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The uncertainty in the safety of empty capsids has drawn the focused attention of FDA and experts. As an innovative drug, it is also expected by regulatory trends to minimize the number of empty shell particles lacking the target gene, viral vector particles containing fragmented or partial genomes through production system optimization in order to obtain as many high-quality viral vector particles containing the complete genome as possible by purification. Creative Biogene's optimized process combined with advanced quality control methods for emptying rates ensure that we can provide our clients with high-quality viral vectors.
During the manufacture of adeno-associated viral vectors (AAV vectors), unwanted, incomplete particles are co-produced. They lack the recombinant viral genome and consist only of empty capsid proteins. Empty capsids increase the required dose of AAV virus for medical use and are thought to cause an immune response against the vector capsid, leading to unwanted side effects. Therefore, the ability to remove the empty capsid during manufacturing and to quantify the amount of empty AAV particles in the formulation is a key requirement for any AAV production process.
Creative Biogene has developed a series of methods suitable for process development support and characterization as QC-friendly options for GMP release testing at all stages of viral vector development.
| Method | Description |
| Analytical Ultra Centrifugation (AUC) | Capable of accurately quantifying simultaneously empty coat, partial coat and full coat material, as well as aggregates and other impurities. The technique is applicable to many different serotypes, several sizes of transgenes and different production processes. |
| Transmission Electron Microscope | Direct tool for measuring the relative number of AAV empty shells. Contrast is increased by the heavy metal stain uranyl formate. After negative staining and observation by transmission electron microscopy, empty-shell virus particles are easily distinguished from solid virus particles containing the genome. |
| Anion-Exchange Chromatography (AEC) | Based on the difference in isoelectric point between different capsid virus particles to detect samples, it is suitable for the separation and detection of empty capsid particles and intact capsid particles of several serotypes. Currently, we have successfully isolated empty coat particles and solid particles of several serotypes including AAV1, AAV2, AAV5, AAV6, AAV8 and AAV9 using this method. |
| Optical Density Method | Based on pre-determined extinction coefficients for coat protein serotypes and genomes, it quantifies coat protein titers and AAV vector content ratios by measuring nucleic acid and protein absorption at 260 nm and 280 nm. |
Creative Biogene offers a wide range of analytical methods for characterizing shell rates and provides an optimized combination of technologies to ensure safer and higher quality AAV vector products for our customers to better meet clinical trial and commercialization demands. 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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