Making pharmaceutical drugs and vaccines is a complex process. Biopharmaceuticals, those medicines that are produced in or extracted from biological sources, are increasingly important within the pharmaceutical industry, and rely on quality animal cell cultures. But this requires heavy, expensive equipment, which needs to be operated by expert staff, to consistently monitor and operate the cell cultures.
“The instruments [currently in use] are expensive to run, they are delicate machines, they need a lot of service,” says Prof. Veronique Chotteau, Associate Professor at the KTH - Kungl. Tekniska Högskolan (Royal Institute of Technology) in Sweden and coordinator of the Innovative Medicines Initiative (IMI) project iConsensus.
The idea behind iConsensus is that a series of miniaturised tools can be developed that can be integrated into one single platform which will monitor and manipulate biological processes, making drug development faster, cheaper and more efficient.
The driving force behind the innovative technology needed to produce these tools is thanks to small and medium-sized enterprises (SMEs). Combining the agility and specialist knowledge of SMEs with the know-how of academic experts who create new approaches enables iConsensus to delve deep into these niche problems. Added to that, the SMEs can gain instant feedback from pharmaceutical companies – their future clients – as part of the IMI project.
“You have smaller companies who have the technology and the expertise to develop these analytical tools. Then we [the pharmaceutical industry] do some testing and then the SME knows that this is working or this isn’t working. And it’s this combination that is very strong,” says Dr Luc Kupers of Sanofi, who is involved in the project.
The pharmaceutical companies want their drug production process to be faster, more efficient and more accurate, but their in-house expertise is focused on producing medicines rather than producing biological tools.
“From an industry point of view, we are interested in using this technology but we are not developing any technology ourselves,” says Dr Kupers.
The iConsensus project is a win-win scenario for both the industry and SMEs, because the industry gets an improved technology to help them produce drugs faster and more efficiently, while the SME gets a future client built-in, which de-risks the technology development process.
Some of the new tools that have been developed include new “Sensor Sticks” made by PreSens which measure dissolved oxygen, partial pressure of carbon dioxide and pH levels rapidly and accurately within bioreactors; new and improved glycan assay tests developed by PAIA Biotech using special microplates for high throughput assays; a new cell density quantification tool put forward by IpraSense that gives automated high throughput cell count and viability determination; and monitoring methods by Kantisto to better quantify various components of the cell culture and of the media used to grow the cells.
“Some of the tools are already commercialised by the different partners,” says Chotteau. “For the new technologies which are coming more directly from iConsensus, we will need additional time to go from the developed prototype to create the real commercial product.”
“We are at the stage where we have proof-of-concept of most of the technology, so we have shown that this technology works. The next step is to get this now from a piece of equipment that works, but is not so user-friendly, into a packaged product that you can sell and say, with this you can do the measurements,” says Kupers.
The technologies are not only useful for protein production, but could also be used in the evolving therapies of the future.
“[These tools] can also be used to produce cells and viruses that are used as therapy themselves,” says Kupers. “Like the newer cancer treatments where you manipulate the cells. You grow the cells outside of the patient, then you give them back manipulated. You still need cell culture media to grow the cells, you have to be sure that the cells are all more or less identical, so that is another application of the iConsensus technology.”
iConsensus is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.