(English transcription)

Faster Development for an Increasingly Complex Molecule Landscape

The pharmaceutical industry is experiencing an unprecedented surge in molecular innovation. Advances in medicinal chemistry, computational drug discovery, and targeted therapeutic approaches have expanded the number of promising candidates entering development pipelines. However, this progress has also created a growing challenge: an increasing proportion of these molecules exhibit poor aqueous solubility, often limiting their oral bioavailability and creating significant barriers to successful product development. Amorphous solid dispersions (ASDs) have emerged as one of the most successful solutions to this challenge, enabling significant improvements in drug exposure and supporting the oral delivery of compounds that would otherwise be difficult to develop and likely be discarded in the drug discovery phase. 
 

Amorphous Solid Dispersion (ASD)

However, the challenge facing the industry today is no longer simply finding an ASD formulation capable of improving solubility. Rather, it is identifying the optimal formulation quickly enough to support increasingly aggressive development timelines to reach clinical phases. In fact, early entry into First-in-Human studies can be a critical value driver, shaping internal and external investment decisions, enabling partnership opportunities, and strengthening competitive positioning. Beyond therapeutic potential alone, these factors can determine the overall success of a development program and, ultimately, accelerate patient access to innovative medicines.
Traditional development approaches, however, often rely on sequential experimentation and iterative optimization cycles. Multiple formulation concepts are tested, refined, and retested before a lead candidate emerges. While scientifically robust, this process can consume valuable active ingredient, extend timelines, and introduce uncertainty regarding future manufacturability and scale-up. Furthermore, formulation development and clinical supply manufacturing are frequently performed by different organizations or across multiple sites, creating discontinuities in development. Consequently, critical formulation and process risks are often identified only after significant investments have been made, resulting in delays, increased costs, and additional development complexity.

As a result, the industry is increasingly shifting toward development models that prioritize rapid learning, data-driven decision making, and early identification of integrated and scalable solutions. The focus is moving from simply developing formulations to accelerating the pathway from candidate selection to clinical evaluation while maintaining confidence in future commercial success. 

Accelerating Formulation Selection and Clinical Supply with ASD HIPROS

Towards tackling this market need, Hovione has introduced ASD-HIPROS in its service offering, an integrated platform designed to dramatically shorten the formulation development cycle for spray dried amorphous solid dispersions. The platform integrates predictive computational formulation screening, automated spray-drying prototyping under directly scalable process conditions and rapid analytical assessment, enabling informed and de-risked formulation selection while providing a clear path to clinical supply in weeks rather than months.

Hovione spray drying facility

The philosophy behind ASD-HIPROS is fundamentally different from traditional trial-and-error development. A computational screening platform are used to evaluate formulation options before laboratory work begins, helping to prioritize the most promising combinations of active pharmaceutical ingredient (API), polymers, and surfactants towards optimal physical stability. The platform leverages molecular structure-based predictive models to assess solubility, polymer miscibility, glass transition temperature, and drying kinetics, enabling a comprehensive evaluation of phase separation risk in amorphous solid dispersions and avoid undesirable concepts.

Once promising candidates have been identified, automated prototyping capabilities, including solution preparation, spray drying and secondary drying, allow numerous concepts to be produced and evaluated in less than a week and with only a few grams of API. All concepts are then compared for physical stability and dissolution indicators and reanalysed after a one-month stress stability to support the final formulation ranking. Small samples of the winning concepts can be immediately produced to supply PK studies for the final formulation selection within a timeframe of two months. 

Overall, instead of spending months generating and comparing alternatives, development teams can rapidly build a robust understanding of formulation performance and establish clear development priorities. The result is not simply a faster screening process but a more informed one, enabling decisions to be made on the basis of a broader and richer dataset. 

An Integrated CDMO Approach to Accelerating Clinical Supply and Reducing Development Risk

ASD-HIPROS was designed not simply as a formulation screening platform, but as the starting point of a broader development strategy aimed at enabling a rapid and de-risked journey to clinical supply. While identifying high-performing ASD formulations is essential, the true objective is to ensure that these formulations can progress efficiently into clinical supply without requiring significant redesign or redevelopment. From the earliest stages, formulation selection is therefore guided not only by performance, but also by scalability, manufacturability, and long-term development potential. 

Once lead formulations have been identified through ASD HIPROS, they enter a structured de-risking pathway designed to generate the knowledge required for successful clinical development. Development activities focus on establishing scale-independent process understanding, generating materials representative of future manufacturing conditions, and evaluating formulation robustness under process-relevant and stability-related stresses. Importantly, these activities extend beyond the spray-dried intermediate itself and encompass downstream drug product development, including both conventional batch tableting or more cutting edge continuous tableting. By addressing critical development questions at laboratory scale, substantial amounts of future uncertainty can be eliminated before scale-up activities begin. 

This integrated approach fundamentally changes the development model. Instead of relying on extensive experimentation and optimization at pilot or GMP scale, much of the critical process and product understanding is generated early, when experimentation is faster, less costly, and less API-intensive. As a result, activities at manufacturing scale can be minimized and, in many cases, avoided altogether, enabling faster but de-risked clinical supply delivery. The value of this approach is measured not only in months saved during development, but also in the reduction of resource requirements across both client and CDMO teams as programs progress toward clinical execution.

Hovione's integrated CDMO capabilities further reinforce this strategy. The company combines expertise in spray drying and tableting across multiple scales and manufacturing sites, spanning early clinical supply through to commercial production, within a single, integrated development continuum. This is particularly important because many development challenges emerge at the interfaces between formulation, process, and manufacturing activities. By integrating these disciplines from the beginning, potential risks can be identified and addressed earlier, preventing delays and reducing the likelihood of costly redevelopment cycles later in the program.

Moreover, even when unexpected challenges arise, whether during laboratory development, clinical supply, or commercial manufacturing, the ability to rapidly troubleshoot within structured, regulatory-compliant procedures becomes a significant competitive advantage. As a global leader in spray drying, with industry-leading experience and capacity, Hovione draws on more than 250 ASD development programs and over 30 commercial spray-dried products. This extensive technical, operational and quality expertise enables faster problem-solving, reduces development risks and helps keep projects on schedule.

Overall, the future of oral drug development will increasingly depend on the industry's ability to combine speed, scientific rigor, and manufacturing readiness within a single integrated strategy. The combination of ASD-HIPROS rapid prototyping and Hovione's integrated CDMO platform follows this philosophy, creating a development model focused on a single objective: reducing uncertainty while accelerating execution. By linking formulation selection directly to scalable manufacturing pathways, Hovione aims to help innovators accelerate the journey to clinical studies while strengthening confidence in long-term development success.

However, ASD-HIPROS is only one component of a broader integrated offering. Hovione's capabilities span the entire development continuum, from rapid formulation screening and particle engineering through drug product development, clinical manufacturing, and commercial supply. Hovione's latest advances in these streamlined development approaches will be presented at the 8th Small Molecule Drug Innovation Summit in Nanjing, China, on August 13th and 14th.
 

Read the full article in Chinese here