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.
