Innovative Manufacturing Approaches Accelerate Clinical Timelines in Pharmaceutical Industry

On-Demand Manufacturing with Softgels Cuts Costs and Time in Early Clinical Development

In a rapidly evolving pharmaceutical landscape, drug developers are facing increasing pressure to accelerate timelines and optimize resource allocation. A recent breakthrough in manufacturing strategy promises to address these challenges, particularly in early-stage clinical trials.

Streamlining Phase I Studies with Flexible Formulations

Traditional approaches to Phase I clinical studies often involve creating multiple formulations for different dosage levels, a process that can be both time-consuming and resource-intensive. This inflexibility can lead to delays in drug development and increased costs.

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."

On-Demand Manufacturing: A Game-Changing Approach

To address these challenges, an innovative on-demand manufacturing approach using softgel technology has been introduced. This method combines formulation development, clinical manufacturing, regulatory support, and clinical testing into a single adaptive program.

Unlike traditional methods that require manufacturing therapeutics at various doses in advance, on-demand manufacturing shifts the production of dosage forms to trial sites. This allows for real-time adjustments based on emerging data, enabling flexible and rapid dose escalation.

The approach has shown remarkable results in a recent case study. A sponsor facing complex issues with their molecule turned to Catalent for a solution. By implementing on-demand manufacturing with softgels, the sponsor achieved significant improvements:

• 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

Softgels: Enabling Flexible Formulations

The success of this strategy hinges on the use of softgel formulations, which are particularly well-suited for on-demand manufacturing. Instead of shipping pre-dosed capsules, the lipid-based fill formulation and nitrogen-filled softgel capsules are sent to sites separately. Trained site staff can then fill and seal the capsules at the required doses.

This approach eliminates the need for patients to consume large numbers of capsules to achieve higher doses, with Enderlin noting, "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."

As pharmaceutical launches continue to grow in complexity, flexible formulations like softgels are poised to play a crucial role in helping developers overcome logistical challenges, manage costs, and condense timelines during early clinical development.