TABLE 1.
Component | Source | Source vol | Production | Time of harvest (hpia) | No. of 150-cm2 flasksb | Yield |
---|---|---|---|---|---|---|
Original MP-12 strainc | Plaque purified clone after 12th mutagenesis | NAd | MRC-5 cells, 1 passage at 37°C | 48–72 | NA | NA |
Master seed | Original MP-12 | 10−3 dilution, 1 ml/flask | MRC-5 cells, 1 passage at 37°C | 51 | 40 | >6.0 log10 PFU/ml (860 ml) |
Production seed | Master seed | 10−2.5 dilution, 1 ml/flask | MRC-5 cells, 1 passage at 37°C | 50 | 60 | >6.0 log10 PFU/ml (1,750 ml) |
Vaccine lot 7 | Production seed | 10−2 dilution, 1 ml/flask | MRC-5 cells, 1 passage at 35°C | 62 | 1,239 | 58,120 ml |
Vaccine lot 7-2-88 | Vaccine lot 7 | 5.5 liters | Filtration, 0.45-μm-pore-size filter | 5 log10 PFU/ml, 9,360 vials (5.5 ml) (freeze-dried) |
hpi, hours postinfection.
Fifty milliliters per flask.
The production of original MP-12 was described by Caplen et al. (6).
NA, data not available.