Scaling Strategies

Easily Scale-up for Manufacturing and Scale-down for Validation using Viresolve Filters

The risk of viral contamination is common to all biotechnology products derived from cell lines. Viral contamination arises from the contamination of the source cell lines or from adventitious introduction of virus during production. In addition, virus contamination poses a threat to the safety of biopharmaceuticals derived from human plasma sources.

Manufacturing processes must provide clearance of endogenous and adventitious viruses for product safety. If a scaled-down model of the purification scheme is used for this validation process it should accurately reflect the actual scaled-up manufacturing process. Flow rate, volume to membrane area, pressure and protein concentration are critical parameters to monitor and control from a scaling perspective.

With Millipore’s newest Viresolve NFP products -- the OptiScale-25 Disposable Device and 4-inch Opticap Capsule with Viresolve NFP Membrane -- validation studies and Vmax process optimization studies are now even easier.

The linear scalable performance of these new filters provides an integral small scale platform that doesn't require assembly of membrane disks or venting. Just pressure wet (>30 psi) with buffer or water and you're ready for testing!

Millipore's family of Viresolve filters retain viruses and provide maximum product recovery. All Viresolve filters employ composite membranes to retain viruses by a robust size exclusion mechanism. Available in either tangential or normal flow filtration modes these single-use filters provide consistent viral clearance. Viresolve products have Drug Master Files to expedite validation and FDA approval for new biotherapeutic products. Visit our On-line selection guide to learn more.

Click on the links below to read more about these new filters, and how they can simplify your process.

Viresolve NFP Filters Data Sheet
The Use of Composite membrane size exclusion filtration to remove TSE infectious particles