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12.06
2023

Cell therapy: Overcoming the manufacturing bottleneck through automation

Cell therapy has the potential to cure virtually any disease, including cancer and HIV. But right now, it’s very expensive and there isn’t enough manufacturing capacity to reach all the patients who could benefit from the treatment. Luc tells us more about co-founding Limula – based at Biopôle’s StartLab – to help solve the manufacturing problem in this sector.

Where did the idea for Limula come from?

It all started in 2018 when my Co-Founder, Yann Pierson, met a clinician working on CAR-T cell therapy at the University of Geneva. This professor spoke about the difficulty of producing sufficient cells for future clinical trials. Yann realised the bottleneck was hugely limiting in this sector and there was a considerable appetite for innovations that could lead to scalable production and more patients getting access to a cure.

In true ‘garage start-up’ fashion, Yann spent months at home working on a first concept and prototype before filing a patent. In the late summer of 2019, he showed me a video of his invention and asked whether I thought I could help him unlock its potential. I’m a chemist by training but had been involved in synthetic biology and immuno-oncology research for a few years, and suddenly I had found a real-world application for these methods that could have a huge impact on patients. So I quit my job and have never looked back.

How does your tool help patients who undergo cell-based therapy?

The production of cell therapies is currently very manual: stem cells or immune cells are collected from the bloodstream, frozen and shipped to a pharma manufacturing facility. The engineered cells are manufactured there using multiple devices, frozen again and shipped back to the hospital where the patient is waiting. It’s a very complex and expensive process and there just isn’t the capacity to bring this treatment to all the patients who need it.

We believe widespread access will only happen when we have a scalable and standard process. Limula provides a tool that automates multiple steps to increase manufacturing capacity. We deliver process intensification by removing some manual steps and decreasing the amount of equipment needed for a given process.

Team of Limula with Nasri Nahas at StartLab

What’s unique about it?

Our tool is a centrifuge and a bioreactor at the same time. It brings together cell washing and concentration, cell separation and incubation. Since every step of cell manufacturing involves either cell processing or cell culture, this means we can alternate between the two functions in a way that’s fully automated and can sequence steps without human intervention. Keeping cells in the same container at all times is what’s unique and what’s most valuable to our customers because it decreases the risk of cell loss and product contamination.

Are automated tools like yours likely to replace jobs?

Our tool replaces the need for multiple skilled workers to be involved in the production of a dose. We intensify the process so that our customers can package more manufacturing units within the same space. Instead of a team of technicians doing one patient treatment per day in a clear room space, they could do ten in parallel. So it will be the same facilities and number of staff, but the output could be a lot higher. Rather than taking jobs away from humans, we’re empowering them to focus on added-value tasks where their critical thinking and expertise are used to serve more patients.

Is cell therapy a crowded market?

The market is still relatively small, with a total value of almost USD 4.8 billion in 2022. But it’s projected to keep growing fast. The number of companies engaging in the development of cell therapies will also grow. This is driven by increased funding for clinical studies, more clarity in the regulatory frameworks and the market success of novel products. Today the market includes big players like Novartis as well as small start-ups, but it will take many different players to advance cell therapies. There are opportunities to make progress in many areas: clinical efficacy, supply chain, hardware and software for automation.

To innovate on all these fronts, we’ll need collaboration between different players bringing their own technologies and skill sets. It may often seem a company is our ‘competitor’ because we claim the same vision and goals, but on closer inspection, we’re highly complementary. We should work together because others have a piece of the puzzle that Limula cannot bring and vice versa.

Who are your customers?

Today, they’re research departments in hospitals and in biotech working on pre-clinical studies. There’s been a realisation in the industry that one needs to think about cell therapy manufacturing at a very early stage of development. Clinicians and biopharma companies can carry out trials and get very good results in patients, only to realise they rely on a manual manufacturing method that will never scale when their therapy receives regulatory approval. Thanks to our technology, we help anticipate the scale-up production of their treatment so that they’re ready, by the time they enter a clinical trial, with a method that is robust and can be taken to commercial stage.

There is new clinical evidence published constantly, both positive and negative, so we need to strike a balance between taking new studies into account while having a stable goal to work towards.

Since cell therapy is complex and costly, when does it make sense to use it?

So far, the focus has been on patients suffering from untreatable, rare diseases or from aggressive forms of cancers after all other available treatments have failed. In these cases, you can justify the high costs of a curative solution. But there’s a clear market shift happening with cell therapies being used in more common conditions or as an earlier line of treatment. As they become safer, cheaper and more accessible, there will be fewer reasons to wait for the patient to be desperately close to dying before using these curative methods.

What has your biggest challenge been?

Cell and gene therapy is a relatively young field, with the first commercial product getting regulatory approval only five years ago. So it’s a challenge to navigate this emerging market when making decisions, as there’s very little historical data to look at. We had to decide what kinds of cells to work with and what data to collect to develop technology that’s as effective and differentiated as possible. There is new clinical evidence published constantly, both positive and negative, so we need to strike a balance between taking new studies into account while having a stable goal to work towards. Another challenge is to get investors on board who are not necessarily familiar with the sector but are very aware of the risk of immature markets.

Limula was selected for the Biopôle Start-up Fund and has just raised CHF 2.5 million. What’s next?

The good news with these funds is that we can start our transition from a functional prototype towards a product we can sell. This year, we want to drive industrialisation forward and end up with a minimum viable product that our customers can use in their labs to produce clinical-grade cell materials – in other words, cell material they could eventually use in patients. For this to happen, we need to meet strict quality criteria.

How do you see your start-up in five or ten years, in a context where researchers are aiming to develop off-the-shelf cell therapies or in-vivo induced CAR-T cells?

There will always be room for different types of treatments for different indications. I don’t think one will replace the other completely. We are also trying to be as flexible as possible with the tools we develop so that they can address different types of cell therapy in the future.

In five years, Limula will have a first-generation product on the market with enough users to be a sustainable company. We already have an R&D pipeline that will lead to a second, more complex product that will bring even more value to our customers. In the end, what we really want is to create tools to give more patients access to these therapies. It’s going to be a collective endeavour across the industry, and we’re doing all we can to play an important part in this revolution.

Complementary content

Luc Henry
Co-Founder and CEO of Limula

As Co-founder and CEO of Limula, Luc Henry builds meaningful partnerships to maximise the impact of the company’s technology. In 2022, Luc and his team moved from the EPFL to join the shared lab space at Biopôle’s StartLab. Before launching Limula, Luc spent four years as a personal advisor to the President of EPFL, Professor Martin Vetterli. He is a skilled scientist, with ten years of research experience in chemistry, biotechnology and immunology, holding a PhD in Chemical Biology from the University of Oxford. Luc has launched and successfully led several entrepreneurial projects at the interface between life sciences and innovation.

Biopôle Start-Up Fund
Launched in 2021, the Biopôle’s Start-up Fund is a flagship initiative that helps the most promising life sciences ventures on campus to focus on what they do best. With up to three years of support with the costs of rental, research and development and key services, Biopôle SA supports entrepreneurial passion and early-stage innovation. The fund’s primary goal is to encourage start-ups that show scientific impact and growth potential. Companies are chosen based on scientific excellence, the relevance of their business model and the quality of founding and management teams.
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StartLab
StartLab is a fully equipped, shared laboratory that offers state-of-the-art infrastructure, equipment and offices. The 1,500 m2 space is tailored to companies operating in wet-lab biology and chemistry environments for drug discovery, diagnostics, synthetic biology, medtech and other areas of the life sciences. The lab is fully licensed and managed by a dedicated on-site manager. Regular events are organised to create collaboration opportunities among members. Since 2018, StartLab has hosted more than 40 diverse start-ups who benefit from a flexible pricing model that can be reviewed on a quarterly basis.
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