Our latest industry leader interview is with Pascale Charbonnel, who tells us about how SCTbio supports customers through the cell therapy manufacturing chain.

In this instalment of our industry leader series, we speak to Pascale Charbonnel, Chief Business Officer of SCTbio. Pascale tells us about the work of SCTbio, how they collaborate with biotech developers, and why they are a great choice for outsourcing cell and gene therapy (CGT) manufacture.

Tell us about SCTbio

SCTbio is a cell-based therapy and viral vector contract development and manufacturing organisation (CDMO). Originally part of the SOTIO group, we spun out in 2022 and operate a Good Manufacturing Practice (GMP) facility in Prague, Czech Republic. Recently, eureKING, a French special purpose acquisition company, or SPAC, has signed an agreement to purchase full ownership interest in SCTbio, which will further bolster our position as a leading CDMO service provider.

As part of SOTIO group, we were developing our own cell and gene therapies for 13 years, so we have a lot of experience in manufacturing for clinical trials from phase I to phase III across multiple geographies. Given this expertise, customers trust us to guide them through the development process as they navigate the GMP world and clinical development.

What kind of customers do you support, and how do you support them?

Our target customers are mainly early-stage biotechnology companies, who typically outsource all their production needs. We are sometimes also used as an additional facility to absorb around 20-30% of the production needs for large Ph II / Ph III phases. Our main goal is to establish trust with customers right from the beginning, so we can then support them as the project progresses through later clinical phases. The average customer project takes about two years.

With our history in SOTIO, we can ensure GMP compliance for the full drug development life cycle as we have also faced some of those same hurdles associated with developing therapeutics. Our team understands the importance of saving time and costs, and maintaining momentum to ensure approvals run smoothly and that we can move onto the next clinical stage. We use this experience to create optimised development plans, which give customers the assurance that we can support them and hopefully go on this journey with them for many years to come.

How do you manage the data you generate for customers, and what formats do you report in?

We are still very much in a mixed model – so we have turned to electronic systems in some cases, but we do still have paper-based approaches too. It’s useful to have both, as it means we can tailor our approach depending on customer requirements. We’ve built our own data management system, which has been developed specifically to fit our operation here – so while there is scope for us to move to a full digital system, it will take time and our customers’ current requirements do not warrant that.

When it comes to customer data, we typically start by storing the raw data in a validated platform which we can then manage regularly. We then export it to the customer in whatever format they wish. As each customer’s requirements differ greatly, there’s no need for us to move to full digital systems yet, but it’s definitely something we’re bearing in mind for the future.

What does a typical audit look like, and how do you ensure success?

Since last year, we’ve run four audits – three by customers, one by a regulatory body. They all follow a similar process, where we will receive a request or announcement about two weeks in advance that an auditor is going to visit, and they usually request specific documentation which of course we already have to hand. During the day they will look at everything in our facility, speak to some of our technical staff, and then make a report outlining any observations.

GMP culture is very deeply rooted in our company, to the point where our recent regulatory audit returned no observations at all! While this shows everything was as expected, our customers were particularly impressed. One of our customers came back to us following their audit to say that they can see we go above and beyond the standard for GMP, and that our team is clearly well organised and collaborative.

How does SCTbio stand out as a CDMO?

One thing I think really makes us special is our people. We are a team of about 80 people, many of whom have been with us since the inception of SOTIO, and the staff turnover rate is very low indeed. It gives our customers a great deal of assurance that as well as having far-reaching experience in developing drugs and a deeply rooted GMP culture, our people are committed to our customers and get to know them and their needs.

What set us apart is our 13 years expertise in the CGT field and our flexibility to accommodate different sizes/stage of projects. We plan to stay very flexible, so that we can continue to take a bespoke approach to supporting our customers.

In addition, we offer a really wide range of services. We can collect the starting material, process it in our facility, release it under quality assurance / qualified person (QP/QA) and GMP conditions, and we have a logistical advantage as we’re based in central Europe, so close to a number of key markets. Being able to offer a full start-to-finish process in one place is quite unusual, so it gives us a strong advantage.

The recipe for success as a CDMO in my eyes is to have mutual trust and transparent communication with partners and customers, so with highly skilled people and low turnover, as well as the cost benefits of our location, our customers rely on us for consistency, reliability, and quality.

What do you think the future holds for cell and gene therapy?

The market has faced many challenges over the last few years, but we’re now starting to see an upturn. Funding is becoming available again, and we believe that ‘the good science’ will prevail. We’re excited to see what projects will come our way and to keep supporting customers to develop life-changing medicines.