Our Take
A podcast about manufacturing complexity is not a product announcement; Curia describes existing capabilities, not new breakthroughs.
Why it matters
Corticosteroids and hormonal therapies are decades-old APIs that remain critical to patients with asthma, autoimmune disorders, and endocrine conditions. Manufacturing these molecules at scale still requires specialized expertise in particle size control and aseptic high-potency handling—areas where CDMO partnerships determine patient access and cost.
Do this week
Biotech founders: audit your steroid or hormone API sourcing contract before Series B to confirm your CDMO can handle particle size spec and aseptic process scaling.
Curia discusses steroid API manufacturing at scale
Olivier Roux, Senior Director at Curia, appeared on Labiotech.eu's Beyond Biotech podcast (Episode 201, June 12, 2026) to discuss how contract development and manufacturing organizations (CDMOs) approach corticosteroid and hormonal API production. Corticosteroids treat asthma, autoimmune diseases, and related conditions. Hormonal therapies address diabetes and endocrine disorders. Both drug classes rely on APIs that are chemically mature but manufacturally complex.
Curia partners with startups and established pharma to solve supply constraints and simplify manufacturing workflows. The conversation covered key operational challenges: particle size control, aseptic processing protocols, and high-potency drug handling safety. Roux described these as material constraints on supply and on the ability to prepare for next-generation formulations.
Manufacturing maturity gates patient access
Corticosteroid and hormonal therapy APIs are not new molecules. Their complexity lies not in chemistry but in reliable, scalable manufacturing. Particle size directly affects bioavailability and efficacy in inhaled and systemic formulations. Aseptic processing and containment engineering determine both yield and worker safety when handling potent compounds.
For biotech founders, CDMO selection is a supply-chain decision, not a cost-cutting exercise. A partner that masters particle size specification and aseptic process control can compress timelines and reduce the risk of manufacturing delays during clinical trials or commercial ramp. Conversely, a misstep in either capability can halt product development or force expensive process redesigns at scale.
Verify CDMO particle and aseptic capabilities before commitment
Ask your prospective CDMO for published case studies or regulatory submissions (IND or BLA) demonstrating particle size consistency across multiple batches and aseptic process validation data. Do not assume that a CDMO skilled in small-molecule synthesis is equally capable in high-potency steroid containment or in the micronization and sieving workflows that control particle distribution.
If your steroid or hormone program is pre-IND, conduct a process feasibility study with your CDMO partner before committing to a long-term agreement. This step identifies bottlenecks early and prevents the discovery of manufacturing limitations during scale-up or regulatory inspection.