Table 3 ProC6C cGMP proposed release assays.
From: Preclinical development of a Pfs230-Pfs48/45 chimeric malaria transmission-blocking vaccine
Attribute | Test | Analytical test method | Proposed specifications |
|---|---|---|---|
Biochemical | Appearance | Visual assessment USP<1790> | Clear, colorless solution free of particles |
Biochemical | pH | Potentiometric pH USP<791> | 7,5–8,5 |
Biochemical | Total Protein Concentration | SE-HPLC | ≥0.4 mg/ml |
Biochemical | Endotoxin | LAL | ≤100 EU/mg |
Identity | Protein ID | Western blot | Positive identification and predominant band at expected molecular weight |
Identity/purity | ProC6C full-length MW | SDS-PAGE | Predominant band at expected molecular weight ≥85% |
Identity/purity | ProC6C full-length | SE-HPLC | ≥85% monomer |
Potency | Biological Activity | ELISA Folding | ≥85% |
Residual/purity | Residual DNA | Quant-it | 10 pg/µL to 100 ng/µL |
Residual/purity | Host cell protein | L. lactis WB | <1% w/w |
Residual/purity | Boron/borate | ICP-AES | TBD |
Safety | Pyrogen | Rabbit pyrogen testing USP<151> | USP<151> |
Safety/purity | Microbial enumeration | Bioburden USP<61> | USP<61> |
