Continuous biologics processing proof-of-concept produced

14-Dec-2021

The research was done at the Testa Center, a non-profit organisation owned by Cytiva

AdBIOPRO is conducting research at Sweden’s Testa Center, a non-profit owned by Cytiva, that the company says could lead to more efficient ways to produce biological drugs.

Veronique Chotteau, Professor at KTH Royal Institute of Technology and Head of Competence Centre AdBIOPRO said: “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.”

This process method could accelerate the development of therapeutics. Currently, manufacturing is expensive and the demand for more effective, cheaper and flexible manufacturing methods is huge, the company says.

Chotteau said: “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 FDA in and the European Medicines Agency (EMA) are pushing for production to transition to continuous models. In addition, the company says, these processes have a much smaller footprint and require less investment from the beginning than traditional processes. This also means they can be applied to equipment with greater flexibility and scaled up in a crisis situation, such as a pandemic.

The research was made possible through a collaboration between Professor Sophia Hober's research group at KTH, and Professor Bernt Nilsson's research group at Lund University. The teams scaled up and automated a continuous bioprocess together, with both upstream cell culture and purification controlled through a proprietary computer system.

Sophia Hober said: “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.”

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Lotta Ljungqvist, CEO of Testa Center, said: “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.”

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