Formula One ApS

At Formula One, we formulate injectable peptides and proteins before handover to your favorite drug product GMP manufacturer. We even assist with the technology transfer if needed. With minimal overhead, we’re able to provide more value at a lower cost than larger outsourcing partners. Yet, we’re committed to innovation and customers benefit from our up-to-date domain knowledge. Connect with us if you are curious to learn more! #drugdevelopment #drugdiscovery #pharma

Formula One is our name—formulation development is our game. We develop injectable peptides and proteins from our lab in Denmark, preparing your molecule for human trials and beyond ✨ . Since we’re a small and agile organization, our customers enjoy the flexibility we provide to uniquely tailor our solutions to the needs of our customers 🤝 . Follow us for more news and get in touch! #drugdevelopment #drugdiscovery #pharma

Last week Faramarz Moshfegh gave an insightful talk about what we are doing at Formula One to enhance better decision making in early phase formulation development. A big thank you to the organizers of the 'New Updates in Drug Formulation and Bioavailability' event for hosting such an excellent gathering, filled with inspiring talks on the latest innovations in drug formulation.

We have what it takes to develop your next injectable peptide and protein formulation. 🤝 If your lead molecule is moving towards non-clinical safety studies or first in human trials then get in touch with us and learn more about how we can support your clinical development journey. 🚀

Dynamic light scattering (DLS) is an effective technique for investigating the hydrodynamic particle size of peptides or proteins under various solution conditions. 💡 It offers insights into the self-association behavior of molecules in different pH and buffer environments. This understanding is crucial as molecular self-assembly can sometimes stabilize formulations 👍 but it can also lead to aggregation and precipitation 👎 . Understanding your molecule early on can significantly improve the likelihood of designing a stable formulation for human use. Get in touch with us if you want to learn more about our capabilities. 📧 ☎ #biotech #formulationdevelopment #peptide #protein 

Physical stability is a tricky phenomenon when working with peptide and protein formulations. 🔬 It is close to impossible to predict in advance how your molecule will behave under different stress conditions. ❓ Will it unfold and become biologically inactive? Will it form particles with potential safety issues? Will the viscosity increase and complicate injectability? To mitigate the physical stability risks, we use a range of experimental tools to understand the nature of your molecule and how to stabilize against the inherent stability issues. Get in touch with us if you want to reduce the risk of product failure associated with your clinical peptide or protein. 📧 ☎

At Formula One, we understand the inherent challenges of transitioning from molecule to a clinically feasible product. That's why we're here — to help make the process as smooth as possible. 🚀 Our dedicated team of scientists are ready to support your next drug development project. 👨🔬 👩🔬 We have a passion for the art and driven by designing high quality products to the benefit of the patients. Reach out to us if you want to learn more 📱 📧

Having Formula One as your early phase development partner guarantees a smooth transfer of the developed drug product. Once you choose collaboration with us you will gain access to a range of benefits. 👨🔬 Access to a scientific team in formulation development and customized solutions for transferring developed products to the first GMP manufacturing site. 🏭 Selection of the best suited GMP manufacturing partner since we have solid experience with CMO collaborations. 🌊 Implementation of the technology at the GMP site ensured by the same people who developed the product. Our commitment goes beyond laboratory scale development. We ensure that our client’s ambitions translate into reality to the benefit of the patients. Don’t hesitate to reach out to us with your enquiry or ideas for collaboration.

Analytical characterization is the heart of any biosimilar development program. In this case we used nDSF and DLS to compare the biophysical profile of a biosimilar formulation to the originator product. Both drug product materials tested were at end of shelf life at the time of analysis. The data showed comparable melting temperatures but significantly higher polydispersity index for the originator. Next steps in product development would be to understand if the observed difference in hydrodynamic particle size distributions affect product safety and efficacy. Alternatively, the biosimilar formulation can be modified to resemble the originator colloidal particle size and distribution.     

Ready to elevate your injectable peptide or protein formulation? 🔬✨ Gain a strategic advantage with our cutting-edge pre-CMC package. By leveraging decades of formulation development experience and modern experimental design, we have combined the power of Design of Experiments (DoE) with insightful statistical analysis to enhance early phase decision-making. 🚀 Stay ahead of the competition with our budget-friendly pre-CMC work package, delivering results in record time.