Good Manufacturing Practice (GMP)
Vista’s laboratories were designed to meet the Good Manufacturing Practice (GMP) requirements for the production and purification of biologicals.
CELL CULTURE AND BIOREACTOR
Vista Biologicals upholds stringent standards in the maintenance of stationary and spinner cultures within our facilities. These cultures are carefully preserved in humidified carbon dioxide incubators to ensure optimal conditions for growth and viability.
To accommodate large-scale projects, we proudly offer 50 liter and 250 liter single-use animal cell bioreactors that meet GMP validation standards. These bioreactors are designed with the utmost attention to detail and enable a fully disposable workflow. Equipped with precise control systems, including temperature regulation, stirring, aeration, pH monitoring, dissolved oxygen management, and culture volume control, our bioreactors offer versatility in supporting various production methods such as batch, long-term perfusion, or continuous culture.
For the efficient recovery of cells and cell products, we have invested in cutting-edge micro- and ultra-filtration equipment. In addition, our extensive range of low and high-pressure liquid chromatography equipment ensures effective purification processes.
The bioreactor suites are specifically designed to meet the Good Manufacturing Practices (GMP) requirements for the production of biologicals. We have over 4,800 square feet of controlled access laboratory space dedicated to the support of fermentation. The air within the suites is maintained under positive pressure and undergoes HEPA filtration, ensuring a minimum Class 100,000 cleanroom environment. This level of cleanliness and controlled access guarantees the integrity of the biological processes taking place.
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, and a dry heat oven for depyrogenation.