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GMP Peptide API

GMP Peptide API

Almac Sciences make peptides of between 2 and 200 amino acids in length – all to the highest practical purity.

Product, documentation and full analytical support to allow peptides APIs to be used in clinical trials.

Complete First In Man Package

Diverse Scales/Uniform Quality
Our solid phase Fmoc/tBu chemistry produces peptides in batch sizes from 10s mg to 0.5Kg.

Purification uses state of the art chromatography (HPLC, size exclusion, ion exchange, tangential flow filtration). Product is lyophilised and shipped for sterile fill-finish as required.
A comprehensive range of the latest analytical techniques underpin delivery to the highest quality standards

Regulatory Support
Peptide APIs are produced under cGMP conditions in modern facilities. Additional regulatory support is available for the QP release of sterile parenteral products.

Facilities & Equipment

 

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Translating science to targeted patient care
Supporting the development & supply of APIs
Clinical supply; manufacturing; packaging; distribution; QP
IVR; IWR; EDC; ePRO; Biostatistics
Product Development, Commercial Manufacturing, Packaging and Support