Table 1.
Biochemical characteristics of recombinant PfCSP4/38 produced from L. lactis
Shown are the results obtained for recombinant PfCSP4/38 produced at both the 1- and 5-liter scale. Nonreducing (NR) and reducing (R) conditions are noted where tested.
| Test | Method | Specification | Result |
|
|---|---|---|---|---|
| 1 liters | 5 liters | |||
| pH | pH meter | Report (target 6–8) | 7.0 | 7.0 |
| Color and appearance | Visual observation | Clear, colorless solution free of particles | Clear, colorless solution free of particles | Clear, colorless solution free of particles |
| Endotoxin | LAL (Limulus amebocyte lysate) | ≤100 EU/mg | 8 EU/mg | 17 EU/mg |
| Protein content | BCA | >0.4 mg/ml | 0.5 mg/ml | 0.73 mg/ml |
| A280 | >0.4 mg/ml | 0.5 mg/ml | 0.9 mg/ml | |
| Identity and integrity | SDS-PAGE (NR/R) | Predominant band at expected molecular weight ≥85% | Major monomer band | Major monomer band |
| Western blot against mAb1A6, mAb1E8, and anti-histidine (NR/R) | Positive identification and predominant band at expected molecular weight | Major monomer band | Major monomer band | |
| Identity, integrity, and purity | SE-HPLC | ≥85% monomer | 96% monomer | 90% monomer |
| RP-HPLC | >85% | 94.9% | 93% | |
| Molecular mass | Intact mass spectroscopy via LC-MS/MS (NR/R) | Main peak ± 10 Da of expected mass | NR: 39624.8173 Da | NR: 39624.8161 Da |
| NR: 39,623 Da, R: 39,627 Da | R: 39628.8527 Da | R: 39628.8532 Da | ||