Low dose applications
HPAPI Manufacturing and low dose applications
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.
Capability for all aspects of contained processing
HPAPI product development:
- Clinical and commercial
- Micronization/jet milling and spray drying
- API powder encapsulation
Manufacturing advantage
Our manufacturing advantage
State-of-the-art containment and isolation procedures are in place throughout our development and manufacturing network, accommodating end-to-end solutions from HPAPI manufacturing to drug product. Our solid oral drug product technologies concentrate on:
- increasing fill speeds
- reducing processing time and costs
- minimizing product cross-contamination
- increasing operator safety through reducing potential exposure
- removing the risk of fire or explosion by improving the overall ease of handling
- improving product dose uniformity facilitated by highly accurate liquid fill metering
We utilize flexible high containment handling capability & facilities for a wide range of compound types and safety classifications, ranging from biologics to small molecules and can accommodate HPAPIs to OEL 0.1ng/m3.