About the Authors:
Roger Brunkow is an Eli Lilly and
Company Engineering Consultant for Bio-synthetic Development and Manufacturing.
Mr. Brunkow was involved in the design, construction startup, and operation of
the first large scale biotech manufacturing facility for Biosynthetic Human Insulin
in 1980 and has been or is similarly involved with six additional facilities
for CDER and CBER products. He is a member of the American Society of Chemical
Engineers, American Society for Mechanical Engineers, and the PDA. He received
a BS in Chemical Engineering from the University of Wisconsin in 1967. He has
worked for Eli Lilly and Company for 22 years in various engineering and
production management positions.
Dave Delucia is an Engineering
Manager at Creative Ciomolecules, responsible for the design, construction, and
operation of a multiproduct, cGMP facility with separate capacity for mammalian
cell culture, bacterial fermentation. and associated purification. Mr. Delucia
received his MSME from MIT. He is founder and director of the annual ASME
course on bioprocess equipment de-sign and an advanced seminar on process
development.
Shane Haft has over eight
years' experience in the pharmaceutical and biopharmaceutical industries and
specializes in equipment and utility validation. His experience includes
project and field validation management, product evaluation, research and
development, and microbiology. Mr. Haft has been actively involved with five
facility start-up projects, in two of which he managed all validation
activities. Presently an independent consultant and president of Rocky Mountain
Compliance Specialists, Inc., Bozeman, MT, his past professional positions
include Director of Quality Assurance for BioScience Laboratories; Manager of
Validation for Synergen, Inc., Validation Specialist for Mallinckrodt Medical;
and Validation Specialist for Skyland Scientific Ser-vices, Inc.
John Hyde is president of JM
Hyde Consulting, Inc., a firm specializing in design consultation for hygienic
processing systems that are CIP cleanable. For nearly two years prior to the
formation of JM Hyde Consulting, Inc., Mr. Hyde was Senior Project Engineer
with Synergen, a biopharmaceutical research and manufacturing company in
Boulder, Colorado. His work at Synergen included design and implementation of hygienic
processing systems and the clean-ing validation programs for the firm's large
scale and clinical manufacturing facilities. From 1982 to 1992, Mr. Hyde was
Manager, Process Design, with Seiberling Associates, Inc., an engineering firm
specializing in the design of hygienic processing systems and the application
of CIP technology. He is currently finishing the manuscript for a book on CIP
technology, to be published in the last quarter of 1995. He holds Bachelor’s
degrees in Food Science and Business Administration and a Master’s degree in
Food Engineering Science from the Ohio State University.
John Lindsay serves as Manager
of Quality Assurance Technical Support for Genentech, Inc. Mr. Lindsay has over
22 years' experience in the pharmaceutical and biopharmaceutical industries. He
received his MS in Microbiology from Kansas University. Mr. Lindsay is a
certified Specialist Microbiologist SM(AAM) by the National Registry of
Microbiologists, serves as the chairperson of the Certification of the National
Registry of Microbiologists, and is co-author of PDA Technical Report No. 13,
"Fundamentals of a Microbiological Environmental Monitoring Program."
Dr. Jill Myers directs the Process
Biochemistry Group at Biogen, Inc., which is responsible for the development
and refinement of purification methods of recombinant proteins for use in human
clinical trials and commercial production. Prior to joining Biogen, she was responsible
for the Recovery Process Development Group at Repligen Corp. Dr. Myers received
a BS in chemistry from the University of California, Santa Barbara and a PhD in
Biochemistry from UCLA and was a Postdoctoral Fellow at Harvard Medical School.
Robert Murphy is a Validation
Specialist at Amgen, Inc., responsible for the validation of new processes
introduced into their licensed multiproduct manufacturing facility. He is an
active member of the PhRMA Biotechnology Manufacturing Issues Committee and has
made numerous presentations concerning cleaning validation to the PDA, PhRMA,
and the FDA. Mr. Murphy received his BS in Biochemistry from the University of
Missouri in 1988.
Dr. John McEntire holds a BS in
Biology from Texas Christian University and an MS and PhD from the University
of Houston. Following Postdoctoral studies in cellular immunology at the
University of Texas Medical Branch, he was active in purification and
characterization of several cell derived lymphokines while a staff scientist at
the Cancer Research Center, Columbia, MO. Dr. McEntire became research director
of that institution and directed programs in protein chemistry, immunology,
environmental carcinogenesis, and clinical immunology. He was co-founder of
IMBIC Corporation, a vehicle for commercialization of his patents and
properties, which then became a contract re-search organization. In 1987, he
joined Tektagen, Inc., Malvern, PA, as Vice President, where he developed and
implemented cGMP laboratories to support Biopharmaceutical regulatory testing
needs. While at Tektagen, he was recognized for novel approaches to validation
of analytical and biological methods. In 1994, he became Vice President of
Microbiological Associates, Rockville, MD, where he directs groups responsible
for bioanalytical services, hiosafety services, lot release, and process
validation services.
Karen Nichols is the Quality
Assurance Manager of Genzyme, Inc. She is responsible for all QA functions
including cGMP training, SOPs, hatch record control, validation documentation
auditing, product release, and investigations Prior to her association with
Genzyme, Ms. Nichols was the Assistant Director. QA, for ImmunoGen, Inc.
Currently attending Suffolk University Law School she received her BA in
Biology/Microbiology concentration.
Brenda Terranova is currently a
Staff Engineer at Genetics Institute, Inc. She is responsible for managing and
executing validation studies on numerous types of equipment and processes. Her
area of specialty is cleaning equipment and cleaning validation. In this role,
Ms. Terranova has lead multiple efforts in cleaning equipment selection,
cleaning process development, and cleaning validation. In previous positions,
she has supervised the transfer of technology from Development to Manufacturing,
and provided technical support for Manufacturing process operations. She holds
a BS in Chemical and Biomedical Engineering from Carnegie Mellon University and
an MS in Chemical Engineering from the University of Massachusetts at Amherst.
Jon Voss is the Senior
Manager of Validation for BIOPURE Corporation. Mr. Voss has over eight years'
biotechnology experience in the areas of validation, metrology, and automation,
serving previously as the Manager of Validation at Amgen, Inc., and the Section
Head of Validation and Metrology for Genetics Institute, Inc. Mr. Voss received
his BS in Physiology from the University of California at Davis and his MS in
Biomedical Engineering from Boston University. He is the Chairperson of the PDA
Biotechnology Cleaning Validation Committee and serves as a member of the PDA
Software Validation Committee.
Edward White is Technical Manager,
Process Validation, at Connaught Laboratories, Inc., Swiftwater, PA. He has
been involved in sterile process validation since 1978 and has been in the
startup and validation of sterile filling facilities as well as biotech and
traditional pharmaceutical manufacturing facilities. Mr. White has presented
papers on validation for ASTM, Pharmaceutical Seminars. Inc., and other organizations.
He is an ASQC Certified Quality Engineer and received a BS degree (1975) from
the University of North Carolina at Wilmington |
