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Pre-Clinical to Clinical Supply
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Lonza operates a 65,000 square foot multi-product cGMP manufacturing facility in Slough, UK, close to London's Heathrow airport. The facility is used to manufacture therapeutic grade monoclonal antibodies and recombinant proteins, using small to mid-scale fed-batch suspension culture of mammalian cell cultures.
The UK facility has a long history of successful protein manufacture. This success is underscored by the fact that Lonza's UK location was the first multi-product licensed contract manufacturing facility to be licensed by the FDA, with its original Establishment License for the production of monoclonal antibodies first granted in 1985. Since then, regular inspections by the FDA and Europe’s MHRA have been hosted for both monoclonal antibodies and recombinant proteins.
Lonza's core capabilities have been enhanced with the recent renovation and expansion of its development labs and pilot plant. This is also linked to 12,000 square feet of office space housing quality assurance, regulatory, engineering and the sales and marketing department.
The cGMP facility houses cell banking, production (fermentation and purification) and quality control laboratories. Contained within the two fermenter halls are numerous airlift and stirred bioreactors with a wide range of manufacturing capacities (up to 2,000 liters) able to handle pre-clinical and early clinical supply. Disposable, single-use bioreactors (SUBs) are also available.
Each reactor has associated inoculum suites, media preparation areas and primary recovery equipment (comprising continuous centrifuge for cell removal, depth filtration, concentration and 0.2μm filtration equipment).
Following initial cell removal, purification is performed in one of three campaign dedicated suites. These suites are capable of handling process yields from a few grams to multi-kilograms of product. Clean room areas with dedicated staff have available highly flexible purification systems to allow a wide variety of chromatographic techniques to be applied.
Within our fast track development programs, both generic and customized fermentation and purification processes have been successfully transferred to manufacturing.
Quality control operates under cGMP standards and manages a comprehensive in-process and final product testing regime. In addition, there are environmental monitoring and raw material testing programs. Both biochemistry and microbiology departments provide continuous cover to support the production operations. Our quality control department works closely with Lonza's assay development group on the validation and introduction of new assay methods to fully support customers' needs from clinical trials to license applications and to stay ahead of the evolving cGMP environment.
Lonza' s expertise and experience in cell culture, purification process development and scale-up, coupled with the flexibility designed into the plant, ensures that our UK facility meets the widest range of customer requirements. |
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