Spotlight on stability: API and drug product testing
Stability studies are key to drug development. An integral part of any New Drug Application (NDA) is to perform stability studies on active pharmaceutical ingredients (APIs) and drug products to assess degradation and inform shelf-life prior to market release. For some programmes, further investigation is required to demonstrate stability of key raw materials, intermediates or excipients used in the manufacturing process. Anna Cousens, Business Development Manager at Almac Sciences, describes what studies need to be performed, and how, to ensure best product performance.
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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.