The new Mobius TFF assemblies are optimised for concentration and diafiltration applications in processes such as gene medicines, monoclonal antibodies, therapeutic proteins, and vaccines.
These assemblies are manufactured, assembled and validated prior to shipment, eliminating the need for customers to validate multiple products from multiple suppliers.
Drug manufacturers can therefore eliminate the requirement to develop, execute and report results of TFF cassette and system cleaning protocols and this reduced validation effort can save months of precious drug development time.
What is more, Mobius TFF assemblies eliminate the need for post-processing cleaning, a step that can consume as much as 33 per cent of the total TFF process step.
While some manufacturers maintain current manufacturing rates and reduce the process step time, others elect to increase throughput while not expanding the total process step window.
"The total operating costs of single-use TFF using Millipore's Mobius TFF assemblies compare quite favourably to the costs for traditional, multi-use TFF processing, especially for companies which run one to six batches with modest membrane area," David Rubin, product manager of Mobius Solutions at Millipore, told In-PharmaTechnologist.com.
"Additionally, the advantages of single-use TFF quickly expand when companies factor in the "cost of risk" associated with operating traditional multi-use TFF processing."
The assemblies are a complete, self-contained TFF flow path consisting of process container, tubing, connectors, and innovative disposable cassette manifolds that eliminate fluid contact from any reusable components.
The disposable assembly can be integrated into a complete TFF system that includes in-line monitors, process pump, filter cassettes and holder, and optional controls and instrumentation.
All assembly components arrive fully assembled, integrity-tested, gamma-irradiated if requested, and ready to install in a standard cassette holder.
Because the assemblies work in conjunction with Millipore's Pellicon cassette format, process scalability, robustness and performance need not be sacrificed.
The transition to Mobius TFF assemblies is nearly seamless as holder installation, new cartridge prep and TFF operation remain unchanged. When done processing, users of Mobius TFF assemblies do not have to clean nor prepare the cassette or system for storage as all components that contact the process stream are discarded after use.