TABLE 1.
Properties of different feed streams used in this study.
Feed stream | Physicochemical properties of particulate matter |
Pichia pastoris cell broth for HSA production | NTU 3500, mean particle size 4–6 μm w/w |
Pichia pastoris cell broth centrate | NTU 300, mean particle size < 100 nm, unstable, becomes hazy in 12–15 h |
CHO cell culture harvest | NTU 1785, cell viability 85% |
CHO cell culture centrate | NTU 200–400, unstable, becomes hazy in 12–15 h |
Refolding output of GCSF (quenched) | NTU 1600, white precipitate due to HCP while quenching from 9.5–4 using acetic acid, 50–100 nm size |
Drug product GCSF | Clear solution |
Drug product mAb | Clear solution |