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I O
R O C E S S
TECHNICAL
Suite Changeover
Involving Diverse Hosts
in Multiproduct Facilities
Kristin S. Murray, Debra K.S. Anderson, and Heidi M. Reichert
iotechnology manufacturing
space is precious and
expensive. As successful
biotechnological products
continue to proliferate,
commercial biopharmaceutical
manufacturers must be able to
establish and maintain facilities that
can nimbly respond to changes in
drug-substance production plans.
For well over 10 years, the concept
of multiproduct facilities has been
mainstream for minimizing the
cost, risk, and time associated with
bringing new products to market.
Factors including the overall cost
of manufacturing facilities, contract
manufacturing opportunities,
pipeline development needs, and
periodic limitations in capacity have
all required manufacturers to be
efficient with manufacturing suite
changeover procedures. Companies
must either use disposables in lieu
PRODUCT FOCUS: PRODUCTS OF
FERMENTATION AND CELL CULTURE
KEYWORDS: MANUFACTURING
SUITE CHANGEOVER, CAMPAIGN
MANUFACTURING, HOST CELL, RISK
MANAGEMENT/ASSESSMENT, CHO,
E. COLI
LEVEL: BASIC
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Contaminants for
Consideration
Virus, adventitious
agents (e.g.,
mycoplasma), CHO
HCP
E. coli fermentation to
CHO cell culture
Phage, endotoxin,
E. coli HCP
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Special Considerations
or other adventitious-agent contamination
during CHO cell culture manufacturing;
these agents are generally not a concern
for E. coli fermentation processes
BioProcess International
MARCH 2005
Contaminants Identified
Examples
Organic chemicals,
biological components (raw
materials, process-related
components, adventitious
agents, product and HCP
Inorganic chemicals
General
Dried materials
Product-specific assays
(immuno-based assays)
Product, product-related
impurities, and HCP
HCP, product
BioProcess International
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BioProcess International
MARCH 2005
REFERENCES
eudra.org/F2/eudralex/vol-4/pdfs-en/
anx02en200408.pdf.
4 US FDA Dept of Agriculture and
the National Advisory Committee on
Microbiological Criteria for Foods. The
Hazard Analysis and Critical Control Point
Principles and Application Guidelines.
August 1997; http://seafood.ucdavis.edu/
Guidelines/nacmcf1.htm.
5 DeSain C, Sutton CV. Risk
Management Basics. Tamarack Associates
LLC: Tofte, MN, 2000.
6 McDermott RE, Mikulak RJ,
Beauregard MR. The Basics of FEMA.
Resource Engineering, Inc.: Portland, OR,
1996.
7 AAMI. Medical Devices-Application of
Risk Management to Medical Devices. ANSI/
AAMI/ISO14791:2000, March 2001.
8 ICH. Q9 Quality Risk Management
(Draft Guidance for Industry). May 2004.
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