Pasteur, Charge de Recherche, Strasbourg, France; 1982-1983 Investigated the reaction between porcine elastase and the alpha-2-macroglobulin proteinase inhibitor Established a purification laboratory and isolated gram quantities of seven human proteins Investigated the effect of the plasmin alpha-2-macroglobulin inhibitory complex on cell culture growth rates Titrated the human leucocyte elastase binding sites on structural elastin University of Georgia, Ph.D. Candidate of Professor James Travis, 1977-1982 Explained and described the kinetic mechanism of alpha-1-proteinase inhibitor Proved the first kinetic inhibition mechanism Measured the association rate constants of alpha-1 proteinase inhibitor Measured both forward and reverse dissociation rates of the alpha-1-proteinase inhibitory complex Invented an assay to measure percent oxidation of of alpha-1-proteinase inhibitor in blood University of Georgia, Master of Science candidate of Professor James Travis, 1973-1977 Investigated the inhibition of plasmin by alpha-1-proteinase inhibitor Devised a stable, 100% active preparation of plasmin to overcome the autolytic instability of plasmin Proved the existence of a stable complex between plasmin and alpha-1-proteinase inhibitor Discovered that alpha-1-proteinase inhibitor is a pseudo substrate or kinetic inhibitor PROFESSIONAL MEMBERSHIPS (PAST) American Chemical Society Parenteral Drug Association Sigma Xi SCIENCE AND TECHNOLOGY AWARDS 1996 BAYER QUALITY EXCELLENCE AWARD for reduction of Kogenate® cosmetic defects 1996 BAYER QUALITY EXCELLENCE AWARD for reduction of Kogenate® protein aggregates 1992 MILES SCIENCE AWARD, “Heat Shock Alpha-1 PI Process” 1991 MILES PHARMACEUTICAL DIVISION OUTSTANDING TECHNOLOGY AWARD, “Developing a heat shock process for increasing the yield of alpha-1 proteinase inhibitor” 1991 MILES TECHNOLOGY AWARD, “25% Prolastin® Yield Increase” PUBLICATIONS 1. K. Beatty, N. R. Matheson, and J. Travis. Evidence for the Inability of Oxidized Alpha-1-Proteinase Inhibitor to Protect Lung Elastin from Histolytic Breakdown. Hoppe-Seyler’s Z. Physiol. Chem. 365 (7), 731-736 (1984). 2. K. Beatty, J. Travis, and J. Bieth. The Effect of Alpha-2-Macroglobulin on the inhibition of Porcine Trypsin by Alpha-1-Proteinase Inhibitor, Biochimica et Biophysica Acta 704, 221-226 (1982). 3. K. Beatty, P. Robertie, I.E. Liener, and J. Travis. An Assay for Oxidation of Alpha-1-Proteinase Inhibitor in Plasma. Journal of Laboratory and Clinical Medicine 100 (2), 186-192 (1982). 4. J. Travis, K.Beatty, P.S. Wong, and N. R. Matheson. Oxidation of Alpha-1-Proteinase Inhibitor as a Major contributing Factor in the Development of Pulmonary Emphysema. Bull. Eur. Physiopath. Resp. 16 (suppl.), 341-351 (1980). 5. K. Beatty, J. Bieth, and J. Travis. Kinetics of Association of Serine Proteinases with Native and Oxidized Alpha-1-Proteinase Inhibitor and Alpha-1-Antichymotrypsin, J. Biol. Chem. 255, 3931-3934 (1980). 6. J. Travis, N.R. Matheson, D. Johnson, and K. Beatty. Human Alpha-1-Proteinase Inhibitor and Human Alpha-1-Antichymotrypsin: Properties and Mechanism Studies. In “Chemistry and Biology of Plasma Proteins,” ed. D. H. Bing (Pergammon Press, In c.) 1979, pp. 343-352. LIST OF SKILLS AND KEY WORDS TO AID YOUR COMPUTER SEARCH FORMULATION EXPERIENCE • Formulated development lots and conformance lots • Developed a formulation for Prolastin protein for injection • Developed a formulation for a cosmetic emulsion • Developed a formulation to dissolve cerumen • Developed a formulation for surface adsorbtion resistant peptides • Developed a formulation for aggregation resistant amylin peptide • Developed a formulation for endotoxin desorbtion • Investigated enzyme activity kinetic profiles • Investigated solvent detergent virus inactivation methods • Investigated chemical virus inactivation methods • Freeze drying theory, practice, and development • Developed a freeze dry cycle • Investigated formulation related freeze drying issues • Operated research & development freeze dryers • Studied ambient temperature lyophilization excipients • Investigated vacuum testing issues • Investigated freeze dried cake cosmetic issues • Protein heat stability theory practice and development • Developed a heat stable formulation for heat shock purification • Participated in Factor VIIIc dry heat virus inactivation studies • Identified protein Pasteurization formulations for virus inactivation • Emulsion theory, practice, and development • Developed a stable emulsion formulation • Developed a manufacturing method to break a stable emulsion FERMENTATION AND CELL CULTURE EXPERIENCE • 50 liter batch bacteria fermentation • Cultured rat aorta smooth muscle cells • Investigated manufacturing deviations of CHO cell recombinant Factor VIIIc fermentation PROTEIN CHEMISTRY EXPERIENCE Proteins isolated • Albumin • Alkaline phosphatase • Alpha-1-proteinase inhibitor • Alpha-2-macroglobulin • Antihemophilic factor VIII:c • Antihemophilic factor IX • Caeruloplasmin • Elastase • Elastin • Orosomucoid • Plasminogen • Plasmin • Protocatechuatee,3,4-dioxygenase • Transferrin Protein Characterization • Amino acid analysis • amino terminal sequence • c terminal analysis • molecular weight studies • analytical ultracentrifugation - sedimentation equilibrium - sedimentation velocity - extinction coefficient • Bradford protein concentration • Electrophoresis - alkaline, acid, and SDS polyacrylamide • Turbidity Enzyme kinetics and thermodynamics • Active site titration of proteinases • Km, Ki, kcat, determinations • pH, and temperature effects • Proteinase versus proteinase inhibitor studies - kon - koff - Kequilibrium PROTEIN ISOLATION EXPERIENCE Laboratory Scale • High pressure liquid chromatography - TSK - Mono Q - C-18 • Radial flow chromatography • Liquid column chromatography - Pharmacie FPLC - Biocad - ion exchange - gel filtration, size exclusion - coupling of affinity ligands - affinity and coupling of affinity ligands - monoclonal antibody affinity and coupling of antibodies - hydrophobic interaction (HIC) - protein A - T-gel - zinc chelate Sepharose - Trasylol Sepharose - Cibachron Blue Sepharose amino hexyl Sepharose polymyxin B Sepharose lima bean inhibitor Sepharose benzamidine Sepharose Industrial Scale Protein Isolation Experience • Manufacturing Process Development & Optimisation • Very Large Scale Column Chromatography - 5L, 15L, 50L, 100L monoclonal antibody affinity - 20L Sephadex G25 stack column - 150 L DEAE Sepharose column • Bulk precipitation methods - Cohn fractionation - Polyethylene Glycol (PEG) - Ammonium sulfate - 60 degree centigrade heat • Filter presses 18, 24, 36 inch • Sharples continuous centrifugation • Ultrafiltration and diafiltration - Amicon pellicon - Amicon minitan - Filtron - Romicon hollow fiber • non denaturing Industrial pumps • Sterility methods - aseptic processing - autoclaving - sterile filtration - 10 nanometer virus filtration at 100 gram scale - sterile bulk preparation - sterile fill - sterile water for injection - pasteurization of blood products - solvent detergent virus removal • GMP - Production of clinical lots, toxicology lots, and conformance lots - Validation - Writing of manufacturing and QC test procedures - Writing SOP’s, and manufacturing batch production records - Design of GMP production facility TECHNICAL WRITING • Landmark Publication in Journal of Biological Chemistry • Batch Production Record • Validation Protocols • QC Analytical Method • Minutes of Technical Meetings • Technical Investigation Reports • Patent Application • Patent Disclosures MANAGEMENT EXPERIENCE • Influence management and direct supervision of four contract manufacturers to Amylin Pharmaceutical Company • Supervised the laboratory investigation of novel purification methods for alpha-1PI • Supervised pilot scale development and toxicology lot preparations of alpha-1PI, and albumin • Coordinated site wide development of albumin recovery from recombinant tissue culture fluids for Bayer Biotechnology • Coordinated site wide corrective action to reduce the frequency of fermentation nonconformance for Bayer Biotechnology • Participated in routine application of the Demming Management Method to protein parenteral pharmaceutical manufacturing • Chair & Schedule meetings, Liaison • Executive Officer, Headquarters Company, 4th Combat Support Training Brigade, US Army ANALYTICAL LABORATORY EXPERIENCE Chromatography • HPLC • GC • TLC • FPLC • Biocad Spectroscopy • Infrared • Nuclear magnetic resonance • GC-mass spectroscopy • UV/visible absorption and fluorescence • stopped flow • anaerobic spectroscopy Detection Methods • pH electrodes • Oxygen electrodes &...(read more)