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Production of biopharmaceuticals in a large-scale continuous process tested by CBH researchers

Forskare i labb.
Veronique Chotteau och fyra doktorander i labbet på AlbaNova. Foto: Jon Lindhe, KTH
Published Apr 28, 2021

Researchers at the CBH School will make an attempt to produce a continuous process for the production of biopharmaceuticals on an industrial scale. The trial is the first of its kind in Sweden.

”There are very few sites where this has been performed so far, so we have unique prerequisites here. We hope to be able to prove that the concept we have developed works well and learn more about how to scale up these kinds of processes. We want to demonstrate the capacity we have in Sweden when it comes to producing this kind of process” says Veronique Chotteau, researcher and director of the competence centre AdBioPro.

Biopharmaceuticals are pharmaceuticals produced from cells, which are used for treating diseases such as cancer and diabetes. Production through continuous processes instead of batch production, is a method which is increasingly in demand, not least from the pharmaceuticals regulatory authorities in the European Union and the United States.

“You can multiply the process very fast and in many parts of the world, so it is a way of having very good flexibility from a small need to being able to produce very much. It is a field which has become popular in recent years and forms a basis for the technology we have within this competence centre” says Veronique Chotteau.

New ways of producing biopharmaceuticals

AdBioPro is a Vinnova financed competence centre aimed at finding new ways of producing biopharmaceuticals, composed of leading researchers from KTH Royal Institute of Technology, Karolinska Institutet and Lund University, in collaboration with industry.

During May, professor Sophia Hober at the CBH School, professor Bernt Nilsson in Lund and the centre’s director Veronique Chotteau will try to produce a continuous process for producing a well-known antibody used to treat breast cancer at the test facility Testa center in Uppsala. A bioreactor for cultivation and three ÄKTA devices for automatic purification will be interconnected in the trial, which will be carried out by four doctoral students.

”We will do a proof of concept at pilot scale. We achieve a cell density that is very high, 100 million cells/ml, which is around five times higher than what you usually have in an ordinary batch process. To do it continuously is a challenge in itself. From Lund University, an optimisation of the system is added, which enables the flow” says Veronique Chotteau.

Benefits the patient

In the trial, a new kind of ligand will be used in the purification process. It has been developed by professor Sophia Hober’s team and uses calcium, which makes it more gentle on the antibodies than the original molecule, protein A, which requires a very low pH value.

Besides being more economically efficient and having a greater flexibility and production capacity, continuous processes lead to a better control of pharmaceutical quality, which in the end benefits the patient.

“Since proteins are produced from living organisms, the result can vary a good deal in the end. With the help of continuous processes, the same conditions are maintained throughout the process. You can also use a lot of disposable materials, which also has its advantages. Surprisingly enough, disposables based on plastic are much better for the environment than equipment in steel. The huge facilities that are the alternative require an incredible amount of energy and water” says Veronique Chotteau.  

Text: Sabina Fabrizi

Contact Veronique Chotteau

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Belongs to: School of Engineering Sciences in Chemistry, Biotechnology and Health (CBH)
Last changed: Apr 28, 2021