Nanomedicines, the future that could be
New technologies are getting smaller and smaller. We started out with micron-level inventions when we produced the first computers. Now, semiconductors and other technological advances are letting us go even smaller. We’ve now gotten to the point where we’re developing medicines one million times smaller than the millimeter scale.
We call that the nanoscale.
The life sciences industry has already produced a handful of nanomaterials approved by the FDA for human use. And many more are on the way. Yet struggles still abound because of potential side effects, the complexity of combining ingredient formulations, and the difficulty of testing formulations at high-throughput rates.
For a startup company developing nanomedicines, the research required may feel like an insurmountable obstacle.
Nanoworx recognized this obstacle and formed just last year to help clients develop their nanomedicines. From their facilities at the University of Eindhoven, Nanoworx is establishing the infrastructure and expertise to solve the biggest problems in developing nanomedicines for clinical trials.
And in this iteration of our Innovation AveNEW series, we’ll hear from Nanoworx’s Co-founder and COO, Anna-Maria Makri-Pistikou. If you want to hear about nanomedicines and the ways that Nanoworx helps companies across the EU make nanomedicines a reality, continue reading below!
The Interview
What are nanomedicines, and how do we develop them?
PN: Nanoworx specializes in nanomedicines, as the nano in your company name suggests. What is nanomedicine, and how have patients already seen nanomedicine at work?
AMP: Nano refers to anything between 1 to 100 nanometers (nm) long, known as the nanoscale. Nanomedicine, then, uses any material and device to diagnose, prevent, and treat diseases at nanoscale. At this scale, we can tailor precise interactions with biological systems that improve therapeutic outcomes and reduce side effects.
We’ve already seen nanomedicine enter public discourse during the COVID-19 pandemic. mRNA vaccines were being developed and administered at breakneck pace. Although the field seems new to the public eye, nanomedicine has deep roots. The first FDA-approved nanomedicine, Doxil, was approved 30 years ago for cancer treatment.
Since then, the focus has now shifted. Now, we’re seeing broader applications for nanomedicine, including immunoregulation and other RNA-based therapies such as liposomes protecting the mRNA from being degraded. Altogether, the potential for nanomedicine to transform clinical care remains immense, and we could see even more adoption of nanomedicine in the coming years.
PN: How are nanomedicines currently designed, and how could we accelerate the process and meet the growing need for nanomedicines?
AMP: Traditionally, a nanomedicine concept originating from academia or a biotech startup is directly taken to Chemistry, Manufacturing, & Controls (CMC), Scaling, and Good Manufacturing Procedures (GMP) manufacturing so it can be used in the clinic and eventually enter the market. This approach produces safe nanomedicines but doesn’t leave much room for refining the formulation. Specifically, by adjusting the ratios of their components, you can increase performance by orders of magnitude.
PN: It sounds like we need to update our approach for developing nanomedicines.
AMP: Indeed. If we want to see nanomedicines more widely adopted, we must meet several key requirements. First, we need to secure their safety and efficacy through rigorous preclinical and clinical studies that address concerns about toxicity, biodistribution, and therapeutic performance. Second, nanomedicines must also ensure regulatory compliance. That involves adhering to Good Laboratory Practices (GLP), GMP, and detailed characterization of nanoparticles (e.g., size, chemistry) to secure market authorization from regulatory agencies. Lastly, we need to develop manufacturing processes that produce consistent, high-quality nanomaterials at scale.
Given these requirements, I believe we need a contemporary approach to developing nanomedicines. Here, we produce compound libraries and screen diverse formulations to test for several variables. This process is especially useful in nanomedicine because we don’t have a rational way to design drugs a priori. The way to do it is very similar to traditional small molecule drug development, which is where building libraries comes in. Larger pharma companies can build library screening facilities in house, but smaller players can’t.
What are CROs, and how does Nanoworx advance nanomedicine research?
PN: So, is this where you come in with Nanoworx?
AMP: Precisely. We’re an independent contract research organization (CRO) that fills this void by connecting state-of-the-art technology with leading expertise at the Eindhoven University of Technology (TU/e) campus. After founding Nanoworx last year, we’ve already partnered with Trained Therapeutix Discovery (TTxD) to support their development programs.
PN: It’s amazing that you’ve already worked with a partner! I know that you expedite and refine development trajectories with a design, production, and library screening service. Tell us more about these services and how they help companies develop nanomedicines for clinical care.
AMP: So, we offer four services that guide partners from initial concept to clinical-ready nanomedicines:
- Nanomedicine Design & Prototyping: First, our team’s expertise covers all facets of nanomedicine development. That expertise helps partners design novel nanoformulations tailored to specific diseases or targets. When clients work with us, we create prototypes and, when needed, outline the Chemistry, Manufacturing, and Controls (CMC) trajectory to ensure a smooth development path for them.
- Library Production: We also produce nanomedicine libraries in a high-throughput manner, using validated equipment. This step can follow the design phase, but it is also accessible independently for clients further along the development pipeline. Either way, the resulting libraries can be shipped directly to partners for further evaluation. Along with the libraries, our experienced scientists and engineers also provide reporting and analysis for the libraries, tailored to our clients’ needs.
- Lead Production: After a client identifies leads from our libraries, we can produce them at scale, ranging from intermediate (~10 mL) to large-scale (liters) batches. Outcomes from our library productions can seamlessly transition to this service, ensuring consistency and efficiency in scaling-up promising candidates for further development.
- Screening: Our high-throughput in vitro screening service — currently in development and available in Q3 2025 — evaluates nanomedicines for toxicity, cell viability, uptake, and transfection efficiency. This step optimizes leads by providing critical data to refine formulations before advancing to preclinical or clinical stages.
Additionally, we collaborate with industry leaders to facilitate GMP production, ensuring a smooth transition to clinical-grade materials.
Altogether, this comprehensive approach is unique, as underscored by the market analysis Nanoworx conducted through an independent consultancy firm early 2024. By offering these services, Nanoworx empowers partners to overcome development hurdles, accelerate timelines, and deliver innovative nanomedicines to patients.
PN: You offer several services all at once, but there are also many CROs that conduct preclinical research. What makes a CRO successful?
AMP: Picking the right CRO can be the difference between success and failure for many biotech startups. A successful CRO must demonstrate the following traits to best help companies develop nanomedicines:
- Effective communication: CROs must communicate clearly to align on project goals.
- Professionalism: CROs must also respond to concerns with competence and maintain ethical conduct to deliver research outputs and meet deadlines.
- Unmatched expertise: CROs don’t just need to know about the science behind nanomedicines. You also need to know how to deliver those messages to your clients and navigate the complex intellectual property (IP) landscape.
- Advanced infrastructure: CROs must also have the equipment and the organizational skills to scale up development and production lines. These same workflows must also offer regulatory compliance support to meet standards set by agencies worldwide, such as the FDA or EMA.
PN: How does Nanoworx supply all four, and how do you distinguish yourselves from other CROs?
AMP: Many CROs solely focus on conducting research and meeting experimental and reporting goals. We at Nanoworx are not like that. We want to set up our clients for long-term success as they develop nanomedicines for patients. To start, we coach and train our clients throughout our partnership. Our clients will become familiar with our advanced equipment and extract meaning from the data we generate from their nanomedicine candidates. They will also keep any intellectual property (IP) that’s generated from their research activities. This ensures clarity, transparency, and fairness as we wok with our clients.
We at Nanoworx also differentiate ourselves by specializing exclusively in self-assembled nanomedicine systems. Just check out some of the validated platforms we’ve developed: Lipid Nanoparticles (LNPs) and nanobiologics, along with ongoing proof-of-concept work in lipid-based micelles, apolipoprotein nanoparticle (aNP) technology, nano/microemulsions, and liposomes. By focusing on nanomedicine, we can also explore other novel systems, such as polyplexes, polymeric micelles, polymeric nanoparticles, and polymersomes. Over the next one to two years, we will refine our focus to offer the most reliable and impactful platforms for developing nanomedicine, all from our facility, embedded within the university ecosystem.
How does automation factor into nanomedicine research and development?
PN: You highlighting the importance of advanced infrastructure ties well with what SLAS is doing to promote automation in the life sciences. How have you integrated automation into your operations?
AMP: We’re already integrating automation into our operations at Nanoworx. We have several machines and tools that automate library production, prototype nanomedicine candidates, and design nanomedicines for further testing. Combined, our automated systems form an infrastructure that lets us generate and test diverse nanomedicine formulations. Our automated workflows also deliver data and diverse compositions to our clients at speeds orders of magnitude faster than traditional lab methods. As a result, biotech companies partnering with Nanoworx will benefit from significantly enhanced efficiency. With us, they will see their research accelerated and development timelines pushed forward for innovative nanomedicine solutions.
PN: Given this interview, your selection as an Innovation AveNEW company for SLAS Europe 2025 is well-deserved. Congratulations! How does receiving this honour help you build towards your ambitions to expand to the rest of Europe and beyond?
AMP: Nanoworx aspires to be a leader in nanomedicine development, starting in the EU and then expanding globally. Being an Innovation AveNEW company gives us a chance to boost our visibility and credibility in nanomedicine and automation sectors. Our attendance at SLAS Europe 2025 also came with several benefits. It helps us connect with global life sciences researchers, decision-makers, and partners. We also received a complimentary kiosk space, travel support, and access to SLAS Ignite workshops. We also gained opportunities to publish in SLAS’s journals. Altogether, each of these features will strengthen our brand authority and propel Nanoworx towards scaling our services across the Netherlands, the EU, and beyond to drive advancements in nanomedicine worldwide.
