Producing antibodies on a production line

Koen Dierckx, CEO and co-founder of SimAbs, has been working in the antibody industry for some 20 years. He has therefore seen a great many batch reactors. ‘And I continue to be amazed that this technology is still being pursued so wholeheartedly’, he says. ‘Whilst more efficient and more sustainable platforms have been in development for years.’ One of those platforms was created and patented by Dierckx and four co-founders around 2019: the Smart Integrated Manufacturing platform for Antibodies (SimAbs), after which the company is also named. The crucial difference from those large batch reactors is that SimAbs, based on the UHasselt campus in Diepenbeek, goes about things in a far smarter way.

Soup

A bioreactor contains billions of cells that have been genetically modified to produce the desired antibodies. Those cells then secrete the product into the “soup” in which they float. That soup must subsequently be purified using a range of chromatographic and filtration techniques. ‘In a batch system, all of that has to happen in one go’, Dierckx explains. ‘Ours is more of an assembly-line platform. We continuously introduce nutrients for the cells, whilst at the back end the “soup” is immediately fed into the purification step.’

‘We need far fewer nutrients and far less energy to keep things running’

Koen Dierckx

The advantages are manifold, according to Dierckx. ‘First and foremost, sustainability: because our production units, at 500 litres, are considerably smaller than a standard 10,000-litre batch reactor, they have a smaller CO₂ footprint [up to one quarter less, calculations show – Ed.]. And this is possible because we need far fewer nutrients and far less energy to keep things running.’

Such a steady-state concept also benefits the quality of the product, Dierckx notes. ‘In a batch process, cells still need to grow, which means the situation is different at every moment. That can introduce considerable variability in the antibody product. With us, the cells – as long as we keep the rate of supply and removal of nutrients and product constant – always have a consistent environment.’

The speed of the assembly line is determined on the basis of the type of cell and the antibody that needs to be produced. ‘We can tune production very precisely to the wishes of the customer’, says Dierckx. ‘This also makes it possible for us to contribute to the production of personalised medicines – small quantities of bespoke antibodies for a very specific group of patients.’

Flexible

SimAbs was founded in August 2019 by Dierckx and his colleagues Bart Van Acker, Joachim Vandeput, and Tom Lokermans, and has since enjoyed a flying start – despite the Covid pandemic – thanks to subsidies from the Belgian government and private investors. And although pharmaceutical companies were initially somewhat hesitant – this was, after all, an entirely new method of antibody production – they were ultimately won over. ‘I think above all because of the flexibility of our technology. And because we are a small outfit, we are well-placed to respond swiftly to our customers’ needs.’

For several years now, the team – which now numbers ten people – has been licensing their platform to pharmaceutical companies. But since this year, a GMP facility has also been up and running in Hasselt, producing for customers. Output stands at 1 gram per litre per day. ‘In that regard, we are focusing primarily on biosimilars, generic medicines’, Dierckx notes. ‘This gives us the opportunity to demonstrate that our platform is a genuine improvement over batch reactors.’

‘As a small outfit, we can respond swiftly to our customers’ needs’

Koen Dierckx

Affordable

The applications of SimAbs as a platform are, according to Dierckx, extremely broad. ‘From cancer treatment to anticoagulants and even new diabetes therapies.’ They have recently received a follow-on subsidy to further upgrade the system. ‘We want to integrate the quality controls that normally take place after the process directly into the production line. This involves sensors that measure, for example, the extent to which the antibodies produced are clumping together. That is something you would rather not have in your product.’

In the future, an increasing number of bioprocessing companies will transition to assembly-line systems like that of SimAbs, Dierckx predicts. And he believes this is urgently needed. ‘At present, you see that roughly 80 per cent of the antibody market is located in the northern hemisphere. That is because batch systems are simply not affordable for the poorer parts of the world. The consequence is that antibody-based medicines are less accessible to patients in those regions. Our platform is cheaper, and on top of that more sustainable and more efficient than current technology. It can therefore be deployed the world over. We hope to be able to do our bit towards making that happen.’