Contract Manufacturing Services

 

Services

We offer a range of services and solutions to meet your total manufacturing needs, from raw material sourcing and process scale-up, through to product for market and warehousing and distribution.

  • Raw material sourcing and supplier validation

  • Up scaling of product manufacture from laboratory to
    commercial quantities

  • Sterile filtration of liquids

  • Aseptic liquid fill and finish

  • Freeze and vacuum drying

  • In process and final product testing

  • Labelling and packaging

  • Warehousing, pick, pack and dispatch

  • Stability studies

  • Support with Process documentation 

  • Support with Process development and technical transfer

Technologies

Talk to us today about our range of manufacturing:

  • Reagents

  • ELISA

  • ELONA

  • PCR

Individual assay components to complete ready-to-use diagnostic kits

  • Manufacture of products to GMP standards

  • In process and final product testing based on agreed protocols

  • Turnaround time: Dependent on technology transfer, sourcing and supply of raw materials, complexity of design and scale of manufacturing

  • Additional services: Component and kit labelling, assembly, packing and shipping of goods

Microplate Coating Services

Standard immunological 96-well microtitre plates.

  • Capacity: 16,000 plates per week

  • Turnaround time: 7-14 days depending on volume, packaging and testing requirements

Finished ELISA Diagnostics test kits contract manufacture

ELISA Kits

Manufacturing, packaging and quality control release for research and diagnostic applications.

  • Turn around time depends on kit volumes and complexity and testing required.

  • Typical turn around for 400 kits x 30 plate (12,000 microtitre plates, 1 million tests) is 6-8 weeks

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Liquid Formulation and Dispensing
Aseptic liquid dispensing in a dedicated ISO Class 5 dispensing suite or laminar flow.

  • Batch Size: Up to 1000 L

  • Dispense volume range: 1 microlitre - 5 litres

  • Capacity: 50 - 2,500 bottles/vials per day, depending on fill volume and product

  • Steam sterilisation equipment with a capacity of 0.5 m3

  • Dry sterilisation equipment with a capacity of 1000 – 4000 vials (1 - 10 mL)

  • Container types: IV bag, bottle (screwcap; 0.05 - 5 L), glass/plastic tubes (screw/flip cap; 0.1 - 50 mL), glass vials (Stopper&crimp/screw cap; 0.1 - 5 mL), PCR and bioassay plates (0.1 - 1mL).

Freeze drying

Lyophilisation (Freeze Drying)
Custom dispense, lypholization and labeling service.

  • Batch Size: Up to 2,500 vials

  • Vial Size: 1 ml – 4 ml

  • Turnaround time: 5 – 10 days, depending on volume, cycle duration and services required

Vacuum Drying
Microtitre plate drying.

  • Capacity: 16,000 microtiter plates per week

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Product Labelling and Packing
Component and kit labelling, assembly, packing and shipping of goods.

  • Sealed aluminium packaging

  • Sealed capping

  • Microtubes and bottles

  • Labelling

  • Assembly and final packing

Additional services

Raw Material

  • Antibody - HRP Enzyme Conjugation

  • Batch Size: 1 mg - 50 g

  • Buffer exchange dialysis

  • Size exclusion analysis

  • Turnaround time: 2 - 4 weeks

    NOTE: no chromatography purification

  • Product Release Testing

  • Stability Testing

  • Warehousing

  • Distribution