Practical solutions for high-potency OSD development

April 24, 2025

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Pharmaceutical companies developing high-potency oral solid dosage (OSD) products often face challenges such as supply chain security and scaling manufacturing processes. These challenges are particularly critical when working with high-potency active pharmaceutical ingredients (APIs). To overcome these obstacles, a data-driven and adaptable approach is necessary, one that utilizes specialized expertise, predictive tools, and advanced technologies.

Thermo Fisher Scientific’s OSD manufacturing facility in Bourgoin, France, exemplifies how these strategies can address the challenges of high-potency OSD development. The site, an FDA-approved center for both early and late-stage development, specializes in high-potency APIs, offering capabilities in formulation development, API characterization, and clinical services to help reduce risks and accelerate time-to-market.

The Bourgoin team used the STYL'One Evo Compaction Simulator to address key challenges:

- Supply Chain Security: By using compaction simulation to evaluate drug substances from two suppliers, they ensured both sources met rigorous quality standards, supporting regulatory compliance and safeguarding the customer’s supply chain.

- Consistent Product Quality: To maintain blend uniformity and tablet properties like hardness and dissolution rates during scaling, the team employed the STYL'One Evolution Compaction Simulator, which helped optimize the lubrication process and ensured consistent product quality from lab to commercial scale.

- Granulation Process Scaling: The team also conducted a comparative analysis of lab-scale and pilot-scale operations to ensure granule consistency, minimizing material waste and production delays.

The Bourgoin facility provides a strategic advantage for pharmaceutical companies developing high-potency OSD products, particularly for those targeting European markets. By leveraging the STYL'One Evo Compaction Simulator, the site supports efficient scaling, regulatory compliance, and supply chain resilience, ensuring faster market access and greater product reliability.