Single-Pass VMF of Precipitated mAbs

Single-Pass, Continuous Purification of Precipitated mAbs Using Vibro^® Membrane Filtration (VMF)

Precipitation combined with Single-Pass Vibro^® Membrane Filtration (VMF) is a suitable alternative to Protein A chromatography in the continuous purification of precipitated mAbs, with VMF reaching target concentrations in a single step while maintaining high flux and stable long-term operation.

Cost-Efficient Alternative to Protein A Chromatography

Protein A chromatography remains the industry standard for mAbs purification, but comes with high cost and challenges with integration in continuous processes. A possible alternative is the precipitation of proteins followed by single-pass filtration. However, fouling often prevents conventional TFF from reaching target conversion in a single step, making it unsuitable for continuous processing. In contrast, VMF effectively mitigates fouling using vibrations, enabling low-cost, single-step purification of precipitated mAbs.

DSP Intensification at High Concentration & Flux

In flux stepping experiments, VMF maintained stable TMP at flux rates of up to 77.4 LMH and a conversion rate of 90%, corresponding to a 10× concentration factor. In comparison, open-channel cassettes could not maintain stable operation at more than 25.7 LMH under similar conditions, achieving no more than 1.1× concentration, while HF generally requires even lower flux rates to operate. By enabling the efficient processing of precipitated mAbs in a single module, VMF simplifies and intensifies downstream processing.

Stable, Continuous mAbs Purification

VMF demonstrated a highly stable process over 24 hours of operation at a constant permeate flux of 72.9 L/m²/h (85% conversion, 6.67× concentration factor) with no loss of precipitated hIgG.
The remarkably low TMP increase during the entire process indicates that much longer running times would also have been possible, confirming VMF’s suitability for continuous processing.

Gentle Filtration of Sensitive mAbs

Analyzing the particle size distribution of the redissolved hIgG indicates that using Vibro^® Membrane Filtration in single-pass continuous processing preserves product quality, with no observed aggregate formation and providing a purity profile matching the original feed.