Facilities

Speke, Liverpool, UK

Manufacturing

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Packaging

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API manufacturing, spray drying,
and microbial CDMO services

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STATE-OF-THE-ART CONTRACT DEVELOPMENT & MANUFACTURING FOR FERMENTATION-DERIVED DRUG SUBSTANCES (API) AND FINISHED PRODUCTS

At our Speke, England facility, TriRx Pharmaceutical Services provides drug substance CDMO services to help develop and manufacture your active pharmaceutical ingredient (API). Located in the heart of one of the UK’s leading biopharma regions, the Speke facility offers robust human and animal health capabilities for the production of biotech API via bacterial, yeast and mammalian cell fermentation. Services available include process development and production, non-sterile liquid filling, fermentation, spray drying, coating, pre-mixing, and Speke also has an on-site analytical laboratory for extensive quality control (QC) and stability testing.

FACILITY HIGHLIGHTS

  • 320+ employees produce 99 SKUs, directly supplying more than 65 global customers
  • Process development capabilities with well-equipped, high-throughput state-of-the-art equipment for process establishment, optimization and scale-up in the field of recombinant proteins & peptides, monoclonal antibodies, and cell-based processes
  • Analytical method development capabilities
  • Manufacturing capabilities, including:
    • Biotech API upstream and downstream processing (recombinant proteins, peptides, and monoclonal antibodies)
    • Non-sterile liquid filling
    • Fermentation & downstream processing
    • API spray drying & coating
    • API pre-mixing
  • Shipping & warehousing
  • In-house QC capabilities including routine batch release testing and stability studies
  • VMD (UK Veterinary Medicines Directorate), FAMI-QS & SF/SF (Feed safety management systems), ISO 9001 approved; in compliance with EMA and FDA guidance
BIOLOGICS LIQUIDS

CONTRACT PHARMACEUTICAL MANUFACTURING

Biologics & Biotech API

  • Microbial fermentation—6,000 L fermenter
  • Cell recovery with Alfa Laval MB601 centrifuge & GEA NS5180H homogenizer
  • Downstream purification with Cytiva AxiChrom chromatography columns and Pall TFF units
  • Freeze-dried or frozen API using cold processing, product freezers, and shipment

Fermentation & Downstream Processing

  • Culture preparation utilizing independent culture suites
  • Fermentation with eighteen 150,000-, one 100,000-, four 6,000-, and one 18,000 L fermenters
  • Separation of solid phase & drying/milling to solid API
  • Membrane separation & concentration to liquid API

API Spray Drying

  • Spray drying of antibiotic & enzyme liquid concentrate using Niro automated fluidized bed spray dryers (units with 700,000 kg/year and 100,000 kg/year capacity)
  • Bulk keg packaging

API Pre-Mixing

  • Three independent premixing production areas enable the dilution of liquid and dry API with powder diluents for final product production
  • Dry API dilution using a 4,000 kg blender—automated paper bag filling, multi-product capabilities
  • Liquid API dilution using blenders & Niro Aeromatic Dryers (T8-B7-F2)—filling to plastic form-fill bags, high potency containment available, multi-product capabilities
  • Liquid API dilution using product granulation technology—filled to paper sacks

API Spray Coating

  • Coating of powder API with protective excipient layer to create final product or coating API
  • Process completed using a Bosch coater/dryer, sieve/milling, horizontal ribbon blender
  • Bag filling using an automated 25 kg filler

PACKAGING CAPABILITIES

Non-Sterile Liquid Filling

  • Formulation and filling of liquid API
  • Filling accomplished using a Serac filling machine capable of filling 100 mL to 3,000 mL bottles in an ISO8 booth
  • Labels printed and automatically applied using a laser printer; serialization capability available