Commercial API

Commercial API

From raw material sourcing to distributed drug product we provide a total supply chain for your drug.

Our focus is to deliver Quality, On Time, In Full – QUOTIF.

We manufacture: small molecules; peptides and proteins; from gramme to tonne scale. Our experienced process development chemists rigorously develop and challenge the processes, determining process controls, identifying impurities, ensuring their control and determining their purge and fate characteristics. The development cycle is completed with process validation in preparation for final regulatory approval of the process.

Facilities

We have a range of facilities delivering grammes to multi tonne scale intermediates and API for clinical and commercial requirements. These include:

  • Large Scale API Manufacturing Facilities
  • Kilo Labs for Rapid Delivery of First In Human Supplies
  • Contained Facilities for the Manufacture of Potent and Cytotoxic Compounds
  • Class 10,000 Facilities for the Manufacture and Purification of Peptides
  • Chromatographic Equipment for Rapid Purification
  • Micronisation Equipment

As part of our suite of services linking API manufacture to formulation and drug product manufacture we micronise from gramme to tonne scale. The microniser is located within containment facilities providing containment to 1 microgramme/m3.

A wide range of particle distributions can be achieved including provision of material suitable for use in inhalers.

The full range of particle sizing services is provided through:

  • Particle Size Determination
    • Dry Powder
    • Wet Dispersion
  • Hot Stage Microscopy with Photography
  • DSC
  • XRPD

In combination with our extensive capabilities in solid state services, we design the particle that you want for the product that you want.

Analytical

All of our manufacturing activities are underpinned by our powerful analytical capabilities: analytical method development and validation; impurity identification; stability studies.

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