The Road to GMP
Moving from the pre-clinical to clinical phase is a notoriously difficult jump, commonly known as the “valley of death” due to the number of compounds that don’t make it through. This feature focuses specifically on chemistry, manufacturing, and control (CMC) challenges, and how risk mitigation can prevent later headaches and potentially add value to the data package for the compound.
Almac develops and manufactures active ingredients and finished products from pre-clinical to commercial launch, and guides over 35 projects each year through scale up to GMP for the first time.
Download here to read more.
View Resource
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.