Skip to Content
Merck
HomeProductsPharma & Biopharma ManufacturingBuffer & Media PrepMedia Filtration

Media Filtration

Read more about

Icon depicting a blue filtration tank and control unit surrounded by stylized representations of water molecules and filtration media particles.

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.

Selecting the Right Filter for Cell Culture Media Filtration

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.

Related Resources

  • 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.

Page 1 of 2

Selecting the Right Filter Format for Cell Culture Media Processing

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.

QUALITY STANDARDS AND DOCUMENTATION

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.

Related Product Categories
Single-Use Mixers
Explore Mobius® single-use mixing solutions for pharmaceutical ingredient blending and process solution preparation.
Bioprocessing Cell Culture Media
Our off-the-shelf and customizable bioprocessing cell culture media (CCM) products enhance productivity in upstream mAb, vaccine, gene/cell therapy processes.
Bioprocessing Recombinant Supplements
Our recombinant cell culture supplements include albumin, transferrin, insulin, trypsin, NAO growth factors and transport proteins for production of mAbs and recombinant proteins, as well as cell and gene therapies. We also offer animal-derived products for IVD applications or downstream manufacturing.
Bioprocessing Mobius® Single-Use Bioreactors
The Mobius® Bioreactor family includes the bench scale (2 mL and 3 L), pilot, clinical and commercial manufacturing (50 – 2,000 L) single-use bioreactors that enable cell culturing capabilities from early process development through commercial batch production.
Buffer & Media Prep
Explore our solutions for process solution buffer and media preparation, including our Mobius® single-use mixing and Mobius® FlexReady solutions.
Sterile Filters
Secure microbial safety with sterile filtration and disposable filters. Choose the right sterilizing filter for effective bioburden control.
Related Applications
Cell Culture for Manufacturing
Biologics manufacture: Cell culture's role in therapeutic protein, antibody, cell therapy, and vaccine production.
Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing requires scalable solutions ensuring high therapeutic concentration and process safety for immunotherapy.
Gene Therapy Manufacturing
Gene therapy innovation requires integrated manufacturing, testing, safety, and compliance expertise from experienced partners.
Vaccine Manufacturing
From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.
Pharma & Biopharma Startup Hub
Your new molecule or therapy begins its journey here. Find solutions and resources to navigate your path to successful drug discovery, development, and commercialization.
Cell Therapy Manufacturing
Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.
Media Development
Media screening, optimization, and raw material quality dossiers minimize process variability and expedite qualification.
RELATED SERVICES
Viral Vector CTDMO Services
Millipore® CTDMO Services offer viral vector development and manufacturing for advancing cell and gene therapies.
Custom GMP Cell Culture Products
Our custom cell culture product design experts can offer advice and support as you scale your bioprocess from clinical to commercial supply, assisting with liquid products, dry powder products, selection of raw materials, quality testing, flexible product packaging, and product documentation.
Custom Pre-GMP Cell Culture Media
imMEDIAte ADVANTAGE® offers quick-turnaround custom media, accelerating development work and speeding molecules to clinical trials.
Cell Culture Media Stability and Testing Services
Our cell culture media stability and testing services can provide an assigned expiration date for custom products, or test for nutritional component data to optimize your bioprocess.
mAb Development and Manufacturing Services
With Millipore® CTDMO Services we provide deep expertise and flexible solutions across all stages of development and manufacturing for monoclonal antibodies, bi-specific antibodies, fusion proteins, or antibody fragments. From mammalian cell line and process development to media and feed screening, master cell banking, scale-up, and GMP clinical and commercial drug substance.
Customer Collaboration Labs for Bioprocessing Optimization
Optimize your biomanufacturing at M Lab™ Collaboration Centers, where customers explore, learn and collaborate to solve their toughest bioprocess challenges.
Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?