At-line Analytical Solutions
Innovative Analytics for Gene Therapy and Vaccines
In gene therapy and vaccine products, ensuring purity during downstream processing is especially challenging. Fast and efficient tracking of target biomolecules and removal of impurities is critical, because it directly affects product yield and purity. Sartorius‘ analytical chromatography column solutions can help provide this information in real-time, through at-line monitoring of large biomolecules including viruses, pDNA, and mRNA.
IVT reactions are efficient for mRNA production, and new analytical tools can help you achieve high recovery and quality.
Move away from traditional, labor-intensive methods including ddPCR, ELISA, and TCID50
Currently two methods are needed to determine both E/F AAV capsids. Analytical chromatography provides one technology instead of two
Get direct insight into samples with at-line analytical solutions
HPLC monitoring and quantitation of large biomolecules delivering rapid, high-resolution separations in minutes.
A unique automated platform for real-time tracking of viral particles and quantification of total intact particles.
Using CIMac™ analytical columns, the PATfix® HPLC system gives at-line analysis for the control of impurities and critical quality components using HPLC fingerprinting.
CIMac™ Analytical Columns combine all the characteristics of CIM® monoliths at analytical scale. They are a perfect tool for analysis and control of manufacturing processes, and ideal for process analytical technology (PAT).
Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, these columns can be operated at high volumetric flow rates – from one to ten column volumes per minute – allow high-resolution separations with quantity and purity information delivered in minutes.
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Featuring bio-inert ceramic pump heads and flow rates up to 10 mL per minute, PATfix® is designed to manage the analytical parameters for a wide range of biological products. A highly sensitive, multi-wavelength UV detector as well as a fluorescence detector, captures component peaks, even with the steepest gradients.
PATfix® is powered by PATfix® software, a comprehensive, user-friendly toolbox for automated analysis of chromatographic data sets. PATfix® software provides rapid feedback to help you make critical process control decisions.
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IEX
HIC
Mixed-Mode
Affinity
CIMac™ AAV Full/Empty
CIMac™ OH
CIMac™ H-bond ADC
CIMac™ OligoDT18
CIMac™ Plasmid DNA
CIMac™ C4 HLD (mRNA, pDNA)
CIMac™ PrimaS (mRNA)
CIMac™ Adeno
CIMac™ C4 A
CIMac™ QA
CIMac™ DEAE
CIMac™ COOH
CIMac™ HDZ-Affinity
CIMac™ SO3
CIMac™ EDA-AEX/Activated
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AAV
Adenovirus
mRNA
pDNA
Other Large Biomolecules
Proteins
CIMac™ IDA
CIMac™ C4 HLD
CIMac™ r-Protein A
CIMac™ r-Protein L
CIMac™ r-Protein G
Sartorius experts represent extensive experience in chromatography and purification of biomolecules as well as analytical methods development.
Sartorius‘ virus quantification products offer a new approach to enable direct, biologically-specific quantification of viruses in minutes, rather than the days or weeks. Virus samples are labeled with specifically-developed reagents in a no-wash assay. The purpose-built platform enables quantification of total virus particles in three minutes per sample, giving users real-time insights into viral titers.
Virus Counter® platform rapidly and precisely quantifies total virus particles:
Explore Virus Counter®
Sartorius’ facilities are fully equipped to develop process and analytical methods for biomolecules up to biosafety level 2.
Increase control, improve efficiency and prevent rejection of batches in both upstream and downstream with in-process controls (PAT).
Enable real-time product release through final control methods.
Use methods that can be validated. Sartorius’ HPLC methods use CIMac™ Analytical Monoliths and are developed on PATfix® along with reference methods for characterization.
Includes method development, validation and verification, transfer and routine testing of pharmaceutical samples and biomolecules.
Unlock new insights to streamline mRNA process development, product quantification, and sample characterization.
Our application note reveals how to quickly implement innovative tools for developing and maintaining robust pDNA production processes.
See how Sartorius services help support maintenance and longevity of your Research & Biomanufacturing Equipment while ensuring minimal downtime.
IVT reactions can now produce mRNA reaching 12g/L, and our data show Hydrosart TFF cassette and Sartopore 2 offer high recovery and quality.
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