As regulatory starting materials have become more complex, often with multiple chiral centers, 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 tons for several of these products. These molecules become more complex over time and often contain one or more chiral centers, bringing chiral HPLC into the release specification and enabling our analysts to enhance their expertise in this area.
Read Anna Cousens’ Almac Voice now to find out more.
