Sartorius, Sanofi partner to bolster downstream process

Germany-headquartered bioprocess vendor Sartorius will engineer, manufacture, and commercialize a platform after gaining access to French pharma giant Sanofi’s R&D services and patents related to its ICB prototype.

As per the agreement, Sartorius will leverage its hardware, consumables and process automation throughout all the stages of development to commercialization. The platform will be made available to Sartorius’ customers globally.

The ICB process aims to increase efficiency by enabling uninterrupted and steady materials flow, as opposed to traditional batch methods, and by integrating multiple unit operations into a lean process setup. It reduces the overall process footprint, leading to lower raw material and energy consumption, higher productivity, and less waste.

“Technological innovation is crucial for biopharmaceutical companies to significantly reduce the cost of drug manufacturing - while improving the environmental footprint of their operations – and ultimately getting life-saving drugs to patients faster,” said Jan Schäfer, head of separation systems at Sartorius.

“As the biologics landscape becomes more diverse, teaming up with Sanofi is an excellent basis for developing a unique modular platform that combines flexibility with the advantages of intensified bioprocessing. This collaboration will help Sartorius to further expand its position as a leading company in the field of integrated and continuous bioprocessing.”

The firms did not respond when contacted by this publication.

Industry focus on downstream process improvement

Having made significant advancements in upstream, the industry is focused on improvements in the downstream process as the next pressure point for the industry. Sartorius offers a wide range of applications for process intensification in both upstream and downstream.

During its Q1 2024 earnings call Sartorius CEO René Fáber said that the firm saw “quite positive, strong dynamics in downstream separation systems” driven by its chromatography systems.

Meanwhile, in December 2023, we spoke to Ger Brophy, chair of Avantor’s Scientific Advisory Board, on his predictions for improvements in bioproduction efficiency in the downstream process.

Sharing insights on achieving continuous downstream process, Brophy said, “There has been a lot of talk around this, and we have to realize that in any industry we very rarely see end-to-end continuous processes, and in pharmaceuticals to be able to define a batch is often critical. It’s easier from a regulatory point of view to have a discrete batch [especially when there are problems].”

“We also have to accept that with a lot of biologics, we don’t yet have full visibility on the molecular processes, so in the near future, we are going to look only at individual processes. For instance, we’ll need to look at continuous chromatography, protein A chromatography and fermentation, then perhaps we will explore if we can link these subroutines together.”