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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.
HPAPI product development:
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:
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.