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.
Read moreEV Process Analytics Services
Interest in stem-cell and engineered cell derived extracellular vesicles (EV) as novel therapeutic modalities has been growing in recent years. With progression of candidate drugs through the clinical trial stages it is essential to establish reliable analytical methods for detailed characterization of EV samples. One of the key challenges in EV analytics is their complexity, with multiple particulate species present in the samples.
Common Challenges in EV Analytics
- Matrix Effects: Common cell culture media components can overlap in size and characteristics to EVs and hinder their accurate detection.
- Sensitivity and Sample Quantity: Sample availability can be limited, especially in case of stem-cell derived EVs, due to high cost of goods and low concentrations obtained in traditional production systems.
- Low Specificity: Traditional methods that rely solely on particle concentration measurements do not offer sufficient information about sample composition and target EV content.
- Particle Heterogeneity: Different types of particles are present in conditioned media samples, which makes target EV quantities difficult to evaluate.
With Cornerstone services, these common challenges in EV 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.
Contact UsOvercoming EV Analytical Challenges
Combination of PATfix SEC and PATfix AEX analytical methods allow insights into EV sample composition, for better particle subpopulation analyses and identification of sample impurities. Complex samples can be further screened using 2D chromatography approach PATfix VS that benefits from best aspects of both SEC and AEX analytical methods.
- Detailed Evaluation
PATfix SEC method provides comprehensive EV profile, including impurities, particle sizing and relative quantification. - Low Sample Consumption
MALS, UV and fluorescence detectors used in chromatographic methods allow sensitive detection of biomolecules. - Detection of EV Surface Markers
PATfix SEC method offers specific detection by utilization of immuno-labeling for EV-related surface markers, which is routinely in use for CD63, CD81 and CD9 tetraspanins. Method can be further developed and optimized for any surface marker of choice.
- Orthogonal Methods
Additional analyses including nanoparticle flow cytometry, nanoparticle tracking analysis (NTA) and western blot can be performed for detailed sample characterization.
Why Choose Cornerstone EV Process Analytics Services?
By partnering with Cornerstone EV Process Analytics Services, the following benefits are offered:
- Analysis of target EV and impurity profiles in one method.
- Low sample consumption.
- Comprehensive sample evaluation including novel analytical methods.
- Detection of particle subpopulations based on surface markers.
Additional Resources
Read these assets for a more detailed insight:
Read these assets for a more detailed insight:
Hear From Our Customers
Ready to Discuss Your Project?
FAQ About Services for EV Process Analytics
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.
For analytical testing of EV we offer PATfix analytical chromatographic methods that can detect different surface markers, while also providing insights into impurity profile of sample. Additional analyses using particle flow cytometry and NTA can be performed. Method development and validation for your specific application are available.
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