Innovating Biopharmaceutical Manufacturing: Timegate’s Real-Time Solutions Transform Process Control

PicoRaman M3 Instrument and a add-on ProbePro Mini connected to the 50L bioreactor monitoring the upstream process.

The Testa Challenge has come to an end, and the data analysis following the on-site bioprocess has been completed. During the challenge, Timegate monitored the entire bioprocess, including both upstream and downstream processes. The talented bioprocess operators at the Testa Center, where the challenge took place, successfully carried out an industry-standard procedure for producing monoclonal antibodies, aimed at generating intermediate materials for antibody-drug conjugate (ADC) applications. The bioprocess involved several stages, including monoclonal antibody (mAb) production, filtration, and antibody purification through chromatography and downstream analysis.

Timegated® Analytical Tools Enhancing Bioprocess Control

Timegate CEO operating the Timegate system during the downstream monitoring.

PicoRaman M3 system, coupled with ProbePro Mini, was integrated into the bioprocess. During the upstream process, Timegate carried out continuous, in-situ bioreactor measurements. The Timegated® analytical tools were used to measure and predict several critical process parameters (CPPs) including nutrients such as glucose and glutamine, metabolites such as lactate, ammonia, and glutamate, IgG concentrations, and viable cell density.

In the downstream process, the goal was to identify and monitor the optimal cut-off point for product elution and polishing and changes in product quality, including the identification of protein aggregation. Continuous measurements were carried out from the downstream flow to differentiate the quality of material phases. Raman spectral changes were in line with the UV result.

Timegate analytical tools, PicoRaman M3 instrument and  ProbePro Mini, connected inline to downstream processing.

Remarkable Predictions by Timegated® Technology

The concentration predictions were in line with the reference Cedex results.

This challenge validated the accuracy and significance of Timegated® Technology in bioprocess monitoring and control. The results demonstrate that Timegated® Solutions truly revolutionizes biopharmaceutical manufacturing and quality control.

Read more about Timegate Solutions for biopharmaceutical manufacturing.

Timegate’s Testa Challenge Team

Timegate had a versatile team on-site in Uppsala, Sweden during the challenge. A Timegate expert carried out the data analysis after concluding the bioprocess and the challenge. Timegators thoroughly enjoyed their time on-site, and those back at the Oulu office were fully engaged in the journey as well.

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More About Testa Challenge

The purpose of the challenge was to accelerate the adoption of groundbreaking technologies in bioproduction.

The Testa Challenge is a high-level innovation event where companies can validate their technologies in a real bioprocessing environment. Participants gain access to an industrial-scale bioprocess, allowing them to evaluate the impact of their innovations on biopharmaceutical production, such as monoclonal antibody manufacturing.

The Testa Center, where the challenge is hosted, is a collaborative initiative between the Swedish government and Cytiva, aimed at advancing life science industry growth and improving biomanufacturing capabilities. The center provides a state-of-the-art environment equipped with pilot-scale bioprocessing platforms for producing biologics. It is a testbed for both industrial and academic research, supporting biopharma projects from development to industrialization.

We extend our sincere gratitude to Testa Center, Cytiva, and all the participants for their collaboration and contribution to this invaluable experience.