Physicochemical characterization of stressed mAb materials.

Abstract

<p>Representative MFI screenshots after freeze/thaw (FT) stress of mAb1 (A) unstressed, un; (B) stress level 1, sl1; (C) stress level 2, sl2 and mAb2 un, (E) sl1 and (F) sl2. (G) Particle Size distribution obtained by MFI of mAb1 (left) and mAb2 (right). For visualization the size binning 2–2.5, 2.5–5, 5–10 10–25, 25–50 and 50–400 µm was used. Representative images of individual particles formed by (H) heat/shake, HS; (I) freeze/thaw, FT and (J) shear stress, S. Polydispersity in % (PD%) revealed by DLS for (K) mAb1 and (L) mAb2.</p