A growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HP APIs) – molecules that are proven to be effective at much smaller dosage levels than traditional APIs. The HP APIs are classified based on their toxicity, pharmacological potency and occupational exposure limits (OELs). These APIs are frequently characterized by complex structures requiring multi-step processes or semi-synthesis, often involving more than 10 steps.
High-containment manufacturing requires specialized approaches in facility design, equipment selection and manufacturing processes to achieve desired levels of containment, minimize operator exposure, and ensure worker protection and safety.
High Potency Manufacturing
At TAPI, our long tradition of highly potent product manufacturing dates back to the 1980s. Initially, the focus at our HP sites was on steroids and steroidal hormones; subsequently, we added oncolytic drugs, muscle relaxants (anesthesia) and drugs for pulmonary diseases (e.g., COPD and asthma). Placing patient health as a top priority, TAPI prevents any risk of cross contamination with chemical entities active at the µg (microgram) level by operating four dedicated production lines based on our four areas of focus.
Today TAPI operates four main HP sites: two in Italy, one in the Czech Republic, and one in Mexico. In addition to meeting industry needs for injectable and respiratory drugs, TAPI also has implemented lyophilization (freeze-drying) and micronization processes at commercial scale.