Accelerating Clinical Timelines: On-Demand Manufacturing with Softgels Cuts Costs and Time

In an industry where speed and efficiency are paramount, pharmaceutical companies are constantly seeking innovative ways to accelerate drug development timelines. A recent breakthrough in manufacturing processes promises to significantly reduce both time and costs associated with early-stage clinical trials, potentially revolutionizing the way drugs are brought to market.

On-Demand Manufacturing: A Game-Changer for Early Clinical Development

Traditionally, Phase 1 studies have relied on fixed drug product strengths, requiring multiple formulations for different dosage levels. This approach has been time-consuming, resource-intensive, and inflexible. However, a new strategy involving on-demand manufacturing using softgel formulations is changing the game.

Guillaume Enderlin, Associate Director of Product Development at Catalent, emphasizes the importance of integrating manufacturing considerations early in the development process. "Go-to-clinic strategy must be embedded from the earliest stages of preclinical development, not just considered at the point of manufacture," Enderlin states. "Delays or overlooked risks in early stages can cascade into costly setbacks later."

The on-demand manufacturing approach combines formulation development, clinical manufacturing, regulatory support, and clinical testing into a single adaptive program. Unlike traditional methods, this strategy allows for the manufacturing of dosage forms at trial sites, enabling real-time adjustments based on emerging data.

Softgels: Enabling Flexible and Efficient Drug Delivery

Softgel formulations have emerged as an ideal vehicle for on-demand manufacturing. In a recent case study, a pharmaceutical sponsor facing challenges with their molecule turned to Catalent for a solution. The traditional approach would have required manufacturing multiple strengths and using a large amount of active pharmaceutical ingredient (API).

Instead, Catalent implemented an on-demand manufacturing strategy using softgels. This innovative approach allowed for the separate shipment of lipid-based fill formulation and nitrogen-filled softgel capsules to trial sites. Site staff were then trained to fill and seal the capsules at the required doses, providing unprecedented flexibility in dosing.

The results were remarkable:

• API usage was reduced from a projected 250g to just 100g
• Manufacturing timeline was condensed from 36 weeks to 16 weeks
• Overall cost savings of 38% compared to conventional softgel manufacturing

"Suddenly, patients didn't need to swallow up to 75 capsules to achieve a higher dose, and site staff could manufacture a single capsule that contained the dose they needed," Enderlin explains.

Implications for the Future of Drug Development

As pharmaceutical launches continue to grow in complexity, the flexibility offered by on-demand manufacturing and softgel formulations could prove invaluable. This approach not only accelerates timelines but also de-risks entire programs, ensuring smoother transitions from early-phase development to commercial launch.

The success of this strategy demonstrates the potential for innovative manufacturing techniques to address longstanding challenges in drug development. By thinking creatively and collaborating closely with sponsors and regulatory authorities, companies like Catalent are paving the way for faster, more efficient drug development processes that ultimately benefit patients.

As Enderlin concludes, "Our strategy to support customers with their constraints is a keystone in our culture as we help these companies grow their products and create value for patients."