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Cell Culture and Fermentation
Stationary and spinner cultures
are maintained in humidified carbon dioxide
incubators. For large
scale work Vista has 140 liter and 250 liter animal
cell bioreactors. The units were designed by Vista personnel
in collaboration with Whatman Biosystems. The bioreactors
were constructed to meet GMP validation standards. Each
unit is fully sterilizable, and is controlled for temperature,
stirring, aeration, pH, dissolved oxygen, and culture
volume. All fermentors can be configured for batch,
long-term perfusion, or continuous culture production.
For recovery of cells
and cell products, we have micro- and ultra-filtration
equipment, in addition to low and high pressure liquid
chromatography equipment.
Physical Plant
The fermentation suites are specifically
designed to meet the Good Manufacturing Practices (GMP)
requirements for the production of biologicals. Currently
we have over 4,800 square feet of controlled access
laboratory space dedicated to the support of fermentation.
The suites feature sealed walls and ceilings, seamless
floors, and a minimum of Class 100,000 HEPA filtered
air maintained under positive pressure.
Support
The laboratory includes a dedicated
media / solution preparation suite, a sterilization
suite, and an analytical suite for off-line measurements,
such as glucose, lactate, ammonia, LDH, and IgG / IgM
concentration. Instrumentation for product analysis
includes an HPLC station, a Roche centrifugal analyzer,
PCR, ELISA, and electrophoresis equipment. Auxiliary
support resources include a Class 10,000 clean room,
liquid nitrogen for long-term storage of cells, a large
vacuum autoclave, a dry heat oven for depyrogenation,
and an all-glass still for production of high purity
pyrogen-free water.
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