The Spanish start-up Aglaris Cell is close to launching what it claims is the first bioreactor that cultures cells in a fully automated way, without using toxic additives. The device has attracted interest from the University of Oxford and pharmaceutical company Merck.
David Horna, one of the co-founders of Aglaris Cell, located in the Madrid Scientific Park (PCM), is in London this week to meet investors to secure a second round of funding. Horna, with partners, Miquel Costa and Manuel González de la Peña, created the company two years ago with the aim of developing a device that would automate stem cell cultures.
Last year, the entrepreneurs secured a first investment of around €1m from British business angels. They also caught the attention of ISIS, the University of Oxford's technology transfer office, which provides them with strategic and scientific advice.
Horna says that after four years of research and development, the prototype, called Aglaris Facer 1.0, patented in 2012 in Spain and in the process of obtaining its international patent, is ready to be introduced to the market.
The idea of developing this device came about when the partners, who worked in various fields of biotechnology, noticed that more industries were using cells and tissues in their production processes.
'We saw that the way live medicines from stem cells were being produced was highly manual, and so we came up with the idea of designing and developing a cell culture bioreactor that could automate the entire process,' said Horna.
He noted that there are other bioreactors on the market and some have been able to automate some of the stages in the process, but he claims his is the first to perform all the process stages in a fully automated way.
We came up with the idea of designing and developing a cell culture bioreactor that could automate the entire process
Until now, an additive called trypsin was usually used in this type of culture, however, trypsin can be toxic for cells and removes part of the membrane's proteins. Instead, Horna's development uses an iterative method of cell culture which enables the team to completely automate and remove the need for human involvement in the cell separation and washing stages, without using any additives.
'We have achieved this by using smart surfaces that make cell adhesion and de-adhesion possible depending on changes in the environment,' Horna said.
The team is currently finalising the developments that will make it possible to use the same device to produce genetically-modified cell lines for cellular reprogramming and gene therapies. These advances build on the work Horna undertook for his thesis on smart surfaces at the Spanish National Centre for Cardiovascular Research (CNIC) and the Sarrià Institute of Chemistry (IQS), which was published in the journal Advanced Healthcare Materials.
Horna explained: 'The process is as follows: before the culture, cells are taken from the patient, for instance, fat cells obtained through liposuction, and then the stem cells are extracted. The next step is to inject the cells into the bioreactor where they will grow. The end product is cells packaged in a bag.'
The device produces a higher quantity of cells and of much higher quality than if they had been produced through manual culture, as there is no need to use trypsin.
'We take much greater care of the cell and the culture quality; therefore the resulting 'live' medication can be far superior. These cultures are used in regenerative medicine therapies and cell quality is extremely important.'
The device produces a higher quantity of cells and of much higher quality
Horna believes that this advance will be 'extremely positive in cellular therapies as, apart from simplifying the process, it means the process can be repeated and carried out in a series. That means the batches can be the same throughout treatment, making the treatment better and lowering the risk of contamination.'
Horna explained that cell cultures are usually grown in laminar flow hoods and that, although these are highly-controlled environments, there is always a risk of contamination from some agent, like a dust particle, for instance. On the other hand, Aglaris Facer 1.0 is fully sealed and isolated from the external environment.
The device has two parts: the 'smart' part, which contains all the engineering components, the computer, valves, pumps and sensors; and the 'dumb' part, which contains the consumables. It is in this second part, which is like a disposable cartridge, that the culture is grown.
'It's important that this part is disposable because you must avoid cross contamination when working with 'live' medication,' he said.
'This gives us a massive advantage because, by changing this consumable, this means the device can have numerous different functions. Apart from the culture cartridge, we have another cartridge almost ready in which you will be able to modify, differentiate or reprogramme cells. You will be able to play with biology a little bit.'