Upstream bioburden control focuses on preventing microorganisms from entering cell culture processes. Sterile filtration is routinely implemented to protect the bioreactor and upstream processes from contamination.
There are multiple media filtration options that deliver sterility assurance and high performance at every step. Filter selection is guided by risk analysis to identify the level of bioburden control required, the efficiency (throughput) of cell culture media processing, and the filter formats available. Before filter selection is finalized, acceptable performance of your cell culture process should be confirmed.
Millipore Express® SHR (Sterile, High Retention) filters contain one layer of 0.1 µm polyethersulfone (PES) membrane and are available with an optional integrated 0.5 µm PES membrane prefilter that protects the high flux membrane, preventing premature plugging. These filters typically offer ≥ 7.0 log removal of mycoplasma and sterilizing-grade performance.
Millipore Express® SHC (Sterile, High Capacity) filters contain two layers (0.5/0.2 µm) of PES membrane and provide superior throughput and capacity for plugging streams. These filters offer sterilizing-grade performance.
Durapore® 0.1 µm and 0.22 µm filters contain one layer of polyvinylidene fluoride (PVDF) membrane and provide high flow rates and throughputs. These filters offer sterilizing-grade performance.
Application Note: Cell Culture Media Filtration – Filter Selection and Sizing
Application Note: Cell Culture Media Filtration - Evaluating Cell Culture Performance
Webinar: Scale-up of High-area Filters for Microfiltration of Biological Fluids
Technical Note: Demonstrating Millipore Express® SHR Mycoplasma Clearance Capability at Pilot and Production Scale over an Extended Filtration Time
Application Note: Integrity Test Troubleshooting – Beyond Rewet and Retest
Technical Brief: Extended Bacterial Retention Testing of Millipore Express® 0.2 μm Filters in a Continuous Flow System
Webinar: Filter Integrity Testing Best Practices
Technical Note: Mycoplasma clearance by Millipore Express® SHR filters at pilot and production scales
Our filters are fully scalable, from small-scale tools to pilot and production scale manufacturing. Most are offered as disposable capsule filters, as well as cartridge filters for use in stainless steel housings. Some filters are offered in high-area formats which double the membrane area compared to standard area filters, without increasing filter footprint. Each filter is available with several connection options, providing flexibility for your specific process needs.
Our filters are supported by the Emprove® Program which provides three types of dossiers to support different stages of development and manufacturing operations such as qualification, risk assessment, and process optimization. The dossiers consolidate comprehensive product-specific testing data, quality statements, and regulatory information in a readily available format.
A critical aspect of mAb manufacturing, viral safety assurance relies on established “prevent, detect, and remove” principles. Learn how you can tailor them to your own production upstream and downstream.
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