Resolute columns are ideally suited for process purification in the biopharmaceutical industry. A patented nozzle valve provides all column functions required for packing, unpacking and running of the column in a closed system. Based on established and well proven designs, the Resolute column provides improved column performance and true linear scalability combined with reproducible column packing methods for today’s high performance media.
Pall continues to work closely with the biopharmaceutical manufacturing industry to advance the state of the art for both chromatographic performance and productivity. The packing process is controlled by a slurry packing system.
Single use technology is widely accepted in bioprocessing, with key benefits being the elimination of cross contamination, cleaning, and subsequent validation time and costs, providing greater system and processing flexibility.
Tangential Flow Filtration (TFF) is more complex than many other unit operations for which single-use approaches have been adopted. In TFF, cleaning of the TFF cassettes and system is essential to maintain flux and minimize the risk of cross contamination in a multi-product facility.
The Allegro system provides a platform onto which five single-use manifolds are attached. The five manifolds – feed, retentate, permeate, retentate biocontainer and recovery – are provided gamma irradiated and ready to install on the system.
The single-use flowpaths have incorporated single-use sensors where possible. These sensors are manufactured to defined tolerances and minimize downtime in system set up.
Tangential flow filtration (TFF) is well established in biotechnological applications for the concentration and diafiltration of proteins and cell harvest. However, the energy input to achieve the required cross flow rates is high and the generated shear effect can damage sensitive target molecules. Innovative dynamic filtration systems using microporous membranes may be used as an alternative.
The new PallSep Biotech System is suitable for the gentle separation of target molecules from complex process fluids containing high levels of biomass/particulates and high viscosity. The shear forces generated by Vibrating Membrane Filtration (VMF) are limited to a narrow layer on the membrane surface, thus the bulk of the process fluid is not exposed to the shear. In addition, the required cross flow is much lower when compared to other TFF technologies. The system allows for a dynamic membrane filtration with lower energy input and gentle processing of the target molecule with a low pressure drop.
The PallSep Biotech System consists of encapsulated 0.2 μm polyethersulfone (PES) filter modules with filter areas of 0.2 m², 1 m² and 5m², which allow for process development and full-scale production. The system is suitable for installation in GMP facilities for use in biopharmaceutical processes without compromising ease of use, flexibility, cleanability, safety or operating costs.
Cadence single-pass TFF modules and systems are used tconcentrate biomolecules. They alscan be used for salt-level reduction by concentrating followed by in-line dilution. Volume capacities range from several liters tthousands of liters. Single-pass TFF may be used tperform various steps in a wide range of applications in the biopharmaceutical industry, including: