Going Viral: Oslo University Hospital & SCTbio

The STEAP1 CAR-T cell therapy project represents a high-stakes collaboration between Oslo University Hospital (OUH) and SCTbio. Led by Prof. Jon Amund Kyte, the program aims to advance a STEAP1-targeted CAR-T therapy in solid tumors where accessibility and immune suppression remain among the greatest challenges in modern oncology. By combining OUH’s cutting-edge research with SCTbio’s expertise in GMP-grade viral vector production, this partnership provides a cost-effective path to Phase I trials. The preclinical development of the STEAP1 CAR T product has been performed by Dr. Yixin Jin and colleagues at Kyte Group, Department of Cancer Immunology, OUH.

Dr. Claire Dunn, senior cancer immunology researcher at OUH, manages the project’s translational work. The department supports Norway’s push to make advanced treatments more accessible through initiatives like IMPRESS-Norway and the support of leaders like Prof. Johanna Olweus and Prof. Karl Johan Malmberg, recent recipients of the King Olav V Prize for Excellence.

"The clinical trial will use the virus produced by SCTbio," Dr. Dunn explains. "At this stage, the plan is to assess its safety in patients with either Ewing sarcoma, which predominantly affects young people, or prostate cancer, which generally affects older men; in both cases where therapeutic options remain limited."

To bring this vision to life, OUH required a partner capable of navigating complex technical and regulatory landscapes.

Enter Dr. Lucie Polovinkin, SCTbio’s Head of Technical Proposals and Project Manager, whose deep background in process development makes her not only technically fluent but also hands-on in bridging scientific innovation and commercial execution.

"We didn't just provide standard pipeline services," Dr. Polovinkin notes. "When OUH brought us their highly specific STEAP1 construct and envelopes, we used our technical expertise to make it work. We adjusted directly to their clinical needs, optimizing a complex production and quality control platform for them."

How Lucky We Were

While academic budgets are notoriously rigid, choosing a CDMO based only on the lowest bid can create costly downstream problems. OUH, supported through tech transfer office Inven2, needed affordability, but required a partner aligned with EMA requirements.

"Cost was a major factor: as an academic institution, we have a limited budget, which can be a barrier with larger providers," Dunn says. "It was important to us to have a producer in Europe, under EMA-aligned governance, because the Norwegian Medicines Agency generally aligns with the EMA."

OUH evaluated importing from the United States or Asia, but the regulatory friction was simply too high. For geopolitical stability and risk mitigation they kept the supply chain in Europe to avoid tariffs and extra auditing responsibilities.

"We did look at providers in the U.S., but the advice we received was that we would probably still have to import it into the European Union under EMA before bringing it into Norway." Dunn explains. Similarly, evaluating CDMOs in Asia presented comparable hurdles.

"They said they were EMA-compliant, but they were not EMA-audited, and from our side that is a big difference because it adds extra auditing responsibility for our facilities. We actually discussed how lucky we were to work with someone here in Europe," Dunn adds.

SCTbio offered competitive pricing, optimized processes, and a transparent, can-do attitude.

"We were willing to go the extra mile to help them develop their process and make it work with their viral vector at a very reasonable price," Polovinkin explains. "From the beginning, OUH could probably see that the collaboration would work well. They saw that we were responsive, delivered on our commitments even during early negotiations, and offered administrative flexibility to save them extra tax fees”.

Losing 90% of the Vector

The STEAP1 project relies on a gamma-retroviral (gRV) platform with an uncommon RD114 envelope, selected among three alternatives as the best performer. This setup presented unique manufacturing challenges. Although much of the industry trends toward lentiviral vectors (LVVs), legacy data made gamma-retroviruses the right choice, and SCTbio’s expertise in both gRV and LVV platforms meant OUH did not have to scrap years of research to fit a CDMO’s rigid pipeline.

"Because we had already generated all of our in vitro and preclinical data with the retrovirus, we did not see the point at this stage of restarting the whole project with lentivirus," Dunn confirms. "Gamma-retroviral vectors are already accepted for producing CARs in the clinic, so we decided to continue with that technology."

Scaling up an uncommon envelope like RD114 led to hurdles in sterile filtration that resulted in substantial losses during the first runs. Standard CDMOs might have walked away, citing filter incompatibility.

Instead, the SCTbio team—led by Dr. Tomáš Kroupa, Manager in Process Development and Subject Matter Expert in viral vectors—customized buffer compositions and used Tangential Flow Filtration (TFF) and VideoDrop monitoring to optimize the process.

"At the very beginning, we were losing 80 to 90 percent of the vector. Now, we have reduced that to a 40 to 50% loss," Polovinkin states, noting that hitting 40% is an outstandingly minimal loss for such a complex process. "It would have been foolish to expect a highly particular process to work perfectly on the first try... we persisted, and we eventually made it work by using a different filter."

By using VideoDrop to confirm the virus remained monomeric rather than aggregated, SCTbio spared OUH extra manufacturing runs.

"By verifying this, we ensured that our manufacturing at scale is truly cost-efficient for the client," Polovinkin adds.

The Biggest Shock

Moving from academic R&D to GMP is a major shift, both culturally and financially.

"The cost of everything, honestly... Once I got that exposure, the scale of the costs in the clinic was astonishing," Dunn shares candidly. "We were trying to save on a 100-euro vial of antibodies while other items could cost 100,000 euros. That was the biggest shock."

Moreover, proper Quality Assurance (QA) and Quality Control (QC) require far more rigidity and documentation.

"In academia, we are used to being able to adjust things as we go, but GMP work is much more structured, with strict guidelines and full documentation," Dunn observes. "We do not have an in-house Qualified Person (QP) to sign off on import, so it was very important that you could provide QC testing and have someone familiar with the process who can release the virus under EU rules."

Because SCTbio is a comprehensive one-stop shop, the partnership expanded naturally. While OUH carried out cell manufacturing in-house, SCTbio was positioned to provide end-to-end support from process development and vector production through GMP manufacturing, QC, QA, and QP release. SCTbio focused on downstream integration, from vector copy number testing by dPCR to consulting on transduction optimization.

"The differentiator is how much we handle in-house and how supportive we are along the way," Polovinkin explains. "Because our experience extends beyond just the vector, we can develop and qualify assays for their final CAR-T product, which standard viral vector producers would not do."

This transparent, collaborative approach resonated with the OUH team.

"They are open and willing to clarify any basic question we ask,” Dunn says. "If there is a challenge, they come back with a solution rather than just saying something went wrong."

Avoiding Commercial Traps

OUH plans to manufacture its CAR-T cells in-house for Phase I, while the roadmap for Phase II and III remain open. As Dunn notes, scaling beyond human trials will require new funding and partnerships. This transition is critical for academic sponsors: hospital facilities can support early local trials, but developers eventually need infrastructure capable of supporting multicentric trials to avoid major cost and logistical barriers. SCTbio advises early-stage developers to plan ahead by securing a partner that offers both cell manufacturing and vector production.

"If you manufacture CAR-T cells but receive the viral vector from an external supplier, you are required to qualify the external producer to ensure GMP compliance," Polovinkin warns. “Very few companies offer both, like SCTbio, but keeping everything under one roof offers massive benefits: it eliminates qualification steps, avoids shipping hundreds of product bags, and centralizes storage; all under a single contract, point of contact, and synchronized timeline.”

Furthermore, rushing to sign with a basic, disconnected vector supplier for early research can lead to what Polovinkin calls a "commercial trap".

"Once data are generated with that supplier, restrictive licensing fees can make it very expensive to transfer vectors or outsource to a different manufacturer later,” she notes.

Start Early!

Academic teams moving from the lab to the clinic often struggle to find the right partner at the right time; so early engagement and careful CDMO selection are essential.

"Start as early as possible," Claire Dunn advises. "Be cautious about options that look cheap on the surface until you understand what is and is not included... identify your partner early, then work together to keep development smooth."

Lucie Polovinkin echoes this sentiment, emphasizing the long-term value of expert guidance:

"Even if upfront cost seems high, early consultation pays back through better timelines, budgets, speed, and troubleshooting. Partnering with an expert team early on saves developers from massive operational headaches later in the project."