Advancing corticosteroids and hormonal therapies for supply and scale

What It Covers

Olivia Ryu, Senior Director at Curia, explains how corticosteroid and hormonal therapy APIs — molecules in use for over 70 years — still require highly specialized manufacturing, dedicated segregated facilities, and end-to-end CDMO partnerships to meet growing global demand across aging populations and emerging markets.

Key Questions Answered

• •Facility Segregation: Steroid and hormone APIs require physically dedicated, segregated manufacturing plants — not just procedural separation. Although regulations don't mandate it, health authorities hold strong positions on cross-contamination risks. Companies evaluating CDMO partners should verify that steroid production occurs in standalone facilities, not shared multi-product plants, to protect regulatory submissions and patient safety.
• •Particle Size as a Clinical Variable: Particle size directly determines bioavailability, stability, and therapeutic performance in steroid APIs. When selecting a CDMO, confirm they can perform particle sizing — including milling and micronization — within the same segregated steroid facility. Splitting synthesis and particle sizing across partners introduces contamination risk and complicates regulatory filings across multiple regions.
• •Aseptic Processing for Heat-Sensitive Steroids: Many steroid APIs cannot tolerate terminal sterilization or gamma radiation, making aseptic processing the only viable route for injectable applications. The method involves sterile dissolution, filtration, and controlled crystallization under aseptic conditions. CDMOs must offer this capability within a dedicated steroid unit to produce sterile API suitable for aseptic powder-fill drug product manufacturing.
• •End-to-End Scale as Risk Reduction: Partnering with a CDMO that covers preclinical through multi-ton commercial production on the same equipment platform eliminates tech transfer handoffs between development stages. Fewer transfers mean fewer process inconsistencies, fewer regulatory gaps, and faster timelines. For steroid programs, this continuity is a direct risk-reduction strategy — not just a convenience — given the chemistry's complexity.
• •Emerging Steroid Innovation Areas: Neurosteroids capable of crossing the blood-brain barrier represent a concrete growth area, with approved applications in postpartum depression and post-stroke brain protection emerging in the last five to ten years. Selective glucocorticoid receptor modulators — designed to retain efficacy while reducing side effects — and advanced digital inhaler delivery systems requiring tighter particle size control are also active development frontiers.