SUMMARY
An experienced Analytical Biochemist knowledgeable in all facets of Quality Control, Quality Assurance, ISO
9000, Quality Systems, Quality Auditing, Assay Development , and Regulatory Affairs . A leader for resolving problems and troubleshooting complex situations related to Manufacturing, Quality Assurance , and Quality
Control of Biopharmaceuticals . A seasoned scientist capable of finding practical solutions to Quality-related problems . An experienced manager capable of managing groups of up to 65 people and directing complex projects.
SKILLS AND ABILITIES IN:

Quality Assurance (QA), Quality Control (QC), and Analytical Biochemistry of biopharmaceuticals , including proteins, cellular entities, vectors, and “ biological devices .”

Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations as they apply to drugs and biologics.

Validations and development of assays, processes, instruments, and equipment; familiar with environmental and software validations.

U.S. and European regulations (including ICH) related to the QA and QC of biopharmaceutics and devices.
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Auditing of sub-contractors, suppliers, internal departments, sister divisions, and contract testing laboratories.

Aseptic Processing for the production of parenteral drugs and biologics.

Statistics for the testing laboratory and process validations.

Training in Quality-related matters and laboratory statistics .

American Society for Quality Certified Quality Engineer, Quality Auditor, and Quality Technician.

Regulatory Affairs Professionals Society Certified, RAC (Regulatory Affairs Certified).
AREAS OF SPECIAL ACHIEVEMENT:

Developed analytical methods for a QC department in the areas of blood derivatives, enzyme assays, control chemistries, and tissue culture-based procedures.
 
Using the techniques of analytical chemistry , investigated and solved a problem that was becoming a regulatory issue in Japan . It was related to a cosmetic defect in a protein solution.

Team leader for a group of analysts that defined and solved a major production-related particle problem in a recombinant parenteral protein solution..

Served as the QA/QC team member in a project team that licensed one of the first recombinant DNA products .
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Lectured and published in the areas of Quality Control and Assurance of Biologics and Devices.
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Member of the Editorial Advisory Boards of BioPharm, BioQuality and the Journal of GXP Compliance.

Instructor, University of California, Santa Cruz, Extension Service.

EXPERIENCE
GXP BIOTECHNOLOGY LLC, Sunnyvale, California
PRINCIPAL CONSULTANT
3/04 to Present
SERVICES;
Provide consulting services in the areas of GMP, GLP, Assay and Product Development to manufacturers and testing laboratories. Provide training in these areas as well as General Quality Management including Six Sigma and Process
Control.
7/01 to 3/04 TITAN PHARMACEUTICAL CORP., South San Francisco, California
DIRECTOR OF QUALITY CONTROL AND ASSAY DEVELOPMENT
DUTIES: a. Responsible for corporate Quality Control activities related to the contract manufacturing of products. b. Responsible for selecting and auditing of contract testing and manufacturing laboratories. c. Review, approve, and monitor assay development, validation and execution at contract testing laboratories. d. Responsible for GLP, GMP, and other regulatory interactions with contract manufacturing and testing organizations. e. Responsible for reviewing manufacturing and testing practices of contractors and certifying the releasability of manufactured products from contractors and suppliers.
KUWAHARA CONSULTING, Sunnyvale, California.
PRINCIPAL CONSULTANT
BIORELIANCE CORP., Rockville, MD and Sunnyvale, California
DIRECTOR OF ASSAY VALIDATION, BioSafety Division
8/00 to 7/01
SERVICES: a.
General QA/QC issues related to the development or manufacture of biotechnological products. b.
Auditing of internal departments, contractors and suppliers. c.
Validations of assays, manufacturing processes, cleaning processes, virus removal methods. d.
Stability and sterility studies. e.
Training on GMP, GLP, and laboratory statistics. f.
Technical writing, including the preparation of submissions and organization of documentation systems.
7/99 to 8/00
DUTIES: a.
Responsible for the development and management of the corporate assay validation program, with emphasis on
Biological Assays, including PCR testing on viruses. b.
Responsible for providing statistical support to clients and internal scientists. c.
Represented the company by making quality-related presentations to various groups and organizations. d.
Provide technical support to Sales and Marketing personnel and, upon request, to clients.

SYSTEMIX, Inc., Palo Alto, California
DIRECTOR OF QUALITY CONTROL, Quality Control Department
10/96 to 7/99
DUTIES: a. Responsible for management of the operations of the Quality Control Department that consisted of four laboratories under the direction of two managers and a supervising scientist. In addition to traditional microbiology and chemical analyses, these laboratories perform cellular phenotype analysis by fluorescent activated cell-sorting, PCR-based assays for viruses and culture assays for replication competent viruses and mycoplasma contamination, and tissue culture based assays for cytotoxicity and lymphocyte differentiation. b. Responsible for developing and maintaining the quality control program for a stem cell based biologic product and a gene therapy based product. c. Responsible for developing and maintaining the quality control program for small and large molecule reagents that are used to support the manipulation of stem cells and a gene therapy product. d. Provide quality control support for regulatory submissions and clinical trials. e. Provide quality control support for operations in a division located in France.
ALPHA THERAPEUTIC CORPORATION, Los Angeles, California. 10/95 to 9/96
PRINCIPAL SCIENTIST, Methods Development and Validation Department
DUTIES: a. Supervise or personally conduct assay development and validation studies related to blood proteins.. b. Develop and write policies related to assay validations, assay transfers and raw material management.
PYRAMID LABORATORIES, Costa Mesa, California.
TECHNICAL DIRECTOR
3/95 - 10/95
DUTIES: a. Supervise and conduct assay development and validation studies. b. Supervise and conduct preparation and certification of standards and control preparations. c. Design and conduct stability studies for client samples. d. Provide advice and counseling on quality control and quality assurance matters to clients. e. Serve as a contact person to discuss client's needs and Pyramid's laboratory capabilities in the area of biochemical analysis..
BAXTER HEALTHCARE CORPORATION 1982 - 1995
Immunotherapy Division , Irvine, California
Manager of Quality Systems Operations / Manager of Validations: RA/QA Dept.
(1992 - 1995)
Responsible for the management of Quality Systems Operations in regard to a cell selection device; performed internal and external audits. Reviewed, planned, and approved assay, process (including virus reduction), and software validation studies. Responsible for QA and QC in the division. Assisted in the preparation of device-related regulatory submissions for the U.S. and Europe. Also assisted with European submissions for the licensing of monoclonal antibody derived and recombinant DNA derived proteins.
Hyland Division , Duarte, California 1990 - 1992
Manager of Test Technology , Quality Assurance Department. (1990 - 1992)
Managed an analytical development and special testing laboratory. QC input for process and product specifications for plasma protein products. QC/QA interface with international operations and regulatory affairs.
Manager of Laboratories , Quality Assurance Department (1987-1990)
Managed the administrative and scientific activities of the QA testing laboratories, to include: Chemistry,
Immunology, Production Support, Coagulation, Biology, Test Technology and the Animal Test Laboratories, with a staff of 65.

Manager of Test Technology , Quality Assurance Department (1982-1987)
Managed the investigation of biochemical composition and properties of blood derivatives. Performed and supervised assay development studies.
MICHIGAN DEPARTMENT OF PUBLIC HEALTH , Lansing, Michigan 1973-1982
Section Chief / Public Health Clinical Laboratory Scientist X (1978-1982)
Biochemistry & Bioassay Section, Biologic Products Program, Bureau of Disease Control and Lab Services
Responsible for the administrative and scientific direction of the Chemical Testing, Bioassay, and Research Units.
Investigated and resolved unusual events related to blood proteins, bacterial, and viral vaccines. Supervised testing of Diphtheria, Pertussis, Typhoid, Tetanus, Small Pox, Anthrax and Rabies Vaccines and Blood Derivatives.
Section Chief/Biochemist 13, Product Analysis Section
Division of Biologic Products, Bureau of Disease Control and Laboratory Services
Responsible for the scientific and administrative supervision of chemical testing and research units. Performed research on the importance of carbohydrate groups in platelet aggregation.
Unit Chief/Chemist 13, Research Unit, Product Analysis Section
Responsible for the development of a clinically useful preparation of bovine antihemophilic factor (Factor VIII).
Studies on the modification of bovine factor VIII to destroy its ability to aggregate human platelets.
EDUCATION
University of Wisconsin , Madison, Wisconsin, Doctor of Philosophy in Biochemistry
University of Wisconsin , Madison, Wisconsin, Master of Science in Biochemistry
Cornell University , Ithaca, New York, Bachelor of Science in Biochemistry
·. American Society for Quality
·. American Chemical Society
·. American Society for Microbiology
American Association of Blood Banks
PROFESSIONAL SOCIETIES
New York Academy of Sciences
Regulatory Affairs Professionals Society
·. Parenteral Drug Association
CERTIFICATIONS
REGISTRAR ACCREDITATION BOARD (ISO) - Quality Systems Lead Auditor. 1994 – 1997.
AMERICAN SOCIETY FOR QUALITY - Quality Auditor (CQA). Certification No. 14026. Current.
AMERICAN SOCIETY FOR QUALITY - Quality Technician (CQT). Certification No. 11561. Current.
AMERICAN SOCIETY FOR QUALITY - Quality Engineer (CQE), Certification No. 35547. Current.
STATE OF CALIFORNIA DEPARTMENT OF CONSUMER AFFAIRS BOARD OF PHARMACY - Exemptee;
Wholsaler of Dangerous Drugs and Devices; License No. EXC 13985. Currently in suspension.
REGULATORY AFFAIRS PROFESSIONALS SOCIETY – Regulatory Affairs Certified (RAC, 1998)
RECENT PUBLICATIONS

“Industrial Quality for the Start-Up BioTech Company.” Chapter 17, Steven S. Kuwahara in Pharmaceutical
Quality. R. Prince (ed.), PDA, Bethesda, MD & DHI Publishing LLC, River Grove, IL, 2004, pp. 603 – 635.
 “Regulatory Status of Laboratories Used in Clinical Trials.” Steven S. Kuwahara, J. GXP Compliance 7 (4) 41 –
44 (2003).

STEVEN S. KUWAHARA, Ph.D.
GXP BioTechnology, LLC
PMB 506, 1669-2 Hollenbeck Avenue
Sunnyvale, CA 94087-5042
ADDENDUM TO RESUME
ADDITIONAL PUBLICATIONS AND PRESENTATIONS:
BOOKS:
 “ Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to U.S.,
European, and ISO Requirements.” S.S. Kuwahara, ASQ Quality Press, Milwaukee, WI
(1998) 236 pages. (Second edition of the book listed below.)

“Practical Guide to GMPs for Device and Diagnostic Manufacturers: 21 CFR 820, effective
June, 1997, EN 46001, ISO 9001.” S. S. Kuwahara, Interpharm Press, Buffalo Grove, IL
(1997) 192 pages.
PUBLICATIONS:
 “In Vitro – In Vivo Correlations Heading for the Big Time? Dissolution Testing Not Just for Oral Dosage
Forms.” Meeting Report. Steven S. Kuwahara, BioQuality 8 (7) 4 (2003).
 “Good Laboratory Practice to Good Manufacturing Practice Transitions During the Product Development
Process.” S.S. Kuwahara, J. GXP Compliance, 7 (1) 13 – 19 (2002).
 “Summary of GLP-based Warning Letters.” S.S. Kuwahara, BioQuality, 7 (8) 3 (2002).
● “Warning Letters: A Symptom?” S.S. Kuwahara , Editorial, BioPharm, 15 (3) 74 (2002).
●
“Quality Assurance and Quality Control for Viral therapeutics” S.S. Kuwahara in Manufacturing of Gene
Therapeutics, G. Subramanian (ed.) Kluwer Academic/Plenum Publishers, New York & Boston, 2002, pp.
169 – 200.

“Limulus Amebocyte Lysate Assay” S.S. Kuwahara in The BioPharm Guide to Bioanalytical Methods, BioPharm
Suppl., (Dec., 2001) pp. 33 – 34.
 “Microbiological Based Statistical Sampling” S.S. Kuwahara in Microbiology in Pharmaceutical Manufacturing,
R. Prince (ed.) PDA, Bethesda, MD & Davis Horwood International, Surrey, UK (2001) pp. 485 – 504.

“ OOS Events in Y2K: A warning letter summary” S.S. Kuwahara, BioQuality 6(1) 4 (Jan., 2001).

“Tutorial: System Suitability Testing.” S.S. Kuwahara, BioPharm, 11, (9) 65 – 66 (Sept., 1998).
 “Tutorial : Analytical Standards and Controls.” S.S. Kuwahara, BioPharm, 11, (4) 57 - 58 (Apr., 1998)

“The Future of Quality Control for Gene and Cell Therapies,” S.S. Kuwahara, BioPharm, 10, (9) 64 -65 (Sept.,
1997).

“Outlier Testing: Its History and Application,” S.S. Kuwahara, BioPharm, 10 (4) 64 - 67 (Apr., 1997).

“The Barr Decision, Part 2: Its Impact on Outlier Tests, Averages, and Validation Studies,” S.S. Kuwahara,
BioPharm, 9 , (3) 40 - 45 (Mar., 1996).

“The Barr Decision, Part 1: Coping with Failing Test Results,” S.S. Kuwahara, BioPharm, 9, (1) 24-29 (Jan.,
1996) .

“Process Validation of Separation Systems," S.S. Kuwahara and J.H. Chuan in W.P. Olson (Ed.) "SEPARATIONS
TECHNOLOGY: Pharmaceutical and Biotechnology Applications." Interpharm Press, Buffalo Grove, IL, pp. 427 - 451 (1995).

"Equations for the Calculation of Factor VIII Potencies from the Results of Parallel-line Clotting Time Assays.",
S.S. Kuwahara, Hematologia, 21:91-98 (1988).

"Solubilized DEAE-Sephadex: Measurement by Laser Nephelometry of Reineckate Complexes.", S.C. Cole and
S.S. Kuwahara, Fresenius Zeitschrift F
ü r Analytische Chemie, 327: 727-728 (1987).

"The Limulus Amebocyte Lysate Test and its Application to Human Plasma Albumin Preparations.", S.S.
Kuwahara, J.W. Mehling, D.O. Huggett, and T.C. Yang, Plasma Therapy and Transfusion Technology, 6:
93-103 (1985).


"Acetyl Acetone Method for Glycine Improved by Use of Ammonium Citrate Buffer.", Scott C. Cole and Steven S.
Kuwahara, Clinical Chemistry, 30: 1260-1261 (1984).

"Prekallikrein Activator (Hagemann Factor Fragment) in Human Plasma Fractions.", S.S. Kuwahara, Transfusion
20: 229-234 (1980).

"Distribution of Polybrominated Biphenyls (PBB) Among Fractions Derived from Contaminated Human Plasma.",
S.S. Kuwahara, F. Calera, and E.S. Perry, Transfusion 20: 229-234 (1980).

"Carbohydrate Interference in Assays Based on the Periodate-coupled Thiobarbituric Acid Reagent.", S.S.
Kuwahara, Analytical Biochemistry 101: 56-60 (1980).

"Interactions Among Bovine and Human Factor VIII, Ristocetin, and DL-Poly lysine in the Induction of Guinea
Pig Platelet Aggregation.:, Steven S. Kuwahara and Michael Malik, Physiological Chemistry and Physics
11: 337-344 (1979).

"Sialic Acid Interference with the Thiobarbituric Acid Method for Measuring 3-Deoxyoctulosonic Acid.", Steven
S. Kuwahara and Mary C. Snetting, Analytical Biochemistry 100: 118-121 (1979).

"A Neuraminidase in Duck Embryo Rabies Vaccine.", S.S. Kuwahara and G.H. Burgoyne, Health Laboratory
Science 15: 201-205 (1978).

"Destruction of the Platelet Aggregation Activity of Ristocetin A.", S.S. Kuwahara and W.T. Chambers,
Experientia 34: 532-533 (1978).

"Inhibition of Bovine Factor VIII-Induced Guinea pig Platelet Aggregation by Simple Sugars and Derivatives.",
S.S. Kuwahara and Michael Malik, American Journal of Hematology 2: 173-181 (1977).

"Borate and Glycerol Inhibition of the Aggregation of Guinea Pig Platelets by Bovine Factor VIII and Ristocetin.",
Steven S. Kuwahara, American Journal of Hematology 2: 159-172 (1977).

"Long-Term Stability of a Cyanmethemoglobin Reference Standard.", Steven S. Kuwahara, and Lowell W.
Rasmussen, American Journal of Medical Technology 42:255-258 (1976).

"Effect of Anticoagulants Upon the Cyanomethemoglobin method for Hemoglobin Assay.", Steven S. Kuwahara,
Clinical Biochemistry 9: 53-54 (1976).

"Ferric Chloride Impregnated Silica Gel for Thin-layer Chromatography of Steroids.", Daniel R. Shapiro and
Steven S. Kuwahara, Clinical Chemistry 29: 1305-1306 (1973).

"Enzyme, Protein, and Nucleic Acid Content of Two Morphological Forms of Trypanosoma (Schizotrypanum) cruzi.", Stephen A. Stohlman, Steven S. Kuwahara and Betty H. Kazan, Archiv f ü r Mikrobiologie 92: 659-
665 (1973).

"Characterization of Some-Metal Ion Dithiothreitolates and Dithioerythritolates.", H.N. Po, K.D. Legg, and S.S.
Kuwahara, Analytical Letters 6: 659-665 (1973).

"Diffusion of Nutrients in a Biphasic Medium for the Cultivation of Trypanosomes.", Violet Stohlman, Gail
Mastright, Betty H. Kazan, and Steven S. Kuwahara, Zeitschrift f ü r Parasitenkunde 41: 231-238 (1973).

"Effect of Bivalent Metal Ions Upon the Acylation of sn-Glycerol-3-phosphate by Rat Brain Microsomes.", Steven
S. Kuwahara, Physiological Chemistry and Physics 4: 449-456 (1972).

"Sterols of the Brine Shrimp, Artemia salina, from Mono Lake, California.", T. Payne and S.S. Kuwahara,
Experientia 28: 1022-1023 (1972).

"Some Chemical Properties of Zinc Dithiothreitolate.", K.D. Legg, S.S. Kuwahara and H.N. Po, Physiological
Chemistry and Physics 4: 239-244 (1972).

"Effect of Long-chain Fatty Acids on Trypanosomatid Flagellates.", L.V. Cunningham, B.H. Kazan, and S.S.
Kuwahara, Journal of General Microbiology 70: 491-496 (1972).

"The Acylation of L-Glycerol-3-phosphate by Microsomes from Rat Brain: Effects Arising from the Properties of the Reaction Medium.:, S.S. Kuwahara, Journal of Neurochemistry 19: 641-651 (1972).

"Occurrence of a 5,7-diene Sterol in Leishmania donovani.", S.S. Kuwahara, L.J. Pinto, and B.H. Kazan, Journal of General Microbiology 66: 375-378 (1971).

"Barbital as a Buffer in Serum Alkaline Phosphatase Determinations.", S.S. Kuwahara, Clinical Chemistry 17:
1214-1215 (1971).

"The Gradient Elution Chromatography of S-Palmityl-Coenzyme A.", S.S. Kuwahara, Organic Preparations and
Procedures 2:45-50 (1970).

OTHER PRESENTATIONS :
1. ”Use of Simple Statistical Tools in the QC Laboratory.” A workshop presented at: “Statistical Analysis Tools for the QC Laboratory” Institute for International Research, Alexandria, VA, August 13 – 14, 2001.
2. “Overview of Recent 483s and Warning Letters.” and “Qualification of Analytical Instruments.” Conference on
Laboratory Equipment Qualification and Validation. Institute of Validation Technology, London, UK, May
24 – 25, 2001.
3. “Implementing Statistical Methods for Annual Product Reviews.” S.S. Kuwahara, A workshop presented at the
Annual Product Reviews Conference, Princeton, NJ, May 14 – 15, 2001.
4.“The Next Step: What to Do After the Initial Laboratory Investigation.” S.S. Kuwahara, A Workshop presented at the FDA Survival Summit: Strategies to Ensure Quality and Compliance. International Business
Communications, San Diego, CA. December 11 – 13, 2000.
5. “Assay Development and Validation and the Management of OOS Results.” S.S. Kuwahara (Conference
Chairperson), 4 th Annual Analytical Methods Validation Conference, Institute for International Research,
Princeton, NJ. December 4 – 6, 2000.
6. “Develop Effective Laboratory OOS Standard Operating Procedures and Applying Statistical Concepts to OOS
Results.” S.S. Kuwahara, Conference on Investigating Out-of-Specification (OOS) Test Reults, Institute for
Validation Technology, Dublin, Ireland. September 26 – 27, 2000.
7. “Step 2: Going Beyond the Simple and Extending the Laboratory Investigation.” S.S. Kuwahara, A Workshop presented at the Conference on Investigating Out-of Specification (OOS) Test Results. Institute for
International Research, Philadelphia, PA. July 24 – 26, 2000.
8.
“Raw Material Control for Gene Therapy.” S.S. Kuwahara, Presented at the conference on Raw Materials and
Contract Services for Mammalian Cell Products. Williamsburg BioProcessing Foundation, St. Louis, MO,
June, 2000.
9. “Statistical Analysis Tools for the QC Laboratory.” S.S. Kuwahara and D.A. Milikien, Short course presented for the Institute for International Research. Philadelphia, PA, May, 2000.
10. “Investigation of Out-of-Specification Results.” S.S. Kuwahara, Short course presented for the PDA Training and Research Institute, Irvine, CA, May, 2000.
11. “Assay Development and Validation.” S.S. Kuwahara, lecture presented at University of Maryland, Baltimore
County, course on “GMP for BioTech Processes.” April, 2000.
12. “SOPs for Laboratory Investigations of OOS Results.” S.S. Kuwahara, presented at the Conference on
“Investigating Out-of-Specification (OOS) Test Results.” Institute for Validation Technology, Philadelphia,
March, 2000.
13. “Statistical Considerations for Setting Specifications.” S.S. Kuwahara, Workshop presented at the Conference on
“Setting Specifications for New Drug Substances and Dosage Forms.” Institute for International Research,
Miami, FL, February, 2000.
14. “Small Companies and Contract Testing Laboratories: Your Needs and Their Needs”, S.S. Kuwahara, in
Compliance Strategies for Small and Virtual Companies, S.S. Kuwahara, Moderator, PDA National
Meeting, Washington, D.C., December, 1999.
15. “Statistics for Out-of-Specification Test Results.” S.S. Kuwahara, presented at the Conference on Out of
Specification Test Results. Institute for International Research, Washington, DC, November, 1999.
16. “Virus Assay Methods: Accuracy and Validation,” S.S. Kuwahara, A.J. Darling, J.A. Boose, J.A. Spaltro, presented at the 3 rd Annual Analytical Methods Validation conference by the Institute for International
Research, Philadelphia, October, 1999.
17. “System Suitability Testing,” S.S. Kuwahara, presented at the Barnett/Parexel conference on Equipment
Qualification and Monitoring. September, 1999.
18. “Raw Material Control for Gene and Cell Therapy,” S.S. Kuwahara, presented at BioEurope, Cambridge,
September, 1999.
19. “Auditing from the Auditor’s Point of View,” S.S. Kuwahara, presented at BioEurope, Cambridge, September,
1999.
20.
“ Statistics for Out-of-Specification Test Results” S.S. Kuwahara, a workshop presented at the Conference on
Out-of-Specification Test Results. Institute for International Research. Philadelphia, July, 1999.
21. “GMP to GLP Transitions in the Clinical Supply Process” S.S. Kuwahara, presented at PARCS (Pacific Area
Region Clinical Supply) Meeting, June, 1999.

22. “Raw Material Control for Gene and Cell Therapy.” S.S. Kuwahara, Raw Materials and Contract Services. presented by the Williamsburg BioProcessing Foundation, St. Louis, MO, May, 1999.
23.
“Quality Control - Incoming Materials.” S.S. Kuwahara, GMP Workshop, International Society for
Hematotherapy and Graft Engineering (ISHAGE), Phoenix, AZ, April, 1999.
24. “Coping with Out-of-Specification Test Results.” S.S. Kuwahara, Course taught at the PDA Training and
Research Institute, Baltimore, MD, April, 1999.
25. “Managing Deviations: How to Define, Investigate and Document Process Deviation Events.” S.S. Kuwahara and J.E. McEntire, Pre-conference Workshop, Second Annual Analytical Methods Validation for the
Bio/Rx Industry Conference. Washington, DC; October, 1998.
26. “Methods to Demonstrate Comparability,” S.S. Kuwahara, “Comparability: The Latest Regulations Analytical
Methods, and Strategies” MA BioServices/BioReliance Autumn Symposium, San Francisco and Seattle,
October, 1998.
27.
“Investigation of Out-of-Specification Results.” Steven S. Kuwahara in “Therapy for Products and Processes:
Coping with Failure.” S.S. Kuwahara (chair) WorldPharm 98, Philadelphia, PA, September, 1998.
28.
“Quality Control of Cell Therapy Products.” S.S. Kuwahara, presented at BioEurope ’98, G. Subramanian, chair., Queens’ College, Cambridge University, Cambridge, September, 1998.
29.
“Outlier Tests and Other Considerations When Reviewing Out-of-Specification Results.” S.S. Kuwahara, presented at: ”Therapy for Products and Processes: Coping with Failure”. S.S. Kuwahara (chair) BioPharm
Conference ‘98, San Francisco, May, 1998.
30. “ Assay Validation” and “Design Control” presented at: “Drug, Device, Biologics: Testing for Safety and
Effectiveness.” S.S. Kuwahara, Regulatory Affairs Professionals Society, Baltimore, MD, March, 1998
31. “Chromatographic System Suitability Public Workshop: Validation Topics Were the Real Topics of Discussion.”
Meeting Notes, Steven. S. Kuwahara, BioQuality 2: (7) 2 (1997).
32. “The Barr Decision from an Analyst’s Point of View.” Steven S. Kuwahara, Session 4A, “BioProcessing: Quality
Control: Beyond the Basics.” S.S. Kuwahara (Chair) BioWest, October, 1995.
33. "Validation of Analytical Methods Which Support Biopharmaceuticals." Steven S. Kuwahara, Sessions 9B &
10B," BioAnalytical (A Tutorial Workshop) Biopharmaceutical Test Approaches: Raw Materials to
Finished Product." J.E. McEntire (Chair) BioEast, January, 1995.
34. "Procedures for the Validation of Chemical and Biochemical Assays of Biopharmaceuticals." S.S. Kuwahara,
Seminar on "An Overview of Analytical Laboratory Techniques for the Control of Biopharmaceutical
Products." AAI Seminar Series, September, 1994.
35. "A Source of Error in the Calculation of Factor VIII Potencies from Parallel-line Clotting-time Assays.", S.S.
Kuwahara, Annual Meeting of the Federation of American Societies for Experimental Biology, April,
(1985), Federation Proceedings, 44: 1845 (1985).
36. "Membrane Sterility Testing of Enzyme-Treated Samples.", Larry W. Gee, W.P. Olson, and Steven S.
Kuwahara, Annual Meeting of the Parental Drug Association, November, (1984).
37. "Laser Nephelometric Method for the Measurement of Dextran in Albumin Solutions.", S.C. Cole, W.P. Olson, and S.S. Kuwahara, 19th Am. Chem. Soc. Western Regional Meeting, October, (1983).
38. "Agarose Gel Electrophoresis of Albumin;", Steven S. Kuwahara and Y.C. Hong, Blood Products Advisory
Committee Workshop on the Molecular Integrity of Plasma and Cell Derived Products, Office of Biologics,
FDA, DHHSS: Vol. I, pp. 91-100, (1982).
39. "Williams B Factor Deficiency - A New Coagulation Factor Deficiency." D.A. Leichtman and S.S. Kuwahara,
Clinical Research 27: 639A (1979).
40. "Drug Metabolism: from Microbe to Man.". D.V. Parke and R.L. Smith (eds.) A Book Review by S.S.
Kuwahara. Quarterly Rev. Biology 53: 474 (1978).
41. "Polybrominated Biphenyls (PBB) in Fractions Prepared from Contaminated Human Plasma.", S.S. Kuwahara,
F. Calera, and E.S. Perry, 176th Am. Chem. Soc. National Meeting, September, 1978.
42. "Prekallikrein Activator (PKA) in Clinically Useful Protein Fractions Derived from Human Plasma.", S.S.
Kuwahara, 176th Am. Chem. Soc. National Meeting, September, 1978.
43. "Interactions Among Bovine Factor VIII, Ristocetin, and Poly-lysine in the Induction of Guinea Pig Platelet
Aggregation.", M. Malik and S.S. Kuwahara, 175th Am. Chem. Soc. National Meeting, August, 1977.
44. "Characterization of Some Precipitates of Metal Cations with Dithiothreitol and Dithioerythritol.", K.D. Legg,
H.N. Po and S.S. Kuwahara, 8th Am. Chem. Soc. Western Regional meeting, October 1972.

45. "The Kinetic Mechanism of Sheep Liver Sorbitol Dehydrogenase.: J.E. Deolden and S.S. Kuwahara, 7th Am.
Chem. Soc. Western Regional Meeting, October 1971.
46. "Cholesterol, the Major Sterol of the Brine Shrimp, Artemia salina.", T.M. Payne and S.S. Kuwahara, 7th Am.
Chem. Soc. Western Regional Meeting, October 1971.
47. "Trypanosomicidal Activity of a Marine Algal Extract.", L.V. Cunningham, S.S. Kuwahara and B.H. Kazan, 5th
Am. Chem. Soc. Western Regional Meeting, October 1969.
48. "Cell-free Alkaline Phosphatase and Other Enzymes Active in Sea Water.", R.B. Hanson, S.S. Kuwahara, and J.
Kim, 5th Am. Chem. Soc. Western Regional Meeting, October, 1969.
49. "Effect of Glycerol Ether on Bacterial Luminescence.", J. Kim and S.S. Kuwahara, 69th American Society for
Microbiology Annual Meeting, May, 1969. Bacteriological Proceedings, 30 (1969).
HONORS:
Award of Merit, Long Beach Heart Association, 1969
National Institutes of Health Special Research Fellowship, National Institute of General Medical
Sciences, 1971-1973.

BioPharm Best Article Award for “The Barr Decision, Part 1 and Part 2”, BioPharm 9: (1) & (3), 1996.
Awarded 14 May 1997.