Adenovirus vectors (AdV) are commonly used in gene therapy applications and vaccine development. For efficient process development and ensuring consistent product quality, well-defined and reliable analytical methods are needed. Key challenges in AdV analytics are accurate quantification of functional particles and detection of common impurities, such as host cell DNA and proteins.
Common Challenges in AdV Analytics
- Characterisation: Accurate quantification of viral particles is essential in phase of process development and optimization, as well as for quality control in established production processes.
- Impurity Profile: Reduction of host cell impurities in the purification process is essential for safety of final drug preparation.
- Functionality: Target AdV product needs to efficiently transfer a new function into target cells.
With Cornerstone services, these common challenges in LV testing are addressed while providing a solution tailored to your specific needs. Sartorius BIA Separations experts provide comprehensive support in these areas, ensuring optimal analytical method development and sample evaluation.
Overcoming AdV Analytical Challenges
Combination of different analytical methods, including PCR, chromatographic analysis and cell-based assays, provides an overview of sample composition and allows for efficient process optimization towards high purity and yields.
- Comprehensive Analytical Toolset
AdV can be quantified by dPCR method for detection of viral nucleic acid and semi-quantified using PATfix analytical chromatography. - Integration of Analytical Data
Besides detection of target AdV, PATfix Adeno method enables evaluation of host cell impurities in the same chromatographic analysis. Additional assays for determination of total protein and total DNA concentration are also used. - Cell-Based Assay
Infectivity assay on a selected cell line allows assessment of functional AdV particle delivery into cells.
Why Choose Cornerstone AdV Process Analytics Services?
By partnering with Cornerstone AdV Process Analytics Services, the following benefits are offered:
- Established analytical toolbox for multiparametric sample evaluation.
- Analysis of target AdV and impurity profiles.
- Skilled team of scientist with broad experience in the gene therapy and vaccine field.
Additional Resources
Read the poster A PATfix® Analytical Method for Adenovirus Sample Characterization in Upstream Process Development for more detailed insights
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FAQ About Services for AdV Process Analytics
The facilities are located in Ajdovščina, Slovenia. Support for process development is available in modern, fully equipped BSL 1 and 2 facilities. A virtual tour of the laboratories is available.
For analytical testing of AdV, we offer PATfix analytical chromatographic method, dPCR and cell-based assay. Further insights into impurity profile can be provided by testing of host-cell protein and DNA. Method development and validation are available for all these services.
The multi-wavelength UV-Vis detector, fluorescence detector, and multi-angle light scattering (MALS) detector monitoring nine angles are used. By using different detectors, detailed sample information is obtained in one analytical run.
Consult Our Experts
Our experts would be happy to discuss your project. Fill the contact form below or send us an email to cornerstone@biaseparations.com
