AdV Process Analytics Services

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. BIA Separations, Inc. 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

Browse the Library Discover Analytical Solutions

Read the poster A PATfix® Analytical Method for Adenovirus Sample Characterization in Upstream Process Development for more detailed insights

Hear From Our Customers

The PATfix pDNA analytical platform package was helpful in getting the plasmid analysis running with validated protocols built-in the system. We have also been utilising PATfix for the analysis of IVT mRNA with validated protocols provided by BIA Separations, Inc.. We have been getting consistent and reliable results with high-throughput work processes made possible by the at-line implementation of the PATfix platform. I am happy with the system as it is easy to use, reliable and the support provided by the highly knowledgeable team at BIA Separations, Inc. and Sartorius has been excellent. I am looking forward to continuing working with the PATfix platform and the BIA Separations, Inc. team with their ongoing developments in providing high-quality analytical products. – Dae Jong Han, Research Specialist (Analytics), BASE mRNA Facility, Australia.

“By leveraging the capabilities of PATfix, I can effectively determine the ratio of empty and full capsids in our samples, thus providing valuable insights into their purity values. The software’s integration functions are designed with user-friendliness in mind, making the analysis process seamless and efficient.” – Tony Tavares, PhD | Principal Scientist. Teknova

BioNet

“We are very pleased to be collaborating with BIA Separations / Sartorius in developing and tech-transferring optimized mRNA vaccine manufacturing processes. When time is of the essence, it is crucial to be able to rely on key partners whilst maintaining the highest level of quality in every aspect of our work. We are also very proud that our team was able to produce two kinds of genetic vaccines (DNA and mRNA) and we look forward to expanding our partnership with the BIA Separations’ team on future projects.” – Hong Thai Pham, CEO, BioNet

Pharmaron

Working with BIA Separations, Inc., Pharmaron was able to extend its toolbox of AAV purification solutions, providing multiple-modality options to achieve robust separation of genome-containing (full) from genome-free (empty) viral capsids with high purity and yield for multiple AAV serotypes. During this collaboration, a strong partnership was developed leading to Sartorius BIA separations presenting the work at the second webinar of the Pharmaron Cell and Gene Therapy webinar series. The webinar was entitled “Downstream AAV Production: A Targeted Approach to Optimization”.

Theriva Biologics

“I highly appreciated the willingness of each expert from different monoliths and various applications to support our work, explain new methods, introduce new approaches, and offer further technical support in our product development. I feel like I can really delve into the depths of product characterization, and I believe I can gain much more data from the PATfix system, which I’m really eager to explore in the future.” – Sonia Celej, Bioprocess Development Specialist, Theriva Biologics

FAQ About Services for AdV Process Analytics

Where are the facilities located?

The facilities are located in Wilmington, Slovenia. Support for process development is available in modern, fully equipped BSL 1 and 2 facilities. A virtual tour of the laboratories is available.

What analytical solutions are offered for AdV samples?

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.

What type of detectors are used for chromatographic AdV analysis?

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 support@biaseparationsinc.com

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