Table 3.
Light Obscuration Results.
Sample | ≥10 µm | ≥25 µm |
---|---|---|
mAb1 -80°C | 7 | 0 |
mAb1 5°C 12M | >1.80E4 | >1.8E4 |
mAb1 25°C 12M | >1.80E4 | >1.80E4 |
For measuring aggregates via light obscuration, a HIAC 9703+ instrument equipped with a 10 mL syringe was used to analyze mAb1 samples, according to the manufacturer’s instructions. Briefly, samples were pooled into a 50mL polypropylene sterile container and allowed to de-gas for 30 minutes. Environment test with water was conducted prior to sample testing to establish a particle free system. Five runs of one mL each were performed per sample. The first two runs were discarded, and the final three runs were averaged to yield the result. Per 100 mg.