Optimizing Product Purity
Product purity is optimized through effective washing out of contaminants during diafiltration, as well as during any sanitization and flushing steps. The Mobius FlexReady TF-2 system was designed to minimize deadlegs and contamination points through the use of novel low dead volume T’s in the recycle path, and through avoidance of flex lines that are longer than necessary. As shown in Figure 4, this results in a system that can achieve >4 log clearance of small molecules as modeled by a 12-diavolume buffer exchange of 150 g/L NaCL solution against water using a 2.5 m2 Pellicon 2 30 kD cassette.
Implementation of process-ready hardware systems containing single-use processing assemblies permits rapid facility start-up as well as ongoing operational flexibility. This study presents data demonstrating that a preengineered system for TFF can deliver optimal process performance in terms of yield, quality, and product purity through implementation of low working volume, excellent product recovery, effective mixing, and efficient removal of small molecules.
The Mobius FlexReady TF-2 system enabled greater than 98% product recovery from even the most concentrated model protein feedstock tested, while minimizing turbulence during mixing and recirculation to maintain high product quality. Greater than 4 logs clearance of small molecules during buffer exchange delivers performance that is equivalent to traditional stainless steel TFF systems.
The data demonstrates that pre-engineered systems combining process-ready hardware systems with single-use, application-specific fluid flowpath assemblies are an effective means of realizing the full benefits of single-use technology.