细胞培养基过滤器

Section Overview
无菌过滤用于保护上游细胞培养操作免受污染。无论您需要降低细菌或支原体污染的风险,我们的密理博快®、非PFAS细胞培养基过滤器都能为您提供去除微生物的选择,同时实现最佳的细胞生长和生产率,并提供您所需的过滤容量和吞吐性能,以实现工艺经济性。
在选择过滤器之前,我们建议您进行风险分析,以确定您所需的生物负载控制水平--灭菌过滤器或同时去除支原体的灭菌过滤器。此外,我们的过滤产品组合还得到了 Emprove® 计划的支持,该计划可为您提供简化风险评估和合规性所需的文件。
如需帮助确定适合您工艺的过滤器,请联系我们。
STERILIZING CELL CULTURE MEDIA FILTERS
Millipore Express?sup>® SHC(无菌、高容量)过滤器具有极高的过滤能力,可用于堵塞细胞培养基。集成的 0.5 µm 聚醚砜(PES)膜预滤器可保护 0.2 µm PES 灭菌膜,从而最大限度地提高过滤容量并增强过滤的稳健性。
- Millipore Express® SHC 过滤器具有高渗透性,易于润湿和完整性测试,并具有广泛的化学兼容性。
用于细胞培养基的支原体去除滤器
Millipore Express® SHR 过滤器(无菌,高截留)提供≥ 7.0 log 的支原体去除率和灭菌级性能,适用于需要额外安全级别的上游工艺。0.1 µm 的支原体截留 PES 膜具有高渗透性和出色的微生物截留能力。
如需更多堵塞细胞培养基,请访问我们的 Millipore Express® SHRP过滤器包含一个集成的0.5 µm PES 预滤器,可保护 0.1 µm 支原体截留膜,提高过滤能力和工艺稳定性。
Formats FROM BENCH TO PRODUCTION SCALES
我们的细胞培养基过滤器提供:
- OptiScale®格式可实现高效筛选和放大,筒式和胶囊格式在生产过程中经过 100% 的完整性测试。
- 高面积胶囊和滤芯格式可在不增加占地面积的情况下最大限度地提高过滤效率。
- 可高温高压灭菌、预灭菌或伽马射线兼容的格式,可集成到 Mobius® 一次性组件中。有关每个产品系列的完整信息和准确过滤面积,请参阅产品说明书。请阅读我们的技术文章,了解有关不同过滤器格式的更多信息。
Products
质量标准和文档
所有密理博快滤®
所有Millipore Express® SHC、Millipore Express® SHR和Millipore Express® SHRP过滤器都支持 "质量证书"。SHRP 过滤器由 Emprove® 计划提供三种类型的档案资料,以支持不同阶段的开发和生产操作,如鉴定、风险评估和工艺优化。这些档案资料以随时可用的格式整合了全面的产品特定测试数据、质量声明和监管信息,使您能够满怀信心地向前迈进。
相关资源
- Article: Optimizing Upstream Processing: Media Filtration and Cell Culture Performance
This technical article provides guidance on selecting and sizing filters for cell culture media filtration.
- App Note: Cell Culture Media Filtration. Selection and Sizing Filters for CHO Cell Culture Processes
Explore throughput performance of Millipore Express® aseptic filters for cell culture media filtration and their impact on filter sizing.
- App Note: Cell Culture Media Filtration. Evaluating Performance of CHO Cell Cultures
Learn how to check if your media filter impacts performance. Studies confirmed PES and PVDF membrane filters did not affect cell growth and viability.
- Tech Note: Performance of High-Area Millipore Express® Cartridge Filters
High area filters can improve filtration productivity for mid- to high- plugging streams. Read how our model can help predict the benefits for different streams.
- Tech Note: Mycoplasma clearance by Millipore Express® SHR filters at pilot and production scales
Retention studies demonstrate 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.
- App Note: Cell Culture Media Mixing and Microfiltration: Reducing Risk with Single-use Technology
This app note explains considerations for the preparation of cell culture media and focuses on the benefits of mixing and filtration using single use technologies.
- Millipore Express® Family Guide
Read this guide to review key differentiators and product specifications of Millipore Express® membrane filters.
- Tech Note: Integrity Test Troubleshooting - Beyond Rewet and Retest
Filter integrity testing doesn’t always go smoothly. Learn how to avoid costly mistakes and troubleshoot integrity test challenges.
- Brochure: Vmax™ Constant Pressure Test for sizing Aseptic Filters
This protocol describes how to use results from small scale studies to predict filtration area requirements.
- Tech Article: Aseptic Filter Formats: Selection Guide
相关网络研讨会
为生物制造选择无菌过滤器取决于具体的加工需求。了解如何为您的工艺选择最佳过滤器。
变更管理通常被认为很复杂。了解如何使用基于风险的方法来加快批准后的产品变更。
本网络研讨会解释了失控生物负载的影响、生物负载源和降低风险的策略。将风险降到最低可减少故障和调查。
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