#USA #San Francisco #Persist AI #Microsize #Micromacinazione

Persist AI Partners with Industry Leaders to Innovate Drug Development

In a landmark announcement on June 3, 2026, Persist AI, a company leveraging artificial intelligence and robotics in pharmaceutical research, unveiled a strategic partnership with Microsize and Micromacinazione (Micmac). This collaboration aims to launch the pioneering "Micromill" formulation platform, a transformative step in the early-stage drug development process that allows significantly reduced material use, thus reshaping the approach to formulating drugs.

The Challenge of Traditional Drug Formulation

Historically, determining the best formulation approach for a new drug was a labor-intensive and costly endeavor requiring grams of active pharmaceutical ingredients (APIs) and extensive timeframes. Researchers were often required to consume substantial resources to answer critical questions about whether to micronize a drug or choose alternative methods. With APIs being costly and scarce, errors in later developmental stages can result in excessive financial implications and extended project delays.

Introducing the Micromill Platform

The innovative Micromill platform fundamentally alters this equation, making early-stage formulation decisions more efficient. By integrating the advanced capabilities of Micmac's mini mill, the SSM20, with Persist AI's AI-driven experimentation framework, the collaboration empowers researchers to conduct reliable formulation studies using only milligrams of material.

With this platform, formulation teams can now make vital go/no-go decisions about micronization and bioavailability enhancements right at the beginning of drug development. Doing so not only reduces the cost of decision-making but also mitigates the risks associated with larger-scale production mistakes.

Key Benefits of the Integrated Platform

The Micromill platform offers a comprehensive, integrated formulation workflow that combines various advanced technologies:

• - Risk Mitigation: By requiring only milligram-level inputs, the platform allows researchers to perform particle size reduction campaigns, generating data that can seamlessly scale up through Microsize and Micmac's established manufacturing infrastructure.
• - Rapid Assessment: It offers thorough assessments of thermodynamic and kinetic solubility alongside dissolution profiling. This capability provides preliminary insight into the physicochemical stability of micronized materials under relevant conditions, ensuring better-informed decisions from the outset.
• - Consistency and Documentation: Utilizing proprietary process analytical technologies (PAT), the platform effectively tracks solid-state analyses, particle morphology, and in-process measures—capturing every change made throughout the development process. This ensures reproducibility and transparency, establishing a more deterministic approach compared to traditional, artisanal methods.

Paving the Way for Future Drug Development

The implications of the Micromill platform stretch far beyond mere cost savings. By enabling critical formulation feasibility studies at the pre-investigational new drug (IND) or Phase I clinical trial stages, pharmaceutical companies can:

• - Quickly identify the most effective formulation strategy before committing to an extended clinical development cycle based on potentially unoptimized dosage forms.
• - Conduct de-risking more economically and swiftly, reducing the chance of facing bioavailability challenges when adjustments are still feasible and inexpensive.
• - Sidestep costly downstream reformulations, which can delay drug development processes significantly, especially when scaling up or when clinical data has already been collected.
• - Reduce time to first-in-human studies through the elimination of uncertainties regarding formulations that can otherwise cause project delays.

Expert Insights

TJ Higley, CEO of Microsize, remarked on the collaboration, stating, "The integration of Microsize's advanced micronization capabilities with the data-driven experimentation from Persist AI creates a unique solution that did not previously exist in the market." This partnership combines the strengths of established leaders in particle engineering and AI-driven pharmaceutical formulation, addressing a crucial gap in drug development.

Built-in Scalability

A notable aspect of the Micromill platform is its intrinsic scalability. Data generated from micro-scale experiments can be directly applied to the broader commercial manufacturing operations of Microsize and Micmac, which boast FDA-compliant facilities capable of producing from grams to kilograms across multiple U.S. locations. This seamless transition aims to enhance efficiency and reduce uncertainty during the scaling process, ultimately accelerating drug product time to market.

About the Collaborating Companies

Microsize is a well-respected CDMO (Contract Development and Manufacturing Organization) in the U.S. specializing in micronization technologies with over three decades of experience. They manage FDA-inspected facilities and offer services ranging from micronization to analytical characterization.

Persist AI, on the other hand, optimizes pharmaceutical development timelines through its robotic lab setup and AI expertise, effectively delivering results in weeks instead of months. Their cloud platform enables clients to execute experimental tasks remotely, thus streamlining the drug formulation process.

Micro-Macinazione (Micmac), based in Switzerland, brings over 50 years of expertise in particle engineering and micronization, enhancing the collaborative efforts towards innovative drug development solutions.

In conclusion, the partnership between Persist AI, Microsize, and Micmac is set to redefine the pharmaceutical landscape, fostering more rapid and cost-effective pathways for drug formulation and development.