Overcoming Challenges in mAb
Process Development
In monoclonal antibody (mAb) downstream manufacturing, obtaining critical process data in real-time can be challenging, often leading to inefficiencies and extended time to market. Monipa aids biopharma companies to tackle such bottlenecks by rapidly and accurately predicting antibody concentrations at key downstream stages such as Ultra-/Diafiltration (UF/DF). Through continuous and real-time data, it advances the monitoring of critical quality attributes to reduce variability and ensure consistent product quality across all batches.
Why inline downstream monitoring matters?
Prevents batch loss and reprocessing
Achieve expected excipients
concentration
Reduce process iterations leading to costs reduction
Gain process know-how to avoid Donnan Effect
Integration of Monipa into mAb Downstream Processing
Inline UF/DF monitoring with Monipa
UF/DF is one of the most effective separation techniques and a critical step in downstream processing for precisely achieving the target product composition. The process relies on a permeable membrane to selectively separate components as a specific volume of formulation buffer is exchanged. It can be divided into key stages:
Ultrafiltration 1
Has the protein reached the optimal concentration to begin buffer exchange?
Accurate timing of UF1 improves consistency and reduces process variability.
Accurate timing of UF1 improves consistency and reduces process variability.
Diafiltration
Is the buffer fully exchanged?
Moving beyond fixed DF volumes with real-time monitoring optimizes buffer usage.
Moving beyond fixed DF volumes with real-time monitoring optimizes buffer usage.
Ultrafiltration 2
Has the final protein concentration been achieved?
Preventing deviations at this stage helps avoid reprocessing or, in the worst case, batch loss.
Preventing deviations at this stage helps avoid reprocessing or, in the worst case, batch loss.
Ideal UF/DF Scenario
Related Assets
Replacing offline process control with instant inline data offered by Process Analytical Technology ensures tight control over UF/DF. Monipa is successfully used to determine protein and various excipient concentrations with inline measurements during UF/DF in mAb downstream processing. Get in touch with us to explore tailored applications to your processes!
Application Note (2022), IRUBIS GmbH. Germany
Inline monitoring of protein concentration with mid-infrared spectroscopy
Authors: Dr. Géraldine Baekelandt, Sarra Boutaieb, Vitalii Mozin, Anja Müller
Poster | 16. Prozesskolloqium (2020)
Non-invasive MIR Spectroscopy for Glucose Control and Monitoring during Fed Batch Phase
Authors: H. Marienberg, A. Müller, V. Mozin, L. Sykora, A. Geißler, A. Roth
