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A variety of foreign impurities are generated during the viral vector manufacturing process, and these impurities can affect the safety and efficacy of the final product. Creative Biogene has developed a series of well-developed quality control strategies for the production of GMP viral vectors to effectively identify, quantify, characterize and control impurities to ensure the delivery of high-quality viral vector products to our customers.
Impurities during viral vector production generally include host cell DNA size distribution and residues, host cell protein residues, plasmid DNA residues, nuclease residues, specific process-related residues (e.g., affinity ligands, BSA), and decontaminant residues. For host cell DNA residues, differences in residue levels inside and outside the capsid are also of concern. Impurity testing is an important step in ensuring the safety and efficacy of GMP viral vector production. It helps to identify and quantify any potential contaminants or impurities, allowing us to take corrective action during the manufacturing process and ensure that the final product meets the desired quality specifications.
The complexity of the viral vector production process leads to a diversity of process impurities. Creative Biogene has developed a comprehensive testing protocol for impurity detection as a quality attribute, covering all impurities that may be present during the production of viral vectors and meeting the relevant quality control regulatory requirements. The application of different analytical methods has driven the optimization of the process and ensured the safety and efficacy of the viral vectors.
| Impurity to be Detected | Method |
| Host protein residues | ELISA, LC-MS, 2D-SDS-PAGE |
| Host DNA residues | qPCR, ddPCR |
| Nuclease residues | ELISA |
| Plasmid DNA residues | qPCR, ddPCR |
| Specific process-related residues (e.g., affinity ligand ELISA, HPLC ELSD, HPLC CAD, HPLC BSA, PEI, decontaminant, helper virus) | MS |
As a CDMO company focused on viral vector production, Creative Biogene offers a comprehensive impurity detection solution. Our reliable assay technology ensures accurate results and guarantees high-quality and purity viral vectors for our customers. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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