Improved peptide analytical technologies and the impact on process development
The regulations controlling the use of synthetic peptides as therapeutics has changed significantly over the last number of years with peptides now being viewed as closer to small molecules in terms of process control, structural characterisation and individual impurity limits. In parallel to the increased regulatory requirements, advances in analytical technologies have led to an increased scrutiny of therapeutic peptides, making the understanding and control of individual impurities formed in the peptide manufacture process, critical.
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Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.