Intermediate and API Supplies, API, API supplies, intermediates, micronisation, micronization

Late Clinical Phase and Commercial Supply

Almac provides seamless transfer from early to late clinical phase and commercial GMP manufacture. Opportunities for process improvement will have been identified in the early phase synthesis, and process optimisation plans will be implemented as soon as appropriate to support cost effective scale-up.

Almac’s dedicated Biocatalysis team will assess the synthesis to identify opportunities to implement efficient enzyme transformations, reducing steps and improving cost and efficiency.

Our Physical Sciences Team evaluates the physical form of intermediates and products to ensure a well behaved process in the plant and product fit for formulation.

Almac also offers numerous support capabilities, including:
  • Kilo labs for rapid delivery of first in human supplies
  • Multi-purpose, flexible GMP reactor and isolation trains
  • Contained facilities for potent and cytotoxic manufacture
  • Class 10,000 facilities for peptide manufacture and purification
  • Micronisation for Particle Size Control
Drug Product is then manufactured, packaged and distributed from our site for many customers who use Almac for integrated API / DP supply.
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