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• mAbsizer™ Calculator

  mAb Expression, Purification, and Formulation

• Application Note: Cell Culture Media Filtration – Filter Selection and Sizing

  This document discusses the trend in bioprocessing to enhance productivity upstream through improved cell culture media processing, highlighting the challenges posed by concentrated and complex media that can lead to premature fouling of membrane filters. It emphasizes the importance of selecting the right membrane filter, particularly addressing microbial retention, and explores the trade-offs between different filter options such as traditional sterilizing-grade filters and mycoplasma-retentive filters in minimizing bioreactor contamination risk.

• Application Note: Cell Culture Media Filtration - Evaluating Cell Culture Performance

  This document addresses the challenge of efficiently processing highly concentrated and complex cell culture media, emphasizing the benefits of membrane filtration in reducing the risk of bioreactor contamination. It discusses key considerations in selecting membrane filters based on microbial retention, compatibility, and capacity for specific media.

• Technical Note: Demonstrating Millipore Express^® SHR Mycoplasma Clearance Capability at Pilot and Production Scale over an Extended Filtration

  Two studies were conducted to assess the mycoplasma retentive properties of Millipore Express^® SHR with Prefilter filters using Acholeplasma laidlawii ATCC^® 23206™, simulating typical processing parameters and operating pressures. The studies demonstrated that the filters, in both production scale and pilot scale configurations, were fully retentive when challenged with A. laidlawii at low organism challenge levels over extended filtration times.

• Application Note: Integrity Test Troubleshooting – Beyond Rewet and Retest

  Integrity testing is crucial for sterilizing grade filters in biopharmaceutical processing, offering a fast, definitive, non-destructive way to ensure filter retention performance. However, while non-integral filters are unlikely to pass the integrity test, there are numerous ways an integral filter can fail, leading to retests and potential productivity and product loss.

• Technical Brief: Extended Bacterial Retention Testing of Millipore Express^® 0.2 μm Filters in a Continuous Flow System

  The technical brief describes the microbial retention performance of sterilizing-grade Millipore Express^® SHF filters under continuous flow operations for up to 16 hours, addressing the limitations of traditional testing methods and providing a more comprehensive understanding of filter performance in real-world biomanufacturing processes.

• Technical Note: Mycoplasma clearance by Millipore Express^® SHR filters at pilot and production scales

  The Millipore Express^® SHR filters, equipped with a 0.1 µm polyethersulfone (PES) sterilizing membrane, offer enhanced microbial risk reduction, particularly targeting mycoplasma contaminants in cell culture media. Retention studies demonstrated that both pilot and production-scale filters consistently provided the expected level of mycoplasma retention over extended filtration times, affirming their performance under continuous flow processing conditions.

• PDF: Millpore Express^® Family Guide

  Millipore Express^® filters, featuring hydrophilic polyethersulfone (PES) membranes, are trusted for their sterilizing-grade filtration, high flux, and capacity, with broad chemical compatibility and ease of use for wetting and integrity testing. These filters are versatile, suitable for various biomanufacturing operations, including filtration of cell culture media, monoclonal antibodies (mAbs), vaccines, plasma, viral vector, and parenteral production at different scales.

• Durapore^® Family Guide

  Durapore^® polyvinylidene fluoride (PVDF) membranes are a trusted choice for various bioprocessing operations, including liquid sterile filtration, sterile tank and gas venting, and final sterilizing filtration, offering low protein binding, broad chemical compatibility, and low extractables. These membranes are versatile, suitable for applications such as filtration of cell culture media, monoclonal antibodies (mAbs), vaccines, plasma, viral vector intermediates, and ophthalmics, with the additional assurance of 100% integrity testing for all Durapore^® sterilizing filters during manufacturing.