Monitoring of Ultrafiltration/Diafiltration (UF/DF) in Bioprocessing
Ultrafiltration (UF) and Diafiltration (DF) are membrane-based separation processes widely used in biopharmaceutical manufacturing to concentrate and purify monoclonal antibodies (mAbs), recombinant proteins, and other biologics.
1. Ultrafiltration (UF): Used to concentrate biomolecules by removing solvent and small molecules while retaining larger proteins.
2. Diafiltration (DF): Used to exchange buffer components, remove impurities, or desalt formulations by adding fresh buffer while simultaneously removing small molecules.
These steps are typically performed together (UF/DF) as part of downstream processing, preparing biologics for final formulation and stability.
Traditional UF/DF monitoring methods lack timely quantification, making it difficult to optimize buffer exchange efficiency and maintain product consistency....
With our cutting-edge FTIR-based technology, we provide rapid insights into UF/DF buffer exchange, allowing for:
- Accurate quantification of buffer components and API concentration throughout the process
- Near Real-time detection of excipient removal and buffer exchange efficiency
- Process optimization to prevent protein aggregation and formulation inconsistencies
- Monitor protein secondary strucutre stability
The data below illustrate how individual buffer components and the mAb are tracked with the QA Scan throughout the UF/DF process. Component A, B, C, D, and E represent different excipients, while the mAb concentration increases in UF and remains stable during DF. Data is normalized to a scale of 0 to 1. CLADEs QA Scan ensures that all parameters are measured within minutes, enabling rapid adjustments for maximum process efficiency.
Turn UF/DF from a blind process into a data-driven operation. Achieve better control, reduce variability, and optimize purification with ultra rapid quantification.
Optimize your UF/DF process today! Contact us to learn more.
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