Lentiviral vectors (LV) are already well established in the development of CAR-T therapies for ex vivo use and have recently started gaining attention also for in vivo applications. These will require even better-defined quality parameters and the ability to precisely follow them throughout the production process. The key challenge in Lentivirus analytics remains the large heterogeneity of samples, with different populations of incomplete LV particles that can impact final product safety and efficacy.
Common Challenges in LV Analytics
- Complexity of LV: Only a small fraction of particles in LV harvest represents complete virus that has the ability to transduce target cells.
- Sample Stability: LVs are especially prone to loss of integrity due to freeze-thaw cycles, shear stress, pH and temperature changes, which can introduce additional variability in analytical results.
- Interferences and Specificity: Upstream harvests have a myriad of components, including extracellular vesicles, which can overlap in characteristics to target LVs.
With Cornerstone services, these common challenges in LV testing are addressed while providing a solution tailored to specific needs. Sartorius BIA Separations experts provide comprehensive support in these areas, ensuring optimal analytical method development and sample evaluation.
Overcoming LV Analytical Challenges
Integration of different analytical methods provides an overview of sample composition and allows for efficient process optimization towards high purity and yields.
- Broad Analytical Toolset
LV can be quantified based on infectivity assays on HEK293T or Jurkat cells, dPCR for determination of physical titer, ELISA test and Videodrop particle analysis. - Handling and Storage
Based on experience and internal data on LV stability, special attention is taken to ensure consistency in sample handling and storage between experiments. - Integration of Analytical Data
Additional methods based on PATfix and plate assays offer insights into sample impurity profiles for detection of host-cell protein and host-cell DNA.
Why Choose Cornerstone LV Process Analytics Services?
By partnering with Cornerstone LV Process Analytics Services, the following benefits are offered:
- Established analytical toolbox for multiparametric sample evaluation.
- Analysis of target LV and impurity profiles.
- Skilled team of scientist with broad experience in the gene therapy field.
Additional Resources
Read the poster Lentiviral Downstream Process Optimisation and Design of Experiments on CIM QA 0.05 mL Monolithic 96-Well Plates for more detailed insights
Hear From Our Customers
Ready to Discuss Your Project?
FAQ About Services for LV 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 LV we offer dPCR method, Videodrop particle analysis and cell-based assays on HEK293T and Jurat cell lines. Further insights into impurity profile, including host-cell protein and DNA, can be provided. Method development and validation are available for all these services.
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
