Table 4.
Summary of size heterogeneity and aggregate profile assessed by SEC-MALS in thermal and mechanical stress conditions. (n = 3).
| Parameter evaluated | Molar mass moments (gm mol−1) |
|||||
|---|---|---|---|---|---|---|
| HMW | Intact mAb | |||||
| Bvz Brands | Avt | Bio-1 | Bio-2 | Avt | Bio-1 | Bio-2 |
| Control | nda | nd | nd | 1.497 × 105 (±2.598%) | 1.473 × 105 (±2.356%) | 1.464 × 105 (±2.127%) |
| 50 °C, 1 d | nd | nd | nd | 1.498 × 105 (±2.678%) | 1.474 × 105 (±2.387%) | 1.466 × 105 (±2.237%) |
| 50 °C, 7 d | 4.424 × 105 (±3.855%) | 4.570 × 105 (±4.163%) | 4.724 × 105 (±3.855%) | 1.464 × 105 (±2.066%) | 1.473 × 105 (±2.045%) | 1.495 × 105 (±2.855%) |
| 50 °C, 14 d | 9.484 × 105 (±2.490%) | 9.313 × 105 (±2.405%) | 9.853 × 105 (±2.450%) | 1.495 × 105 (±2.373%) | 1.507 × 105 (±2.166%) | 1.528 × 105 (±2.449%) |
| 200 rpm, 1 h | nd | nd | nd | 1.497 × 105 (±2.578%) | 1.473 × 105 (±2.436%) | 1.464 × 105 (±2.747%) |
| 200 rpm, 12 h | 2.952 × 105 (±2.807%) | 2.832 × 105 (±2.627%) | 2.982 × 105 (±2.627%) | 1.465 × 105 (±2.160%) | 1.479 × 105 (±2.531%) | 1.485 × 105 (±1.936%) |
| 200 rpm, 24 h | 7.415 × 105 (±2.309%) | 7.107 × 105 (±2.419%) | 7.726 × 105 (±2.229%) | 1.445 × 105 (±1.790%) | 1.465 × 105 (±2.443%) | 1.461 × 105 (±2.720%) |
nd; not detected.