Today it’s not only about drug discovery. Production is also a hot topic, especially finding the ability, knowledge, and competence required to work successfully with advanced bioproduction of biologics in a continuous process. At the Swedish competence centre, AdBIOPRO, research specialists in both upstream and downstream processing from KTH, The Royal Institute of Technology, Lund University and Cytiva have joined forces and they have now demonstrated scaling up for a continuous process in the Testa Center in Uppsala.
Strong interactions between industry and academia stimulate innovation and competitiveness in industrial bioproduction. AdBIOPRO is a good example of how research can support industry and in the long run help improve access to novel therapeutics for patients worldwide. In this new project KTH Royal Institute of Technology, Lund University and Cytiva have come together to combine world-leading research in both continuous upstream and downstream production, as well as novel ligand design.
”AdBIOPRO is probably the first academic project to achieve this in Sweden, the Nordics and perhaps worldwide. We have shown that our research can really support industry and provide a better way of delivering the promise of biologics to patients,” says Veronique Chotteau, Associate Professor at KTH, Royal Institute of Technology, and Director of AdBIOPRO.
Assoc. Prof. Chotteau is an expert in the perfusion process, a cell culture method where cells are constantly supplied with new nutrients while the active product in the cell culture is continuously harvested and by-products washed away. This leads to lower capital investment and more efficient processes with higher product quality. Together with Professor Sophia Hober, KTH, and Professor Bernt Nilsson, Lund University and their research group members, they have successfully developed an automated, continuous bioprocess upstream and downstream in Testa Center.
“The collaboration between academic and industry research in this project is outstanding. AdBioPro´s setup in the lab is highly complex including continuous and connected bioproduction and, most notably, it is performed on a relevant production scale.
This is highly impressive, and I am very happy to have had this kind of project here in Testa Center”, says Jesper Hedberg, Director Testa Center.
The cell culturing process is connected with purification, and they have really pushed the limits of cell density. This has enabled the size of the bioreactor to be reduced to a smaller 30-liter scale while still achieve a yield of up to 30 grams of pure antibody per day.
”To run this kind of technically complicated experiment you need a lot of planning, but being creative and solving problems in new ways is both challenging and fun. I am proud and impressed what we have achieved together at Testa Center, combining the expertise from three different research groups with our industry partner Cytiva and with fantastic support from the highly skilled staff at the Testa Center,” says Chotteau.
Professor Sophia Hober agrees and says that she was amazed to see their newly developed affinity matrix as the antibody capture step in a continuous production and purification pipeline of Trastuzumab, and adds, for now, the affinity columns in the PCC have been recycled almost 300 times.
The Pharma Industry is a major contributor to Swedish exports. To develop AdBIOPRO into the premier research center in the world in this field is important for Sweden and Swedish industry. To enable large-scale production of biological therapies is one important goal and new methods and techniques that can be used by the industry need to be developed. By using the Testa Center AdBIOPRO can actually demonstrate that this is achievable to industry and that they can develop technologies so that the full promise of biologics for patients can be delivered.
”We hope that this can provide the inspiration for the industry to adopt new processing paradigms from the Competence Centre for Advanced Bioproduction”, says Bernt Nilsson, Professor in Chemical Engineering, Lunds University, and a partner AdBIOPRO.
About AdBIOPRO
AdBIOPRO, Competence Centre for Advanced Bioproduction by Continuous Processing, aims to become a leading international center for research and development in bioproduction technologies. The goal is to enable the large-scale production of biological therapies. The competence center currently consists of seven industrial partners, one hospital and two universities in close collaboration. Companies are SOBI, Cobra Biologics, Cytiva, CellProtect, Lab-on-a-Bead, BioInvent and Valneva. Karolinska Hospital, KTH and Lund Universty are non-industrial partners. AdBIOPRO is an important resource for Swedish biomedical industry, as well as for academic institutions. Academic partners, led by KTH, The Royal Institute of Technology, are world-leading in areas of bioprocess technologies for mammalian cell production, omics characterization, protein purification, gene therapy and data-driven modeling and process control. This enables AdBIOPPRO to focus on the imminent technology shift from batch to continuous processes and production of biological therapeutics. AdBIOPRO is financed by VINNOVA, Sweden’s innovation agency.
About Testa Center
Testa Center is a non-profit company owned by Cytiva. Testa Center is a major initiative between the Swedish government and Cytiva to secure the growth of the life science industry and its manufacturing capabilities. The main objective of Testa Center is to bridge the gap from discovery to industrialization. The center offers businesses and academia globally a modern, pilot-scale testbed for projects and education in the production of biological products e.g. monoclonal antibodies, peptides, protein, vaccine, and viral vectors (non-GMP, up to Bio-safety level 2 and 500 liters). In this flexible facility, assisted by the experienced staff, users can perform a wide variety of projects, including scale-up of parts of a process, or a complete process from frozen cell bank vial to purified protein. www.testacenter.com
About Cytiva
We are a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. We are nearly 8000 associates with operations in 40 countries. We are a trusted partner to customers who do things ranging from fundamental biological research to making life-saving vaccines, biologic drugs and novel cell and gene therapies.
Our vision is a world in which access to life-changing therapies transforms human health. Our everyday work leads us step by step toward this vision.
Our mission is advancing and accelerating therapeutics. We supply the tools and services – the pots, pans, soups and sauces – that help our customers do their work better, faster, and safer. Everything we do is essential to the entire process – from start to finish and in between. We advance the work of our customers for better patient outcomes.
