Karen Tyrrell, Quality Assurance Lead at Pfizer CentreOne discusses the key considerations around the classification and handling of active pharmaceutical ingredients.
New active pharmaceutical ingredients (APIs) are being designed for high selectivity with biological targets, ultimately resulting in new compounds becoming more potent. Consequently, the manufacture of potent active ingredients and their associated drug products requires appropriate processes and expertise to reduce exposure risk to operators and to prevent cross-contamination.
Defining high potency API