What are the key takeaways from this Beyond Biotech episode?

Key insights include: **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.

What did Olivia Ryu discuss on Beyond Biotech?

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 topics include: **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..

How long is this episode of Beyond Biotech?

This episode is 27 minutes long. SignalCast provides an AI-generated summary so you can get the key insights in about 3 minutes.

Beyond Biotech

Advancing corticosteroids and hormonal therapies for supply and scale

June 12, 2026

27 min episode · 2 min read

Olivia Ryu

Episode

27 min

Read time

2 min

Topics

Health & Wellness, Relationships, Design & UX

AI-Generated Summary

Published Jun 12, 2026

Key Takeaways

✓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.

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.

Notable Moment

When a large pharma company faced an unexpected steroid API supply disruption that threatened patient access, Curia rapidly assessed the existing process, resolved impurity and yield variability issues, and simultaneously aligned regulatory documentation — compressing what typically takes years into a tight emergency timeline.

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Episode Transcript

Hello, and welcome to Beyond Biotech, the weekly podcast from La BioTech. I'm Dylan Kossain, and this is episode 201 for the podcast. Today, we're diving into the world of corticosteroids and hormonal therapies. Essential APIs that treat everything from asthma and autoimmune disease to diabetes and endocrine disorders. These molecules may be decades old, but their manufacturing remains highly complex and critical to patients worldwide. I'm delighted to welcome our guest, Olivia Ryu, a senior director at Curia. As a global leader in small molecule development and manufacturing, Curia operates a dedicated European center of excellence with four steroid specific plants, full life cycle support from lab to multi ton scale, and specialized capabilities in aseptic processing, particle size control, and high potency handling. In this episode, Olivia shares how Curia partners with both startups and big pharma to simplify steroid API challenges, solve supply issues, and prepare for next generation innovations. If you want to understand what it really takes to bring these life changing therapies to patients, stay tuned. This conversation is packed with insights you won't wanna miss. Olivier, welcome to Beyond Biotech. Thank you. Thank you for having me. Olivier, why don't we start by learning a little bit more about, who you are and how you found your way to where you are today? What's your history in the industry? Sure. So I've been in industry for for about twenty five years now. I started, straight out of school in large pharma. Started ten years, twelve years in the lab on the analytical chemistry side. I studied biochemistry at Indiana University. But the large pharma I I joined right out of school was, had a deep, knowledge base on on stairs and hormones. They were some of the originators of some of the original synthesis. Since then, I I joined Curia, on the sales side of the organization. So I'm senior director, CMO sales for North America. Tell me a a little bit about these corticosteroids. Can you maybe start by what are corticosteroids and these hormonal therapies? Sure. So corticosteroids are are medicines that either replace, regulate, or modulate hormones that naturally occur in the in the human body. So there's synthetic versions of hormones that play a critical role in inflammation, immune response, metabolism, stress. So you can think of cortisone, hydrocortisone, and things like that. Depending on on on the indication, there's oral versions of these drugs. There's also inhalers and and topical creams, which I'm sure everyone's seen in in, Walgreens, Walmart, so your local pharmacies. Steroid steroidal hormones therapies, it's kind of stepping back a little bit. They're they're it's a more broad, group of medicines. They include treatments that, influence the endocrine system for diseases like acids or, adrenal hyperplasia. They these treatments can replace missing hormones, and one of the most common use of steroidal hormones is for hormone replacement therapy, whether that be for for women in in menopause or with progesterone or as and estradiol …

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