介質過濾
上游生物負荷控制的重點是防止微生物進入細胞培養過程。
為細胞培養基過濾選擇合適的過濾器
有多種培養基過濾選擇,可在每個步驟中提供無菌保證和高性能。過濾器的選擇以風險分析為導向,以確定所需的生物負荷控制水平、細胞培養基質處理的效率(通量)以及可用的過濾器格式。在篩選確定之前,應先確認您的細胞培養製程是否具備可接受的效能。
Millipore Express® SHR(無菌高截留)過濾器包含一層 0.1 µm 聚醚砜 (PES) 膜,并可选配集成式 0.5 µm PES 膜预过滤器,以保护高通量膜,防止过早堵塞。這些過濾器通常可提供≥ 7.0 log的支原體去除率和消毒級性能。
Millipore Express® SHC(無菌、高容量)過濾器包含兩層(0.5/0.2 µm)PES 膜,可為堵塞液流提供卓越的通量和容量。
Durapore®0.1 µm 和 0.22 µm 過濾器包含一層聚偏二氟乙烯 (PVDF) 膜,可提供高流速和高通量。這些過濾器具有消毒等級的性能。
相關資源
- Aseptic Filter Formats: Selection Guide
This technical article provides a high level overview of different formats available to help guide product selection.
- 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.
Selecting the Right Filter Format for Cell Culture Media Processing
我們的過濾器完全可擴充,從小型工具到中試和生產規模的製造。大部分濾器都提供拋棄式膠囊濾器,以及用於不鏽鋼外殼的濾筒濾器。有些過濾器提供高面積形式,與標準面積的過濾器相比,膜面積增加一倍,但不會增加過濾器的佔地面積。每種過濾器都提供多種連接選項,可靈活滿足您特定的製程需求。
品質標準與文件
我們的過濾器由 Emprove® 計畫支援。計畫提供三種類型的檔案資料,以支援開發和製造作業的不同階段,例如資格驗證、風險評估和製程最佳化。這些檔案將特定產品的全面測試資料、品質聲明和法規資訊整合成一種易於使用的格式。
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