In the last five years, amofor has rapidly transformed from a German academic start-up to a highly innovative force revolutionizing drug formulation with physics-based in silico modeling. On this occasion, the two founders, Christian Lübbert and Gabriele Sadowski, shed some light on the origins and driving forces behind amofor.
Who is behind this company, and what inspired you to start it?
Christian and Gabriele are the co-founders and managing directors of amofor. In 2019, we founded the company as a spinoff from TU Dortmund University. We founded the company because we had a strong passion for science and saw an opportunity to bridge the gap between academic research and highly needed industry applications. We’re a small but dedicated team driven by the desire to push boundaries and find scientific solutions for complex problems in drug formulation.
How would you describe the values and qualities that define amofor?
Christian: We are very passionate about science. For example, we’re constantly publishing and engaging in peer-review activities. Personally, I’ve always been fascinated by how scientific principles can solve real-world problems. This fascination led me to leave academia and co-found amofor, where we could directly apply our knowledge to make a tangible impact on drug formulation.
Our approach is also about connecting the industrial world with science. We strive to explain mechanistic phenomena that others can’t, which drives us every day. Therefore, we are also deeply grateful for the trust drug formulators place in us to tackle complicated problems involving complex small molecules exhibiting unusual behavior.
With your predict-first strategy of physical modeling, amofor initiated a significant paradigm shift in drug formulation. How did you achieve this, and what has evolved over the last five years?
Gabriele: Coming from an academic background, we were curious to know how pharmaceutical formulators work. We started by focusing on calculating phase diagrams through thermodynamic modeling. Phase diagrams are crucial because they illustrate how different components in a formulation interact under various conditions, like temperature and humidity.
However, we realized that simply providing phase diagrams wasn’t enough for practical application. Over the last five years, we’ve evolved to offer comprehensive packages that help clients integrate thermodynamic knowledge into their formulation development. We can now predict critical attributes such as shelf life, the best manufacturing process, potential drug load, bioavailability, and optimal excipient selection.
This evolution has been one of our key milestones. Our clients value that we go beyond just calculations but provide reliable insights. They trust the clear outcomes of our computations, knowing the results are validated and help them to understand lab observations they couldn’t explain before.
Can you share some numbers or examples highlighting amofor’s growth in data points and the impact on clients?
Gabriele: Initially, we had several hundreds of data points from our lab experiences – a substantial amount at that time. But now, utilizing advanced modeling techniques like PC-SAFT (Perturbed Chain Statistical Associating Fluid Theory), we’ve already worked with around 140 real-life complex molecules in development! While we can’t add these to our public SOLCALC software database due to confidentiality, we’ve significantly expanded our knowledge base.
Christian: For example, our database, especially in the field of excipients, has grown by a factor of five. We continuously receive client feedback, collect physical parameters, and add new molecules. We now include most polymers relevant for Amorphous Solid Dispersion (ASD) development, even distinguishing between different excipient grades and suppliers. This level of detail was unheard of when we started.
This expanded knowledge base has enabled our clients to accelerate their formulation processes, reduce development costs, and bring effective therapies to market more efficiently.
Your in silico approach offers more than just predictions – it provides causalities. Can you elaborate on explaining the “why” behind your recommendations?
Christian: Of course. We can justify our decisions based on intermolecular interactions and the specific properties of the API (Active Pharmaceutical Ingredient) molecule. For example:
– For fast-crystallizing APIs, we focus on physical stability to ensure shelf life. We emphasize the selection of excipients and conditions that enhance stability to ensure that the product remains stable over time.
– For APIs that don’t crystallize in their pure state, physical stability is less of a concern. In these cases, we focus on release behavior to optimize how the drug is delivered in the body.
We support our recommendations with quantitative data, comparing the strength of intermolecular interactions between different excipients. This mechanistic understanding allows us to rank options and explain the rationale behind each choice effectively.
In contrast, typical screenings at CDMOs often rely on standard experimental setups. They test different combinations, observe the results, and simply select the one that works without understanding the underlying reasons. It’s a trial-and-error approach – they might say, “This one worked; let’s go with it,” but they can’t explain why it worked or predict how changes might affect the outcome.
Gabriele: Our physics-based modeling provides a scientific basis for our recommendations. By understanding the fundamental interactions at play, we can explain why a particular formulation works while another does not. This helps not only to make sound decisions but also to predict how environmental changes will affect the product quality. Physics-based modeling is the most scientific approach available.
Shifting focus to the obstacles you’ve faced, what challenges have you encountered over the last five years?
Gabriele: Transitioning from an academic mindset to a customer-centric approach was a significant shift. We had to become more flexible and accept that not everything goes as planned. One key lesson has been the importance of listening carefully to customers. It’s not enough to say, “We have a model like PC-SAFT, and it will work.” We need and want to understand their specific problems and provide tailored advice. Sometimes, that means acknowledging when we can’t help with a particular issue and guiding them to someone who can. Being adaptable and responsive to client needs has been crucial.
You’ve built a strong community and client base around amofor. How did you achieve that?
Christian: We’ve focused on connecting with open-minded people who seek scientific explanations and are receptive to new approaches. Over the past five years, we’ve identified the key scientists within companies who can benefit the most from our expertise.
Building these relationships isn’t achieved through broad advertising or attending a single conference. It takes many forms, including specialized workshops, participating in industry symposiums, and offering one-on-one consultations. By understanding their specific challenges and demonstrating how we can add value, we’ve built strong, collaborative relationships.
I’m grateful to our customers for their willingness to dive deep into scientific understanding. Their openness allows us to apply our mechanistic models effectively.
Looking ahead, what excites you about the future of amofor?
Christian: Reflecting on our journey, seeing how our academic research has evolved into practical solutions that genuinely impact drug development is really rewarding. As we look to the future, we’re eager to develop our physics-based modeling further to tackle even more complex pharmaceutical challenges and strengthen collaborations with our clients. More details to come at the beginning of 2025!
If you’re interested in learning how amofor can accelerate your drug formulation projects, please don’t hesitate to contact Christian or Gabriele for a personalized consultation!