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Parsons has experience with the following types of biologics development facilities.
Basic Research/Pre-clinical: These facilities may consist of cell banking, r-DNA techniques, cell line characterization, and product identification followed by manufacturing process development, purification, formulation and stability testing. Manufacturing equipment may include spinner flasks, hollow fiber bioreactors, packed bed reactors, wave bioreactors, and small stirred tank reactors to produce milligram quantities of product.
Small-scale Facilities for Phase I/II Clinical Materials: In these facilities, some of the same activities as above repeated with emphasis on manufacturing process development. Equipment is of larger size to produce sufficient material (gram quantity) to carry out Phase I or Phase II clinical trials.
Bench-scale Facilities for Phase II/III Clinical Materials: In these facilities, the process is further refined in larger equipment (1 to 50 liter bioreactors). A sufficient quantity of material is produced (10 to 100 gram quantity) for use in Phase II or Phase III clinical trials.
Pilot Scale Facilities for Phase III and Early Market Production: In these facilities, the manufacturing process is finalized and the scale is further increased (10 to 2,500 liter bio-reactors) to produce sufficient quantities of material for Phase III or early market requirements. Generally, it is advisable to use production size equipment at this stage if possible. Changing the size for later production may require significant re-testing.
Commercial Scale Facilities: In these facilities, sufficient scale-up information is available from the pilot plant. Some pilot plants are production size since, in the past, the FDA has required that the production equipment should not vary much from clinical phase III to commercial scale. For bacterial fermentation, this may involve very large fermentors, reaching 100,000 liters or more. In the case of mammalian cell culture, 3,000 liter perfusion bioreactors and 10,000 to 20,000 liter batch reactors are being designed. The support systems for these large bioreactors also increase dramatically, and the design of the support systems such as media and buffer preparation, CIP, SIP, WFI, clean steam, and other utility loads becomes very important.
In order to support above facilities, additional facilities are required that may be on site or off site. These may include:
- Analytical labs
- Biology labs
- Clinical material preparation areas (filling, lyophilization, packaging, etc.)
- Clinical trial management group
- Test animal facilities
- Toxicology
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