HPAPI Manufacturing: Low dose applications
Low dose requirements and the safe handling of highly potent compounds are key challenges in the development and manufacture of many drug products. Contained micro-dosing is often required for accurate dosing and safe drug development. HPAPI manufacturing is one of our core focus areas and we provide fully integrated services from drug substance to sterile fill / finish and specialized oral solid dosage forms inclusive of micro-dosed powder-in-capsule (PIC) or powder-in-bottle (PIB) formats.
Highly potent compounds (HPAPI) are an increasing component of today’s drug development pipeline driven by more targeted therapies and expanded oncology research. These compounds present safety challenges at all stages of development and manufacturing, and require specialized processing and protocols for the drug substances, particle engineering and finished dosage forms. We have premier experience, track record and capabilities for all aspects of contained processing:
- HPAPI product development, clinical production, and commercial production
- Micronization / jet milling and spray drying
- API Powder Encapsulation
- Parenteral drug development and sterile fill / finish