The development of gene and cell therapy products and the CDMOs are very important to the R&D of innovative drugs. Based on years of experience in viral vector preparation and quality control, Hengyu biotech provides clients with a full range of vector characterization and process residue detection services as reliable quality assurance for quick IND applications and BLA large-scale production in the future for gene and cell therapy products.
AAV Viral Vector Characterization
Quality Control of Gene and Cell Therapy Products
AAV Viral Vector Characterization
The viral vectors are important gene transfer tools in gene and cell therapy products, and the necessity of their quality control is self-evident. Hengyu biotech provides clients with high-quality and reliable quality testing services in terms of viral vector characterization based on "CAR-T Cell-based Therapy Product Quality Control Testing Research and Non-Clinical Research Considerations", "Technology Guidelines for Cell-based Therapy Product Research and Evaluation", "Technology Guidelines for Pharmaceutical Research and Evaluation of Gene-based Therapy Products (Draft for Comments)", and other appropriate regulations. Hengyu biotech provides specific services based on the characteristics of different vectors, for example, serotyping and empty grain rate analysis of adeno-associated virus (AAV) vector, and reverse mutation analysis of oncolytic virus.
Assay items
- Sterility inspection
- Endotoxin detection
- Empty grain rate analysis
- Physical titer determination
- Particle titer determination