Registered Starting Material Testing
As regulatory starting materials have become more complex, often with multiple chiral centres, drug developers are increasingly relying on their manufacturing partners to undertake the thorough analytical testing requirements to enable release of material into GMP manufacture.
At Almac’s large scale nonGMP manufacturing facility – Arran Chemical Company – we manufacture over forty different regulatory starting materials with an annual output of up to 60 metric tonnes for several of these products. These molecules become more complex over time and often contain one or more chiral centres, bringing chiral HPLC into the release specification and enabling our analysts to enhance their expertise in this area.
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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.