The abundance of protein drugs on the market shows there is an increasing demand for knowledge within the formulation of biologics, as Professor Pernille Harris, Principal Investigator and Coordinator of the Protein-excipient Interactions and Protein-Protein Interactions in formulation (PIPPI) project explains:
What are the key aims of the PIPPI project and what does it hope to achieve?
One intrinsic area of focus is training PhD students in the biophysical and structural characterisation of proteins in a pharmaceutical setting. They will create a strong intersectoral network between academic and industrial sectors. They will be key opinion leaders of the future. Scientifically, the aims are to create a representative library of structurally diverse proteins, and through a systematic study of their microscopic and macroscopic behaviour in different environments, we will obtain a comprehensive dataset. We will create a database enabling how to best predict protein stability on a minimum number of experiments and guide how to select the best experiments. We will bring biophysical understanding and characterisation tools for formulation of biologics to the next level.
Who will benefit from the research
There will be widespread benefits across academia, industry and the wider public. Global academic research is likely to take a big step forward due to the unprecedented amount of coherent biophysical data that will be made available by the consortium. For industry, it will deliver the ability to recognise the potential values of biophysical techniques normally used only in academia. They will also gain an understanding of which of the currently used high throughput techniques add more value to the drug development process. For society, it will improve healthcare due to more robust formulation development processes, and at the same time, improve the costeffectiveness of biologics. It will also allow the European Union (EU) to build on its strong pharmaceutical industry and take the lead in future drug development. Having the edge in knowledge on protein formulation will lower the risk of failure and increase the likelihood of better and more convenient dosage forms (for example, suitable for home treatment instead of hospitalisation). Overall, industry and academia in the EU will benefit from a large pool of highly skilled researchers and research groups.
Why do so few universities in Europe have formulation of biologics as a subject?
Except for a few examples, the use of biologics is a relatively new field within the medicinal industry. Traditionally, the big pharma industry is focused on small molecules, and teaching in academia, as well as public funding, are often driven by industrial opportunities. In society, it is recognised that protein drugs are more expensive and difficult to develop and less convenient for the patient, whereas it is not acknowledged that at the same time, biologics are often safer, with fewer sideeffects and are much more precise in their mechanism of action and efficacious in treatment of diseases compared to small molecule-based drugs.