Expert perspective: How microdosing in clinical trials is accelerating drug development
Microdosing technology has become a powerful tool for clinical trials, offering precision, flexibility, and scalability that helps drug developers move quicker through the pipeline. Microdosing, often part of Phase 0 or exploratory clinical trials, involves administering very low, sub-therapeutic doses of a drug to gather preliminary data on its pharmacokinetics and pharmacodynamics. This allows researchers to assess the safety and biological activity of a drug early in the development process in a cost-effective manner, without exposing participants to significant risks. Thermo Fisher Scientific is at the forefront of this evolution, and we spoke with two experts—Jutta Wagner and Christian Rose—about how Thermo Fisher’s advanced microdosing capabilities are transforming the path from early-phase trials to commercialization.
Christian Rose is the Manager of Process Engineering at Thermo Fisher Scientific in Basel, Switzerland. He participates in customer consultations and provides diverse engineering support in all aspects of clinical studies. With over 10 years of experience in the pharmaceutical industry, he is also a qualified technical project manager and has a background in process engineering and biotechnology.
Jutta Wagner is the Global Program Director at Thermo Fisher Scientific in Basel, Switzerland. She specializes in clinical manufacturing, managing the blinding of comparators, analytical development, microdosing of active pharmaceutical ingredients, and inhalation projects. Jutta oversees customer consultations and provides technological and CMC support. With over 20 years of experience in the pharmaceutical industry, she is also a qualified clinical research project manager and has a background in national economics and business administration.
Q: What is microdosing, and why is it becoming more important in clinical development?
Jutta Wagner: Microdosing in this context refers to the precise filling of capsules with very small amounts of active pharmaceutical ingredient (API), often between 1 and 200 mg. It allows drug developers to streamline the formulation process and adapt quickly to different trial needs.
At Thermo Fisher, we’ve been offering microdosing for many years, primarily for early-phase clinical development. Recently, we’ve noticed a clear trend that our customers are looking to use microdosing for later stage clinical phases as well. That’s why we’ve invested in high-speed, scalable microdosing solutions. It helps biotech and biopharma innovators bring their products to market faster—without having to change formulations midway. Ultimately, this gets medications to patients sooner.
Q: How does Thermo Fisher ensure precision and control with microdosing?
Christian Rose: Our microdosing technology leverages advanced mass verification to ensure 100% net weight control for each capsule filled. Due to the precision of this technology, there is an increase in safety and compliance, which allows our clients to move through clinical phases more efficiently. In turn, they can commercialize sooner—maximizing the patent window and accelerating time to peak sales.
Q: What types of formulations and therapeutic areas does this support?
Jutta Wagner: This technology supports a wide range of APIs, including potent compounds and powders with poor flow characteristics, like spray-dried powders. It’s flexible across dose levels—from 1 mg up to around 200 mg—with consistent accuracy. This enables a drug-in-capsule approach that works from Phase I through to Phase III, and even commercialization. This flexibility allows developers to explore both pediatric and adult dosing without reformulating—saving time and cost.
Q: How does microdosing impact the overall drug development timeline?
Q: What makes Thermo Fisher a strong partner for microdosing trials?
Jutta Wagner: We provide an integrated solution—from research and manufacturing to clinical supply execution. Our robust quality systems, packaging, labeling, storage, and distribution services are all designed to mitigate risk and ensure compliance. Clients can scale their programs with confidence, knowing we’re supporting every step.
Thermo Fisher’s advanced microdosing platform can bridge the gap between early and late clinical phases to support faster timelines and consistent quality with reduced costs. Whether you’re developing a complex molecule or looking to streamline your scale-up, microdosing could be the key to accelerating your drug development pipeline.
To learn more about how Thermo Fisher’s microdosing capabilities can accelerate your development goals, contact your Thermo Fisher representative.
