Table 2.
Run | TFF1 | IEX | TFF2 device type | TFF2 & sterile filtration, by qPCR | Sterile filtration, by spectrophotometry | |
---|---|---|---|---|---|---|
ChAdOx2 RabG | 1 | 85 | 44 | Pellicon 2 Mini | 53 | 98 |
2 | 79 | 72 | Pellicon 2 Mini | 94 | 96 | |
3 | 113 | 65 | MidiKros | 119 | 93 | |
ChAd63 ME-TRAP | 1 | 80 | 100 | Pellicon 2 Mini | 59 | 100 |
2 | Not done | 48 | Pellicon XL50 | 39 | 48 | |
ChAdOx1 RVF | 1 | 101 | 39 | MidiKros | 77 | 76 |
2 | 107 | 36 | MidiKros | 54 | 90 | |
OVERALL | 93 (79–113) | 48 (36–100) | Pellicon 2 Mini | 59 (53–94) | 98 (96–100) | |
MidiKros | 77 (54–119) | 90 (76–93) |
Percentage product recovery at each step was calculated for consecutive individual runs with each virus. All calculations were based upon viral genome qPCR, with the exception of recovery after sterile filtration which is based upon spectrophotometry (as there is no change in buffer composition at this point).
qPCR-based results are the means of results obtained from three replicate samples, with three replicate qPCR reactions per sample. All calculations were based upon comparisons made within a single qPCR run. Apparent recoveries in excess of 100% reflect residual qPCR assay variability.
The qPCR-based results presented for TFF2 recovery were produced by comparing samples taken prior to TFF2 and from the final product (after TFF2 and sterile filtration), on the basis that product loss upon sterile filtration typically reflects aggregation as a result of poor performance of the TFF2 process. Summary results are presented as medians with ranges in brackets, and are broken down by device type for TFF2 (excluding the single run performed using a Pellicon XL50 unit).