Our comprehensive service platform is supported by a highly skilled GMP quality control team with extensive expertise in method development, qualification/validation, and compliance testing, ensuring consistent product quality throughout the entire lifecycle. The table below presents the key release testing parameters.
| Category | Quality Attibutes | Analytical Method |
| Identity | Identity | WB, SDS-PAGE |
| Molecular weight | SDS-PAGE | |
| Isoelectric point | Isoelectric focusing (IEF) | |
| Quantification | Protein concentration | BCA, UV |
| Potency | Biological activity | In vitro bioassay |
| Specific activity | Biological activity:Protein concentration | |
| Purity | Purity | SDS-PAGE, CE-SDS, HPLC |
| Impurities | Process-related residuals | ELISA, HPLC |
| Residual Sf9 host cell DNA | qPCR | |
| Residual baculovirus DNA | qPCR | |
| Residual Sf9 host cell proteins | ELISA | |
| Residual baculovirus proteins | ELISA | |
| Residual rhabdovirus contaminants | qPCR | |
| Safety | Endotoxin | Gel clot assay, photometric assay |
| Sterility | Cell culture | |
| Spiroplasma | qPCR | |
| Mycoplasma | Cell culture, qPCR | |
| Abnormal toxicity | Injection in mice/guinea pigs | |
| Other Physicochemical Properties | Appearance | Visual inspection |
| Visible particles | Optical inspection | |
| pH | Potentiometry | |
| ... | ... |
US: 3675 Market Street, Suite 200, Philadelphia, PA19104 Tel: +1 (215) 205-6963 | +086 027-65023363
E-mail: hui.wang@genevoyager.com
China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com
US: 3675 Market Street, Suite 200, Philadelphia, PA19104 Tel: +1 (215) 205-6963 | +086 027-65023363
E-mail: hui.wang@genevoyager.com
China: No128, Guanggu 7th Rd, East Lake High-tech Development Zone, Wuhan, China Tel: 17720522078
E-mail: marketing@genevoyager.com
