Building capabilities and expanding service offerings within ATMPs

CCRM Nordic, a non-profit organisation supported by the Swedish government, provides the expertise and infrastructure needed to facilitate the complex development of Advanced Therapy Medicinal products, also known as ATMPs or cell and gene therapies. Based at GoCo Health Innovation City - where it’s building a new state-of-the-art GMP facility - CCRM Nordic is characterised by a collaborative approach, working closely with partners across academia, industry, investment, healthcare and other ATMP-focused initiatives.

Ongoing work in the laboratory. Photo: CCRM Nordic.

CCRM Nordic was founded on a mandate from the Swedish government to accelerate the development and commercialisation of advanced therapies. The organisation offers a wide range of services for ATMP development, from business creation and strategic advice to early-stage process and analytical development, as well as clinical manufacturing. As a key driver of Sweden’s national strategy to foster innovation and sustainable development in the pharmaceutical sector, CCRM Nordic is now investing in a new state-of-the-art development and GMP facility at GoCo Health Innovation City in Mölndal. Construction is expected to be completed in 2026, with production planned to begin the following year.

“The new 3 000 square meter facility includes cutting-edge laboratories for process and analytical development, GMP-compliant production suites, quality control labs and collaborative office spaces. While the lab space is a vital cornerstone of our work, it’s just one part of the story. Our support goes far beyond the lab, encompassing strategic guidance and CMC support,” says Stephanie Mattsson, Director of Venture Development at CCRM Nordic.

Since its launch in 2022, CCRM Nordic has steadily expanded its capabilities and service offerings, both in the lab and through broader strategic support. Stephanie Mattsson continues;

“We engage with companies and technologies in multiple ways, not only as a fee-for-service provider, but also as an investor and incubator. There’s a large value in having experts in several areas of ATMP development under one roof.”

A recent focus for CCRM Nordic’s Process and Analytical Development team has been to establish automated, closed CAR-T cell manufacturing processes using industry-leading platforms. In parallel, they’ve also developed quality control methods to measure critical quality attributes of CAR-T cells, while also conducting detailed cost analyses of these platforms, to support the development of commercially viable ATMPs.

Stephanie Mattsson, Director of Venture Development at CCRM Nordic. Photo: CCRM Nordic.

“We’re tackling key challenges in cell therapy manufacturing by improving scalability, flexibility, reproducibility and cost-efficiency, while expanding our expertise in measuring a wide range of critical quality attributes for CAR-T cells,” says Chao Sheng, Process Development Manager at CCRM Nordic.

“Our team is actively building in-house capabilities and expertise for manufacturing various cellular immunotherapies. We have chosen CAR-T cells as our initial focus, given they remain the most advanced and dominant modality in the cellular immunotherapy landscape.”

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Forefront of ATMPs

Chao Sheng brings deep expertise in cell and molecular biology and regenerative medicine, developed through his PhD training at the Institute of Zoology, Chinese Academy of Sciences in Beijing, China. In 2013, he moved to Germany to pursue postdoctoral research on human stem cells at the University of Bonn and the German Center for Neurodegenerative Diseases. In 2018, he joined Miltenyi Biotec, a world-leading biotechnology company, as Global Product Manager for Regenerative Medicine. In August 2024, Chao Sheng joined CCRM Nordic as Process Development Manager.

“At CCRM Nordic, I have the opportunity to continue to grow professionally while working at the forefront of ATMPs. My team is actively engaging with many industry-leading platforms for manufacturing CAR-T cells, as well as other emerging ATMP modalities such as NK cells, TILs, Tregs and iPSC-derived therapies. We are evaluating these platforms from both quality and cost perspectives, developing practical solutions to address real-world pain points faced by ATMP developers.”

CCRM Nordic has the expertise, tools and data needed to help companies develop effective process and analytical solutions for ATMPs. Although several CAR-T therapies have already achieved market approval, significant barriers still limit their broader adoption across countries and cancer types, according to Chao Sheng.

“Some of the most pressing challenges include high therapy costs, long distances to treatment centers and safety concerns. At CCRM Nordic, we’re working to overcome or mitigate these barriers. For example, by optimizing manufacturing processes and reducing the cost of goods, we can help make CAR-T therapies more affordable for patients and healthcare systems, while improving the safety profiles of CAR-T therapies.”

“Meanwhile, thanks to our proximity to treatment centers in the region, we can help minimize geographic distance and shorten vein-to-vein time, thereby improving patient access in Sweden and across the Nordics,” says Chao Sheng.

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Chao Sheng, Process Development Manager at CCRM Nordic. Photo: CCRM Nordic.

Collaboration with Precision BioAnalytics‍

Chao Sheng and his team at CCRM Nordic are working closely with Jens Björkman, Analytical Development Manager, to establish robust analytical methods and core technologies for new ATMP manufacturing processes. As a molecular biologist and civil engineer by training, Jens brings extensive experience from clinical diagnostics and contract research organizations (CROs), where he specialized in nucleic acid-based analytics. Together with Mikael Kubista, Robert Sjöback and Fredrik Adlercreutz, Jens co-founded Precision BioAnalytics - a company established to push the boundaries of molecular analysis. CCRM Nordic recently deepened its collaboration with Precision BioAnalytics through a strategic venture investment, strengthening their shared commitment to pushing the boundaries of analytical innovation.

“Right now, we’re focused on refining our proprietary methodology to extract critical information directly from the primary sample,” explains Jens Björkman.

“Our goal is to offer a more complete and accurate picture of what’s inside the sample by harnessing the precision and sensitivity of our approach. While modern analytical methods can detect a single target copy in a given sample volume, further sensitivity demands a fundamental rethink of the pre-analytical process. Something that our approach is built to address.”

The partnership aligns closely with CCRM Nordic’s mission and strengths.

“We are applying both our proprietary methodology and deep analytical experience to CCRM Nordic’s projects. Together, CCRM Nordic and Precision BioAnalytics offer truly differentiated and complete solutions to our customers,” says Jens Björkman.

Stephanie Mattsson highlights the successful collaboration with Precision BioAnalytics as a perfect example of how CCRM Nordic enables new platforms for other companies.

“Through our work and network, we can create new opportunities for others. It’s a win-win situation where we at the same time strengthen our internal capabilities and service offerings. Working with Jens and his team is a perfect strategic fit for us as an organisation,” concludes Stephanie Mattsson.