Considerations for Scaling-up Depth Filtration of Harvested Cell Culture Fluid - Data on the performance and variability of different formats. - BioPharm International

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Considerations for Scaling-up Depth Filtration of Harvested Cell Culture Fluid
Data on the performance and variability of different formats.


BioPharm International
Volume 22, Issue 3

Filter Capacity


Figure 8. Depth filter capacities at 0.15 psi/LMH resistance versus format and scale
Filter capacity was assessed for each test by determining the L/m2 loading when the depth-filter resistance reached 0.15 psid/LMH (~15 psid). As shown in Figure 8, the depth-filter capacities were comparable and repeatable at about 400 L/m2 for all filter types with the exception of the Mini filters, which consistently showed 25% higher capacities of 500 L/m2. If the Mini filters are excluded, there is no statistical difference in capacity between the remaining devices. The Mini filter has more variability than the other devices.

Filtrate Quality


Figure 9. Depth filter filtrate turbidities at 0.15 psi/LMH resistance quality versus format and size
Figure 9 shows that the turbidities were comparable and repeatable at about 5 NTU with the exception of the Mini filters, which showed 15% lower turbidities at 4.25 NTU. The magnitude of the difference was small (<1 NTU) and its result on the downstream sterile filter capacity appears to have been negligible. It is likely this difference is because of the fluid composition averaging that occurs in slowly filling the vial for turbidity measurement using a Mini filter as opposed to somewhat instantaneous filling using larger sizes. Some effects could also be because of real differences in the devices or in measuring equipment or operator procedures. The 25% higher capacity of the Mini filters cannot be attributed to nonintegral devices by turbidity measurement.

Sources of Variability


Table 3. Sources of capacity variability
Batch-to-batch variability in capacity at the manufacturing scale includes variability in the HCCF centrate feed, filter lot, and operation. For this study, we minimized variability in the HCCF centrate, limiting it to hold-time differences and labeled here as sequence. We restricted filter variability to different formats, sizes, and the variability within a single lot of filter media labeled as device. Variability in operation was limited to test location. The capacity data was analyzed by ANOVA using Minitab software. The sources of variability are summarized in Table 3.


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