AdBIOPRO is conducting research at Sweden’s Testa Center in Uppsala that could lead to new, more efficient ways to produce biological drugs. Since eight of the top ten best-selling approved drugs globally are biologicals, creating more efficiencies in the manufacture of these medicines would have huge potential for the industry, and for patients.
Veronique Chotteau, professor at KTH Royal Institute of Technology and head of competence centre AdBIOPRO says: “We are probably the first in Sweden and the Nordic countries to achieve a "proof of concept" with an automated continuous bioprocess on a large scale.” From a purely technical point of view, building both purification and production in one workflow was complicated.
This achievement is important as it advances and accelerates the development of therapeutics by enabling new manufacturing processes. These are more important for biological medicines and the quality of the final product than for traditional chemical medicines. However, the manufacturing is today expensive and the demand for more effective, cheaper and flexible manufacturing methods is huge.
Veronique Chotteau says: “There are several benefits to a continuous process. It provides more efficiencies with higher product quality so that we get better yields from smaller cultivation volumes, which gives a larger amount of final product. A continuously automated process also provides better quality and increases the conditions for maintained quality during production.”
Both the US Food and Drug Administration (FDA) in and the European Medicines Agency (EMA) are requiring that production must be transferred to a continuous process. In addition, these processes have a much smaller footprint and require less investment from the beginning than traditional processes. Thanks to this, they can be applied to equipment with greater flexibility and scaled up in a crisis situation such as a pandemic.
This has been possible thanks to a close collaboration between Professor Sophia Hober's research group at KTH, and Professor Bernt Nilsson's research group at Lund University, they scaled up and automated a continuous bioprocess in one go - both upstream cell culture and purification, all controlled through a proprietary computer system.”
Sophia Hober says: “During the development process, from laboratory scale to pilot format, it was exciting and interesting to use and evaluate our newly developed purification matrix allowing us to purify biological drugs in a very efficient and gentle way. The new matrix has proven to have a smaller impact on the product than the variant that is traditionally used.”
Lotta Ljungqvist, CEO of Testa Center, says: “What AdBIOPRO has accomplished here at Testa Center is impressive and promising. It shows that Sweden is at the forefront in production of biological therapies.”
Watch a video about AdBIOPRO and Testa CenterAbout 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. www.testacenter.com
About AdBIOPRO and perfusion
AdBIOPRO, Competence Centre for Advanced Bioproduction by Continuous Processing, aims to become a leading international center for research and development in bioproduction technologies.
When biological drugs are manufactured and produced, living cells are cultured and the purified. Veronique Chotteau's research group at KTH specializes in perfusion, a culture method that means that the cells are constantly supplied with new nutrients and that by-products in cell culture are continuously cleaned away. The process is easily scaled up and repeated with the same result, which also becomes a quality assurance.