Proof of Concept: Discover how we enhanced monoclonal antibody (mAb)?production in downstream processing

Proof of Concept: Discover how we enhanced monoclonal antibody (mAb)?production in downstream processing

Introduction: Reshaping Bioprocessing with PAT

The biopharma industry is constantly seeking innovative tools to improve efficiency and precision in biomanufacturing. Monoclonal antibodies (mAbs) demand careful monitoring during downstream processing to maintain quality and ensure consistency. In collaboration with Merck Serono Healthcare, we showcased how our cutting-edge Process Analytical Technology (PAT), Monipa, enables successful monitoring of mAb concentration after purification steps.

The Study: Inline Monitoring after Chromatography Step

Traditional methods of monitoring mAb concentrations often involve offline sampling, which can be time-consuming and prone to delays. Our Monipa was connected inline to the chromatographic system, ?kta Pure, providing continuous, real-time measurements.?

  • Accuracy:?Inline measurements closely aligned with offline references, demonstrating a Root Mean Square Error (RMSE) of 0.24 g/L and an R2 value of 0.9888.
  • Efficiency:?Eliminating the need for manual sampling accelerated the process and reduced variability.

The Impact: Accelerating the Production of Life-Saving Medicines

Biopharma continues to innovate every single day. Every breakthrough brings us closer to transforming patient care, but it also demands novel solutions. By avoiding manual sampling and providing real-time results, our technology not only improves accuracy but also accelerates critical bioprocessing steps. This positions Monipa as a trustworthy solution for tackling the industry’s growing demands.

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Want to explore more how Monipa can elevate your bioprocesses??Click below?to read the full study:

Marasca et al. Towards continuous biomanufacturing: Real-time monitoring of protein concentration in downstream processing by mid-infrared spectroscopy. Poster presented at: BPI Europe 2023; May 9-12, 2023; Amsterdam, the Netherlands.


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