GMP Peptide Manufacture - Early Phase
We are a reliable partner for GMP peptide manufacture to support early phase clinical programmes. We take a robust project management approach to the delivery of development manufacturing campaigns, and our facilities are both MHRA inspected and certified.
Collaborative and Cohesive
We value collaborative working and take a robust project management approach. We create a project team, bringing together a Project Manager and experts from our chemistry and analytical groups. This team stays with the project right the way through the development and manufacturing phases, to ensure continuity throughout the project’s duration.
Ensuring a Smooth Transition to Manufacture
We take a “fit-for-purpose” approach to process development. As process knowledge increases with time, development is refined so that we can manufacture API in line with the demands of the Clinical Phase.
Support Every Step of the Way
We have 180 analysts across the Almac Group, who can support you throughout the peptide manufacturing process. They can assist with method development and validation, QC release of raw materials and final API, and stability testing under ICH conditions. We also have experience in the testing of drug products, as well as drug substances.
Our Proven Track Record
We have successfully worked with academic groups, biotechs and large pharma companies in GMP peptide manufacture across UK, Europe and USA. Consequently, a wide variety of peptides have been successfully manufactured. Specifically, our strong track record covers the manufacture of peptide cocktails for vaccines and long peptides, with several examples of GMP products over 70 amino acids in length. We even created the world’s first peptide in excess of 100 amino acids.