Photo: Novozymes

Knowledge of proteins to guide pharmaceutical industry

Wednesday 23 Sep 15


The project

 'PIPPI' is short for Protein-excipient Interactions and Protein-Protein Interactions in formulation.

List of partners

  • DTU (Technical University of Denmark)
  • University of Manchester
  • Ludwig-Maximilian University of Munich
  • Lund University
  • Novozymes A/S
  • Wyatt Technology Europe GmbH
  • Medlmmune Ltd
  • University of Copenhagen
  • MAXIV Laboratory
  • Nano Temper Technologies GmbH

Knowledge of the properties of proteins right down to atomic level is essential for making it easier and faster for the pharmaceutical industry to manufacture protein-based drugs in liquid form. Over the next four years, a joint European project, PIPPI, with DTU as the overall coordinator, is to develop a public database with cutting-edge knowledge about the properties of proteins in pharmaceutical formulations.

The average age of Europe's population is rising, which translates into financial challenges for the healthcare sector. Greater focus is also being devoted to manufacturing safe and risk-free drugs, while the requirements for evaluating new drugs and their possible side effects are becoming stricter. All of this has moved the pharmaceutical industry towards protein-based drugs, which have high specificity and relatively few side effects. But there is very little knowledge of the way these proteins behave in the solutions in which they are sold.

Together with a large number of partners from both the pharmaceutical industry, European universities, and other stakeholders, DTU has received DKK 30 million from Horizon 2020. This is for the development of a data base over a four-year period, which is to ensure more efficient development of the very extensive and protracted screening process that protein-based drugs, e.g. next generation insulins and growth hormones, undergo before being put on the market.

"Drugs as we know them from the pharmacy typically consist of an active substance such as paracetamol in painkillers. In addition to the active substance, there are other substances in the finished tablet, for example, excipients facilitating that the tablet is dissolved in the right way and stabilizes the active substances. Similarly, excipients are added to protein solutions to increase the stability of proteins.Today, the pharmaceutical industry carries out very extensive screening of all these excipients to test their performance with the active substance. It is this screening process that we hope to be able to streamline with this project," explains Pernille Harris, Associate Professor at DTU Chemistry, who is the overall coordinator for the entire project.

Few universities in Europe have formulation of biologics as a scientific subject. Consequently, the pharmaceutical industry is required to train hired scientists.

“We are proud to be part of a consortium comprising leading researchers in protein and pharmaceutical science in Europe. We have high expectations that PIPPI will help boosting the knowledge in the field. Furthermore, we hope that PIPPI will result in increased focus to the field, so that Europe can catch up with USA and Asia,” says Jens Bukrinski, senior scientist, Novozymes A/S.

15 new PhD positions from 2016
While the substance paracetamol is a small organic molecule, which will keep for a long time in a tablet, protein-based drugs are more unstable, the challenge in respect of these drugs is, for example, to eliminate the risk of the proteins, in their aqueous solution, precipitating into the solution.

"Today, the pharmaceutical industry manufactures the drugs by testing and screening until they obtain a solution that keeps the active substance suspended in the liquid. The idea of the project is to establish as many as 15 PhD positions with the various partners in the project at the same time. Initially, a comprehensive protein library will be established, representing the different properties that proteins can have, for example in terms of size, whether they are positively or negatively charged, hydrophobic or flexible. Subsequently, their abilities to interact with various substances will be characterized and everything will be gathered in a database," explains Pernille Harris.

Ultimately, knowledge right down to the atomic level about the different types of proteins may make it easier to predict the behaviour of a similar protein targeted for use by the pharmaceutical industry. The aim is for the protein to be stable in the solution, and although this result can be achieved today, getting there may be a long and hard process.

"And at the end of the day, you may still not be completely certain why it actually works," explains Pernille Harris.

The first PhD positions will be advertised in February 2016. 

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