RANDALL G. RUPP, Ph.D. Address: 61 Fadden Road Swanton, VT

RANDALL G. RUPP, Ph.D.
Address:
61 Fadden Road
Swanton, VT 05488
Present Position:
VP Manufacturing and Process Development
Stemnion, Inc.
Education:
B.S. (1969), Biology, M.S. (1971), Microbiology;

Indiana University of Pa., Indiana, Pa.
Ph.D. (1974), Biomedical Sciences, University of Texas,

Graduate School of Biomedical Sciences, M.D.
Anderson Hospital and Tumor Institute, Houston, TX.
Post-Doctoral Fellow, (1974-1976), Battelle Memorial

Institute, Richland, WA. Immunology.
Research Associate, (1976-1978), University of Texas

Medical Branch Galveston, TX. Infection and Immunity.
Honors and Societies
James W. McLaughlin Award for Excellence in Original Research in Infection and Immunity; Rosalie B.
Hite Fellowship for Cancer Research for Original Proposal; Bausch and Lomb Science Award; Sigma Xi
Honorary Science Fraternity; High School Valedictorian; President's Award for Outstanding Achievements,
Damon Biotech; Distinguished Employee, Invitron Corp.; American Society of Cellular Biologists;
American Society of Microbiologists; American Tissue Culture Society; New York Academy of Sciences
Synopsis of Professional Experience
Stemnion, Inc. (2008-present)
Vice President, Manufacturing and Process Development

Responsible for all GMP manufacturing. Development activities include: cell culture optimization,
analytical development, cell characterization, and technologies associated with the therapeutic use of
cells in people.
Regeneron Pharmaceuticals, Inc. (1991 to 2007)
Senior Vice President, Manufacturing and Process Sciences (Jan. 2001)

Vice President, Manufacturing and Process Sciences
As Vice President of Manufacturing and Process Sciences I was responsible for the clinical
development and subsequent production of recombinant proteins. These activities included:
fermentation, upstream and downstream purification, filling, packaging, formulation development,
quality control, stability studies and day-to-day operation of the process sciences and manufacturing
facilities. I had 8 direct reports (Director of Facilities, Director of Quality Control, Director of PRP
Manufacturing (a vaccine intermediate for Merck), Director of Clinical Production, Director of
Process Sciences, Director of Pilot Plant, Director of Operations Management and Manager of
Regulatory Operations. Quality assurance, human resources and finance reported indirectly to me as
core functions. There were about 240 people in my reporting structure at the Rensselaer, NY facility
and another 33 in the pilot plant at the Tarrytown, NY facility. During my tenure in this position, I
oversaw the design and construction of three cGMP-quality facilities and one pilot plant. Most
recently was the completion of two facilities, one $30M expansion for bacterial fermentation and
one $23M expansion for cell culture.
For the intermediate vaccine product (PRP) I oversaw a successful FDA Pre-Approval Inspection
and a European Union (EMEA) inspection.
Biohybrid Technology Inc. (1990 -1991)

Vice President Research and Development
As Vice President for Research and Development I was responsible for the successful development
of an artificial pancreas. These duties included the management of 5 Ph.D.'s and 36 technicians. In
this position, I coordinated all research and development of cellular isolation, device design and pre-
clinical animal studies.
Somatogen Corporation (1989-1990)
Vice President Process Development and Manufacturing
In this position I was responsible for developing the fermentation and purification processes for
recombinant hemoglobin produced in E. coli. These duties also included the establishment of a fully
validated quality control, and analytical protein chemistry laboratory.
Invitron Corporation (1986-1989)
Vice President Cell Biology Research and Process Development
I was responsible for the scientific management of all cell culture and analytical processes. The total
staff was 105.
I was part of the design and construction of GLP/GMP laboratories.
Director, Cell Biology Research
In my initial assignment I was responsible for assembling a group of cell biologists, biochemists,
immunologists and biochemical engineers to study the mechanisms of cellular differentiation. I
managed a group of 3 Ph.D.'s and 12 technicians.
Accomplishments included the development of a number of sera-free media and serum substitutes,
analytical procedures to quantify intercellular proteins using the fluorescent activated cell sorter, and
assays to assess protein integrity, e.g. amino acid composition, carbohydrate analysis and peptide
mapping.
I also designed and coordinated the construction of the development of the pilot plant.
SmithKline Beckman (1985-1986)

Assistant Director, Cell Biology
My assignment was to establish a cell culture group to develop recombinant tissue plasminogen
activator produced form Chinese Hamster Ovary Cells. I brought in 8 people and started building
the laboratories. In addition, I was the liaison between the European organization producing tPA
and our company.
Damon Biotech (1981-1985)
Director, Cell Biology Research Process Development and Pilot Plant
The scientific goals included the optimization of growth and the expression of differentiated
functions in cultured cell. I developed sera-free media, established analytical and large-scale
purification procedures for cellular proteins. In addition, I designed and constructed cell culture
reactor vessels for research and development and coordinated the construction of instruments for
monitoring cell cultures.
Flow Laboratories (1978-1981)
Director, Research and Development
I managed a group of 2 Ph.D.'s and 5 technicians to develop immunoassays for use in detecting
antibodies in human sera to various viral antigens. Other research included the development of
methods for large-scale propagation of cultured cells and purification of their products e.g. beta-
interferon, fibrinogen, and monoclonal antibodies. We also developed a method to separate
polymorphonuclear leukocytes from monocytes in a one step gradient.
Patents
A process for increasing the expression of differentiated functions of cultured myeloma cells.
A non-protein serum substitute to increase tissue plasminogen activator synthesis in cultured cells.
A modified stirred-tank reactor for culture of immobilized cells.
Artificial Pancreatic Perfusion Device with Reseedable Matrix.
Publications
Rupp, Randall G. 1975. The Phosphorylation of Ribosomal Proteins During the Cell Cycle of Chinese
Hamster Ovary cells. Ph.D. dissertation, The University of Texas Graduate School of Biomedical Sciences,
M.D. Anderson Hospital and Tumor Institute, Houston, Texas.
Rupp, Randall G., Humphrey, Ronald M. and Shaeffer, Joseph R. 1976. Phosphorylation of Ribosome-
Associated Proteins During the Mammalian Cell Cycle: Unique Phosphorylation of a Specific Protein
During Mitosis. Biochem. Biophys. Acta, 418:81-92.
Rupp, Randall G. and Wiley, William R. 1976. Synthesis of S-100 Protein in Glial Cells: Selection of a
Contact-Sensitive Cell Line. Report to ERDA Division of Biomedical and Environmental Research.
Rupp, Randall G., Morris, James E. and Wiley, William R. 1976. Synthesis of S-100 Protein in Glial Cells:
Purification of Bovine Brain S-100 Protein and Immunological Studies. Report to the U.S. ERDA Division
of biomedical and Environmental Research.
Rupp, Randall G. and Fuller, Gerald M. 1979. The Effects of Leukocytic and Serum Factors on Fibrinogen
Biosynthesis in Cultured Hepatocytes. Exp. Cell Res. 118:23-30.
Rupp, Randall, G. and Fuller, Gerald M. 1979. Comparison of Albumin and Fibrinogen Biosynthesis in
Stimulated Rats and Cultures Fetal Hepatocytes. Biochem. Biophys. Res. Comm. 88:327-334.
Rupp, Randall G. and Geyer, Scott D. 1985. Preparation of Medium for Large-Scale Culture of Hybidoma
Cells. J. Tissue Culture Methods 8:141-145.
Rupp, Randall G. 1985. Production of Monoclonal Antibodies from Microencapsulated Hybidoma Cells.
Research Needs in Non-Conventional Bioprocesses, David J. Fink, Linda M. Curran and Billy R. Allen eds.,
Battelle Press, Columbus, OH.
Rupp, Randall G. 1985. Use of Cellular Microencapsulation in Large-Scale Production of Monoclonal

Antibodies. Large-Scale Mammalian Cell Culture, Joseph Feder and William Tolbert, eds., Academic
Press, Orlando, FL.
Rupp, Randall G., Gilbride, Kevin and Oka, Melvin S. 1987. Cellular microencapsulation for large-scale
production of therapeutic monoclonal antibodies. Large Scale Cell Culture Technology, Bjorn Lyderson,
ed. Hanser Publishers.
Tedesco, John, Ohlson, Sten and Rupp, Randall G. 1989. Evaluation of a New High Performance Liquid
Chromatography Resin for Rapid Quantitation of IgG in Cell Culture Media. Biotechnology, September.
McNabb, Sharon, Rupp, Randall and Tedesco, John. 1989. A rapid, sensitive method for the quantitation of
total DNA in cell-derived proteins. Biotechnology.
Rupp, Randall G., Tate, Emily and Peterson, Lisa. 1989. The Use of the Fluorescent-Activated Cell Sorter
to Monitor Changes in Cell Specific Productivity, Proceedings of the European Cell Culture Society.
Oka, Melvin S. and Rupp, Randall G. 1990. Large-Scale Animal Cell Culture: A Biological Perspective.
Large-Scale Mammalian Cell Culture Technology, Anthony S. Lubiniecki, ed. Marcel Dekker Publisher,
New York.
Rupp, Randall G. 1990. Factors Affecting the Commercialization of Biologicals from Cultured Animal
Cells. Handbook of Fermenter Design, Ed Byorstrum, ed.
Rupp, Randall G. and Oka, Melvin S. 1991. Science, Technology and Politics: Real Factors in Selecting a
Mammalian Cell Bioreactor. pp. 139-150., The Business of Biotechnology, From the Bench to the Street.
Dana Ono, ed., Butterworth-Heinemann, Stoneham, MA.
Lanza, R., Butler, D., Staruk, J., Faustman, D., Muller, T., Solomon, B., Rupp, R. and Chick, W. (1991).
Xenotransplantation of Bovine, Canine and Porcine Islets Without Immunosuppression.
Shapiro, L, Zhang, X., Rupp, R., Wolff, S., and Dinarello, C. (1993) Ciliary Neurotrophic Factor is an
Endogenous Pyrogen. Pp. 8614-8618., PNA, 90.
Rupp, R.G. (1994). Some Aspects of Monoclonal Antibody Production. pp. 331-344. The Pharmacology of
Monoclonal Antibodies, eds. Rosenberg, M. and Moore, G., Springer-Verlag, Berlin, Germany.
Lombardo, S., Inampudi, P., Scotton, A., Ruezinsky, G., Rupp, R. and Nigam, S. (1995). Development of
Surface Swabbing Procedures for Cleaning Validation Program in a Biopharmaceutical Manufacturing
Facility. Biotechnology and Bioengineering, 48: pp. 513-519.
Sunasara, K., Cramer, S., Hauer, C., Rupp, R., and Shoup, V. (1999). Characterization of Recombinant
Human Brain-Derived Neurotrophic Factor Variants. Archives of Biochem. and Biophysics, 372, No. 2 pp.
248-260.
Shukla, A., Sunasara, K., Rupp, R., and Cramer, S. (2000). Hydrophobic Displacement Chromatography of
Proteins. Biotech. and Bioengineering, 68: No. 6, 672-680.
Steed, DL., Trumpower, C., Duffy, D., Smith, C., Marshall, V., Rupp, R., Robson, M., (2008). Amnion-
derived Cellular Cytokine Solution, A physiological combination of cytokines for wound healing. ePlasty,
April 14th.

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RANDALL G. RUPP, Ph.D.

B.S. (1969), Biology, M.S. (1971), Microbiology;

Ph.D. (1974), Biomedical Sciences, University of Texas,

Post-Doctoral Fellow, (1974-1976), Battelle Memorial

Research Associate, (1976-1978), University of Texas

Honors and Societies

Vice President, Manufacturing and Process Development

Senior Vice President, Manufacturing and Process Sciences (Jan. 2001)

Biohybrid Technology Inc. (1990 -1991)

SmithKline Beckman (1985-1986)

Rupp, Randall G. 1985. Use of Cellular Microencapsulation in Large-Scale Production of Monoclonal

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