Benefit from access to our fully integrated services, through all stages of development and manufacturing, from HPAPI drug substance to specialized low dose oral solid forms such as micro-dosed powder-in-capsule. Our broad capabilities and integrated approach enable you to use one partner throughout your project.
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
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.