LV Process Analytics Services

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. BIA Separations, Inc. 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

Browse the Library Explore Solutions for EV Discover Analytical Solutions

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

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 LV 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 LV samples?

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 support@biaseparationsinc.com

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