Practical solutions for high-potency OSD development: The view from Bourgoin

Challenge: Ensuring supply chain security through dual sourcing

Maintaining a secure supply chain for high-potency APIs is essential to ensure product availability, yet dual sourcing strategies often bring their own complexities. This was a concern for a customer with an orphan drug in development. Relying on a single supplier presented a risk of supply disruptions, which could lead to costly delays. To avoid this, the Bourgoin team employed a dual sourcing strategy, using compaction simulation to evaluate and validate the properties of drug substances from two suppliers. Through careful analysis of particle size distribution and flow properties, they ensured both sources met rigorous quality standards. This approach helped safeguard the customer’s supply chain and regulatory compliance, supporting product availability across key markets.

Another customer faced a similar challenge when scaling up production of a film-coated tablet. Here, it was essential to confirm that a secondary supplier met both clinical and commercial quality standards. The Bourgoin team used predictive simulation tools to assess mechanical properties and consistency across suppliers, enabling the customer to confidently adopt a dual sourcing strategy and further strengthen supply chain reliability.

Challenge: Achieving consistent product quality in lubrication processes

As companies scale high-potency OSD products, ensuring blend uniformity and maintaining tablet properties like hardness and dissolution rates are crucial for consistent quality. This was the challenge facing a customer that needed to scale up its lubrication process. To maintain blend and tablet attributes, the Bourgoin team employed a scaling approach based on the Froude number and lubrication length scale, supported by the Styl’One™ Evolution compaction simulator. The Froude number, which helps balance the effects of gravity across different production scales, and the lubrication length scale, which optimizes mixing for specific materials, enabled precise control over blend uniformity and tablet quality. By comparing this method with traditional techniques, the team provided a tailored solution that allowed the client to achieve uniformity and quality as production volumes increased, enabling a smooth transition from lab to commercial scale.

Challenge: Scaling granulation processes while maintaining granule consistency

Scaling dry granulation processes can be particularly complex, as differences between lab-scale and pilot-scale equipment can introduce variability in granule properties like particle size distribution and flowability. For a customer facing this challenge, the Bourgoin team conducted a comparative analysis using the Gerteis Mini Pactor as a benchmark for pilot-scale operations. They evaluated several lab-scale milling technologies to identify the one most closely matching the pilot-scale’s target properties. This analysis allowed the team to minimize material waste, maintain granule consistency, and reduce production delays, ensuring a reliable path from R&D to commercial production.

The strategic value of European expertise in high-potency OSD production

For pharmaceutical companies targeting European markets, having an advanced OSD facility in the region is a strategic and operational imperative providing several advantages:

• Proximity to European regulatory bodies and access to qualified persons (QPs) for batch release streamline market entry and regulatory compliance.
• Specialized expertise in scaling and quality assurance, combined with knowledge of the European market, minimizes logistical complexities and enhances supply chain resilience.
• Shorter lead times and reduced shipping complexities help ensure that high-potency products reach patients more efficiently and with lower risk of supply disruption.

For companies developing high-potency OSD products or aiming to expand in Europe, these advantages translate to faster access to patients, streamlined pathways to market, and greater assurance of quality and reliability across the development process.