High Potency API Development And Manufacturing

If you're scaling a high potency active pharmaceutical ingredient (HPAPI) program, the containment and scale-up decisions you make early tend to follow you all the way to commercial supply. Curia's HPAPI capabilities cover that entire arc, from milligram-scale preclinical work through metric-ton commercial manufacturing, across 13 sites in the US, Europe, and India.

What's worth noting is the depth of containment infrastructure. SafeBridge-certified facilities, OEB4 and OEB5 handling (occupational exposure limits down to below 0.1 µg/m³), six stainless steel isolators at Valladolid, and three independent suites at Rensselaer give you options that most single-site CDMOs simply can't match. Albany handles route scouting through scale-up with Corning tubular reactors and static mixers. Rensselaer takes you to over 100 kg under full cGMP. Buffalo covers ADC conjugation and bioactivity assessment at discovery scale.

The therapeutic focus spans ADC payloads and payload-linker intermediates, oncology APIs, steroids, and hormones. Thirty years of cytotoxic compound experience backs all of it.

Contact Curia to scope your high potency program and identify the right site and containment strategy for your molecule.