BRIDGE Sweden reaches milestone with first GMP-compatible cell line

"Developing a production cell line is often the first major and costly step for an early-stage company", says Niklas Berndt Thalén, Research Scientist in Protein Expression & Characterisation at the DDD platform, SciLifeLab.

The Drug Discovery and Development (DDD) platform at SciLifeLab has completed the first GMP-compatible cell line developed within BRIDGE Sweden. The milestone lays the foundation for the continued advancement of promising biologics projects within the national initiative.

Establishing a robust production cell line is one of the most critical and resource-intensive steps in biologics development. The cell line forms the basis for future manufacturing and is a prerequisite for advancing a project toward clinical development.

To develop the cell line, the DDD team, led by Niklas Berndt Thalén, conducted an extensive screening campaign and earlier this year delivered 3 grams of antibody from minipool material. This enabled the project to perform analytical and functional studies while the final production clone was being developed.

Productivities exceeding 7 grams of monoclonal antibody per litre

Following single-cell cloning, ten Research Cell Bank (RCB) candidates have been selected. The top-performing clones achieved productivities exceeding seven grams of monoclonal antibody per litre.

The team also performed stability studies, delivered a comprehensive analytical package for the production clone, and provided complete documentation verifying monoclonality. The result is a fully characterised and documented cell line ready for the next stage of development.

"This is a critical milestone. Developing a production cell line is often the first major and costly step for an early-stage company, which is why being able to offer GMP-compatible cell line development within BRIDGE Sweden is so important," says Niklas Berndt Thalén, Research Scientist in Protein Expression & Characterisation at the DDD platform, SciLifeLab.

First full-scale demonstration of the new cell line development capability
The milestone represents the first full-scale demonstration of the cell line development capability recently established at the DDD platform through BRIDGE Sweden.
The work was carried out with support from Merck Life Science, developer of the cell line platform used in the project.

"We received excellent support from Merck Life Science throughout the project. This enabled us to follow a strict, well-defined development process from start to finish. At the same time, we have worked extremely hard to build this capability and deliver our first project," says Niklas Berndt Thalén.

The completed cell line has also enabled the pilot project, led by Anna Dimberg's research group and the company Vascurie, to save significant development time and become better positioned for future financing and development activities.

"Our top-performing clones produce more than seven grams of monoclonal antibodies per litre without any process development, demonstrating the high level of performance we have achieved through this development effort," says Niklas Berndt Thalén.

Supports future biologics development in Sweden
In addition to delivering the cell line, the project has generated valuable expertise and established workflows that will support future biologics development projects in Sweden.

The next step in the BRIDGE Sweden development pathway is now underway, with the pilot project moving to Testa Center for process development and scale-up.

"We are not only delivering a successful cell line. We are establishing a reproducible workflow that connects cell line development at DDD with process development and scale-up at Testa Center. This makes it easier for future innovations to progress toward GMP manufacturing and clinical studies," says Niklas Berndt Thalén.

Building a framework for future innovations
Alexandra Patriksson, Project Manager for BRIDGE Sweden and CEO of Testa Center, comments on the milestone:

”The new cell line development capability at the DDD platform is enabling a more seamless development pathway for biologics projects in Sweden. By connecting cell line development at DDD with process development and scale-up at Testa Center, we are building a framework that will benefit not only today's BRIDGE Sweden projects, but also future innovations that need support on their journey towards manufacturing and clinical development," she says. 

Facts BRIDGE Sweden
• BRIDGE Sweden is a national initiative funded by Vinnova and Swelife.
• BRIDGE Sweden aims to strengthen Sweden's capacity for biologics development by connecting research infrastructure, innovation support and industrial expertise into a seamless development pathway.
• The DDD platform at SciLifeLab is responsible for cell line development within the initiative, while Testa Center provides process development and scale-up ahead of technology transfer and manufacturing.
• One of the BRIDGE Sweden pilot projects is being developed at the Stem Cell Center and the Pre-GMP Facility in Lund and will continue through the development pathway with support from Testa Center.