Mammalian manufacture of biotherapeutics  

 

Slough is a multi-product cGMP manufacturing and development facility producing Mammalian Biopharmaceuticals. The facility is focused on the development and manufacture of therapeutic grade monoclonal antibodies and recombinant proteins.

Slough, UK

850
total people on site
24/7
operation
226,000
ft2 cGMP facilities

Biopharmaceutical development and manufacturing

 

Our UK facility is in the industrial town of Slough, located 22 miles west of central London.  Slough is a 226,000 ft2 (~21,000m2), multi-product cGMP manufacturing and development facility for Mammalian Biopharmaceuticals. The facility is Lonza’s development center of excellence for gene to GMP supply for all molecule types (including complex proteins) as well as product and process validation studies in support of Biological License Applications (Module3) for our mammalian network. The site supports manufacture for early clinical supply (Phase 1 & 2) as well as niche commercial manufacture.

The cGMP facility houses cell banking, production (fermentation and purification) and quality control laboratories. Five 1,000L disposable, single-use bioreactors (SUBs) are available including associated inoculum suites, media preparation areas and primary recovery equipment (comprising continuous centrifuge for cell removal, depth filtration, concentration and 0.2μm filtration equipment).

Lonza Slough 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 2012, the site has hosted 22 GMP / PAI inspections by the FDA and MHRA (among others) for both monoclonal antibodies and recombinant proteins. 

  • Upstream Capabilities
    • Mammalian Cell Culture Processes (CHO, NS0, Hybridoma, etc.)
    • Three inoculum labs for independent small-scale culture
    • Wave bags used to generate larger volumes of inoculum to seed production bioreactors
    • Single use production bioreactors – 5 x 1,000L
    • Media Preparation up to 1,000L Batches
    • Primary recovery – Centrifugation and Single use POD filtration system
    • Three Purification suites
    • Multiple scale Chromatographic Columns up to 450mm diameter both pre packed and on site packed
    • Post-Viral Reduction Filtration suite
    • Buffer Preparation up to 20,000L per Batch
    • Bulk-fill suite
    • Method development and Characterization
      • Method development, transfer, qualification & validation
      • Reference standard characterization and Biochemical Comparability
      • Protein and impurity characterization & elucidation of structure
      • Platform methods for impurity, purity and identification
      • Bioassay / Activity assay development, transfer, qualification & validation
    • Stability studies

Quality systems and regulatory inspections

 

Slough operates under the global quality management system which complies with internal policies as well as with national and international regulations. Since 2012, the site has hosted 22 GMP / PAI inspections for both monoclonal antibodies and recombinant proteins. Inspections included the FDA and MHRA among other regulatory authorities across the globe.