STEVEN S. KUWAHARA, Ph.D.
GXP BioTechnology LLC
PMB 506, 1669-2 Hollenbeck Avenue
Sunnyvale, CA 94087-5402
Tel. & FAX (408) 530-9338
e-mail: stevekuwahara@yahoo.com
Website: www.gxpbiotech.org
SUMMARY
An experienced scientist knowledgeable in all facets of small molecule and biopharmaceutical drug
development including assay development; preclinical product development and assessment; cGMP
manufacturing of clinical materials, APIs, and final products; regulatory submissions; and quality
systems auditing and management. A leader for resolving problems and troubleshooting complex
situations related to development, manufacturing, regulatory affairs, quality assurance, and quality
control of biopharmaceuticals.
PROFESSIONAL EXPERIENCE
GXP BIOTECHNOLOGY LLC, Sunnyvale, CA
2004 to present
Managing Director
Provide consulting services in the areas of assay and product development, regulatory affairs,
GLP and cGMP to biopharmaceutical companies, contract manufacturers and testing
laboratories. Provide training in these areas as well as general quality management including
Six Sigma and process control.
You may review current activities given in my website: www.gxpbiotech.org.
TITAN PHARMACEUTICAL CORP., South San Francisco, CA
2001 to 2004
Director of Quality Control and Assay Development
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Responsible for corporate activities related to the contract manufacturing of products.
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Responsible for selecting and auditing of contract testing and manufacturing
laboratories.
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Review, approve, and monitor assay development, validation and execution at contract
testing laboratories.
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Responsible for GLP, GMP, and other regulatory interactions with contract
manufacturing and testing organizations.
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Responsible for reviewing manufacturing and testing practices of contractors and
certifying the releasability of manufactured products from contractors and suppliers.
KUWAHARA CONSULTING, Sunnyvale, CA
Principal
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General QA/QC issues related to the development or manufacture of
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2000 to 2001
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biopharmaceuticals
Auditing of internal departments, contractors and suppliers.
Validations of assays, manufacturing processes, cleaning processes, virus removal
methods.
Stability and sterility studies
Technical writing, including the preparation of submissions and organization of
documentation systems.
BIORELIANCE CORP., Rockville, MD and Sunnyvale, CA
1999 to 2000
Director of Assay Validation
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Responsible for the development and management of the corporate assay validation
program, with emphasis on Biological Assays, including PCR testing on viruses.
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Responsible for providing statistical support to clients and internal scientists.
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Represented the company by making quality-related presentations to various groups
and organizations.
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Provide technical support to Sales and Marketing personnel and, upon request, to
clients.
SYSTEMIX, Inc., Palo Alto, CA
1996 to 1999
Director of Quality Control
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Responsible for developing and maintaining the quality control program for a stem
cell based biologic product and a gene therapy based product.
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Provide quality control support for regulatory submissions and clinical trials.
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Provide quality control support for operations in a division located in France.
ALPHA THERAPEUTIC CORPORATION, Los Angeles, CA
1995 to 1996
Principal Scientist, Methods Development and Validation Department
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Supervise or personally conduct assay development and validation studies related
to blood proteins.
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Develop and write policies related to assay validations, assay transfers and raw
material management.
PYRAMID LABORATORIES, Costa Mesa, CA
1995
Technical Director
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Supervise and conduct assay development and validation studies.
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Supervise and conduct preparation and certification of standards and control
preparations.
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Design and conduct stability studies for client samples.
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Provide advice and counseling on quality control and quality assurance matters
to clients.
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Serve as a contact person to discuss client's needs and Pyramid's laboratory
capabilities in the area of biochemical analysis.
BAXTER HEALTHCARE CORPORATION
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1982 to 1995
Immunotherapy Division, Irvine, California
Manager of Quality Systems Operations
1992 to 1995
Manager of Validations: RA/QA Dept.
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Responsible for the management of Quality Systems Operations in regard to a cell
selection device; performed internal and external audits.
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Reviewed, planned, and approved assay, process (including virus reduction), and
software validation studies.
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Responsible for QA and QC in the division.
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Assisted in the preparation of device-related regulatory submissions for the U.S.
and Europe.
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Assisted with European submissions for the licensing of monoclonal antibody
derived and recombinant DNA derived proteins.
Hyland Division, Duarte, CA
1990 to 1992
Manager of Test Technology, Quality Control Department
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Managed an analytical development and special testing laboratory.
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QC input for process and product specifications for plasma protein products.
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QC/QA interface with international operations and regulatory affairs.
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Manager of Laboratories, Quality Control Department
1987 to 1990
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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 Control Department
1982 to 1987
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Managed the investigation of biochemical composition and properties of blood
derivatives.
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Performed and supervised assay development studies.
MICHIGAN DEPARTMENT OF PUBLIC HEALTH, Lansing, MI
1973 to 1982
Section Chief / Public Health Clinical Laboratory Scientist X
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Responsible for the administrative and scientific direction of the Chemical Testing,
Bioassay, and Research Units.
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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
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Responsible for the scientific and administrative supervision of chemical testing and
research units.
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Performed research on the importance of carbohydrate groups in platelet aggregation.
Unit Chief/Chemist 13, Research Unit, Product Analysis Section
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Responsible for the development of a clinically useful preparation of bovine antihemophilic factor (Factor VIII).
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Studies on the modification of bovine factor VIII to destroy its ability to aggregate
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human platelets.
EDUCATION
University of Wisconsin, Madison, Wisconsin
University of Wisconsin, Madison, Wisconsin
Cornell University, Ithaca, New York
Ph.D., (Biochemistry)
M.S., (Biochemistry)
B.S., (Biochemistry)
HONORS
Award of Merit, Long Beach Heart Association, 1969
National Institutes of Health Special Research Fellowship, National Institute of General
Medical Sciences, 1971 to 1973.
BioPharm Best Article Award for “The Barr Decision, Part 1 and Part 2”, BioPharm 9:
(1) & (3), 1966. Awarded 14 May 1997.
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PROFESSIONAL ACTIVITIES
Lectured and published in the areas of Quality Control and Assurance of Biologics and
Devices.
Member of the Editorial Advisory Boards of BioPharm, BioQuality and the Journal of
GXP Compliance.
Instructor in Biotechnology, University of California, Santa Cruz Extension Service.
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PROFESSIONAL SOCIETIES
1.
2.
3.
4.
Regulatory Affairs Professionals Society
Parenteral Drug Association
American Society for Quality
American Chemical Society
RECENT PUBLICATIONS
1. “Quality Control of Implantable Drug Delivery Systems,” Chapter 23, Steven S.
Kuwahara, in Bioseparation and Bioprocessing: A Handbook, Volume 2, (2nd ed.) G.
Subramanian (ed.) Wiley_VCH Verlag GmbH & Co. KGaA, Weinheim, Germany (2007)
pp. 675 – 690.
2. “The U.S. GMP Annexes: Additional Documents Needed for Dealing with the GMP;
Pharmaceutical Water and the Primary Drinking water Standards.” Steven S. Kuwahara,
Journal of GXP Compliance, 12, 16 – 21 (2007).
3. “Chinese Drug GMP: An Unofficial Translation Including Related Sections of the
Taiwanese, U.S., and ICH-API GMP.” Kuwahara, S. and Li, S.X. (eds) PDA, Bethesda,
MD, Davis Healthcare International Publishing, River Grove, IL, 2007.
4. “Political Will is the Backbone of Regulation Enforcement.” Steven S. Kuwahara,
BioPharm International, 20, (5) 70 (2007).
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PUBLICATIONS AND PRESENTATIONS
Books and Book Chapters
1. “Variability in Quality System Management, Chapter 4” Steve Kuwahara in
“Confronting Variability: A Framework for Risk Assessment,” R. Prince and D.
Petitti (eds.) PDA, Bethesda, MD and DHI Publishing, LLC, River Grove, IL,
2007, p. 91 – 116.
2. “Industrial Quality for the Start-Up Biotech Company, Chapter 17” Steven S.
Kuwahara in “Pharmaceutical Quality,” R. Prince (ed.) Davis Healthcare
International Publishing; River Grove, IL and PDA, Bethesda, MD, 2004, p. 603 –
634.
3. ”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.
4. “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.
5. “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.
6. “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.
7. “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).
Papers
1. “Understanding the Pros and Cons of Outsourcing to Developing Countries.” Steven S.
Kuwahara, BioPharm International, 20, (2), 30 – 32 (2007).
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2. “The U.S. GMP Annexes: Additional Documents Needed for Dealing with the GMP;
the Food, Drug, and Cosmetic Act.” Steven S. Kuwahara, Journal of GXP
Compliance, 11, 18 – 23 (2007).
3.. “Outsourcing to Developing Countries.” Steven S. Kuwahara, BioPharm International,
19, 74 (2006).
4. “Disposables in the Quality Control Laboratory.” Steven S. Kuwahara, BioPharm
International: Guide to Advances in Bioprocessing: Disposables.” (Suppl.) 38 –
42 November, 2006.
5. “BioTerrorism Rules for Food Components May Affect Drug Components as Well.”
Steven S. Kuwahara, Journal of GXP Compliance 10, 50 – 53 (2006).
6. “Validation of Microbiological Tests.” Steven S. Kuwahara, BioPharm International
(Suppl.) pp. 8, March, 2005.
7. “Regulatory Status of Laboratories Used in Clinical Trials.” Steven S. Kuwahara,
Journal of GXP Compliance 7 (4) 41 – 44 (2003).
8. “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).
9. “Good Laboratory Practice to Good Manufacturing Practice Transitions During the
Product Development Process.” S.S. Kuwahara, Journal of GXP Compliance, 7
(1) 13 – 19 (2002).
10. “Summary of GLP-based Warning Letters.” S.S. Kuwahara, BioQuality, 7 (8) 3
(2002).
11. “Warning Letters: A Symptom?” S.S. Kuwahara, Editorial, BioPharm, 15 (3) 74
(2002).
12. “Limulus Amebocyte Lysate Assay” S.S. Kuwahara in The BioPharm Guide to
Bioanalytical Methods, BioPharm Suppl., (Dec., 2001) pp. 33 – 34.
13. “OOS Events in Y2K: A warning letter summary” S.S. Kuwahara, BioQuality 6(1) 4
(Jan., 2001).
14. “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).
15. “The Future of Quality Control for Gene and Cell Therapies,” S.S. Kuwahara,
BioPharm, 10, (9) 64 -65 (Sept., 1997).
16. “Outlier Testing: Its History and Application,” S.S. Kuwahara, BioPharm, 10 (4) 64 67 (Apr., 1997).
17. “The Barr Decision, Part 2: Its Impact on Outlier Tests, Averages, and Validation
Studies,” S.S. Kuwahara, BioPharm, 9 , (3) 40 - 45 (Mar., 1996).
18. “The Barr Decision, Part 1: Coping with Failing Test Results,” S.S. Kuwahara,
BioPharm, 9, (1) 24-29 (Jan., 1996).
19. "Equations for the Calculation of Factor VIII Potencies from the Results of Parallelline Clotting Time Assays.", S.S. Kuwahara, Hematologia, 21:91-98 (1988).
20. "Solubilized DEAE-Sephadex: Measurement by Laser Nephelometry of Reineckate
Complexes.", S.C. Cole and S.S. Kuwahara, Fresenius Zeitschrift für Analytische
Chemie, 327: 727-728 (1987).
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21. "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).
22. "Acetyl Acetone Method for Glycine Improved by Use of Ammonium Citrate
Buffer.", Scott C. Cole and Steven S. Kuwahara, Clinical Chemistry, 30: 12601261 (1984).
23. "Prekallikrein Activator (Hagemann Factor Fragment) in Human Plasma Fractions.",
S.S. Kuwahara, Transfusion 20: 229-234 (1980).
24."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).
25 "Carbohydrate Interference in Assays Based on the Periodate-coupled Thiobarbituric
Acid Reagent.", S.S. Kuwahara, Analytical Biochemistry 101: 56-60 (1980).
26 "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).
27. "Sialic Acid Interference with the Thiobarbituric Acid Method for Measuring 3Deoxyoctulosonic Acid.", Steven S. Kuwahara and Mary C. Snetting, Analytical
Biochemistry 100: 118-121 (1979).
28. "A Neuraminidase in Duck Embryo Rabies Vaccine.", S.S. Kuwahara and G.H.
Burgoyne, Health Laboratory Science 15: 201-205 (1978).
29. "Destruction of the Platelet Aggregation Activity of Ristocetin A.", S.S. Kuwahara
and W.T. Chambers, Experientia 34: 532-533 (1978).
30. "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).
31 "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).
32. "Long-Term Stability of a Cyanmethemoglobin Reference Standard.", Steven S.
Kuwahara, and Lowell W. Rasmussen, American Journal of Medical Technology
42:255-258 (1976).
33. "Effect of Anticoagulants Upon the Cyanomethemoglobin method for Hemoglobin
Assay.", Steven S. Kuwahara, Clinical Biochemistry 9: 53-54 (1976).
34 "Ferric Chloride Impregnated Silica Gel for Thin-layer Chromatography of Steroids.",
Daniel R. Shapiro and Steven S. Kuwahara, Clinical Chemistry 29: 1305-1306
(1973).
35. "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 für Mikrobiologie 92: 659-665 (1973).
36. "Characterization of Some-Metal Ion Dithiothreitolates and Dithioerythritolates.",
H.N. Po, K.D. Legg, and S.S. Kuwahara, Analytical Letters 6: 659-665 (1973).
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37 "Diffusion of Nutrients in a Biphasic Medium for the Cultivation of Trypanosomes.",
Violet Stohlman, Gail Mastright, Betty H. Kazan, and Steven S. Kuwahara,
Zeitschrift für Parasitenkunde 41: 231-238 (1973).
38. "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).
39. "Sterols of the Brine Shrimp, Artemia salina, from Mono Lake, California.", T. Payne
and S.S. Kuwahara, Experientia 28: 1022-1023 (1972).
40 "Some Chemical Properties of Zinc Dithiothreitolate.", K.D. Legg, S.S. Kuwahara and
H.N. Po, Physiological Chemistry and Physics 4: 239-244 (1972).
41 "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).
42. "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).
43. "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).
44. "Barbital as a Buffer in Serum Alkaline Phosphatase Determinations.", S.S.
Kuwahara, Clinical Chemistry 17: 1214-1215 (1971).
45."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), 4th 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-ofSpecification (OOS) Test Reults, Institute for Validation Technology, Dublin, Ireland.
September 26 – 27, 2000.
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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 3rd 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.
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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 Clottingtime 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).
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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).
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