Millistak+HC AppGd_textC.qxd - Millipore

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to control cell density and contaminant levels. This raw cell culture is, similarly, clarified and sterile filtered to recover contained product. The suspended solids content of the raw cell culture is many times that of the prefiltered harvest fluid, as indicated by their relative turbidities (300 NTU versus 40 NTU). All tests were run at constant flow (150–200 L/m 2 /hr, based on prefilter area), with the clarifying prefilter and sterile filter operated in tandem. During the early growth phase of the culture with cell counts low, the 12 Sterile Filter Pressure Differential (psid) 16 14 12 10 8 6 4 2 prefilters displayed little or no pressure build-up: the capacity of the filter train was dictated by the pressure build-up on the downstream 0.45 µm filter. Figure 9 shows the pressure-volume profiles for the Millistak+ C0HC filter and two trial runs of the competitive product, using process-scale multilayer stacked-disk filter cartridges. The C0HC prefilters clearly demonstrated a capacity to retain not only the preclarified cell culture (harvest fluid) but also a relatively large portion of the untreated culture, in far greater volumes than the competitive product. Mammalian Cell Culture Perfusate Clarification C0HC: Preclarified Harvest C0HC: Unclarified Harvest Competitor: Harvest, Run 1 Competitor: Harvest, Run 2 0 0 50 100 150 200 250 300 350 400 Process Volume (L) Figure 9. Competitive Prefilter Analysis for Perfusion Bioreactor Product (Early) www.millipore.com
Tests run later in the perfusion cycle (when cell densities and contaminant levels are higher), showed significant pressure build-up on both prefilters and sterile filters for competitive products (see Figure 10). The Millistak+ C0HC filter repeatedly demonstrated far greater capacities for both preclarified and untreated biomass over competitive prefilter products. Whole Cell Culture A series of lab-scale tests were conducted on a CHO cell culture processed directly from a batch Capacity (L/m 2 ) 500 400 300 200 100 0 20 psid Competitor A Multilayer Biomass Cell Harvest 20 psid Competitor A High Capacity Single Layer 20 psid Competitor A Multilayer fermenter: the broth contained a cell density of 6 x 10 6 /mL, corresponding to 1.5% packed cell volume (cell viability 90%). The C0HC prefilter was applied in tandem with a 0.22 µm sterile filter (area ratio 6:1) at a constant prefilter flux of 160 LMH. The C0HC reached a capacity of 215 L/m 2 , on average, at a pressure differential of 20 psid: the sterile filter (which showed no significant pressure build-up) reached a corresponding capacity of 1100 L/m 2 . 20 psid B1HC C0HC C0HC C0HC Filter Type 4.5 psid 4.5 psid Figure 10. Competitive Prefilter Analysis for Perfusion Bioreactor Product (Late) 6.5 psid Millistak+ HC Filters Application Guide 13
Page 1: A P P L I C A T I O N G U I D E Â
Page 4 and 5: Figure 2. Millistak+ HC Stacked-Cel
Page 6 and 7: types present in the process stream
Page 8 and 9: Proven Performance for Mammalian Ce
Page 10 and 11: oths. For this particular case stud
Page 12 and 13: Post-TFF Microfiltration Mammalian
Page 16 and 17: Summary of Application Test Results
Page 18 and 19: Figure 11. Two Types of Behavior Ob
Page 20 and 21: Figure 13. Effect of Flux on Capaci
Page 22 and 23: Guidelines for Process-Scale Operat
Page 24 and 25: A larger air flow may indicate a le
Page 26 and 27: Manual Procedure The configuration
Page 28: Hot Water Sanitization In some proc

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