The regulatory agency expects that the acceptance criteria are fulfilled for every stability sample and the current regulatory guidance then recommends the expiration date, which is applied to future manufactured lots produced with the same manufacturing process.
Similar data were obtained for all 3 reproducibility runs, showing consistency among the three lots produced (data not shown).
Therefore, vaccine batches produced from this lot are at the same passage level as other lots produced later, providing the necessary production standardization.
In addition, we used two different seed lots to represent the initial inbreds F252 and MBS: S2 seeds from the initial seed lots produced in the nursery in 2003, and commercial seeds.
This produced a good fit to data (R = 0.88) and therefore the model could predict the germination of seed lots produced and incubated at different temperatures in the lab not used to train the data.
However, across the 20 seed lots produced for the main study, there was not a significant relationship between DR p50 and DAA (graph not shown), nor between relative improvement in longevity with the BD treatment and DAA (Fig. 3D).
Because all vaccine lots produced in India must be released by the National Control Laboratory (ie, Central Drugs Laboratory [CDL], Kasauli, India), its representatives along with SIIL quality control personnel traveled to Potters Bar, United Kingdom, for training at NIBSC.
In this study, we determined that the mean titer of samples obtained during 2003 2008 from persons with a confirmed diagnosis of WNV infection was 100× higher than the mean titers of IGIV lots produced in 2008.
We also assumed that no further contaminated lots were produced after production of lot 08.
These methods are typically studied for the quality control problem to accept or reject a lot of produced items.
