Biomolecule Analysis Tools
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.
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
At-Line HPLC
At-Line HPLC Analytical Chromatography Using CIM® Monolith Technology
Using CIMac analytical columns, the PATfix® HPLC system gives at-line analysis for the control of impurities and critical quality components using HPLC fingerprinting.
Upstream AAV Analytics
PATfix® AAV Switcher Platform
A chromatography-based analytical platform that simplifies AAV quality monitoring with a 2-step process – capture and separation – to accurately measure viral quality from the complex upstream samples.
Downstream AAV Analytics
PATfix® AAV Platform
An at-line chromatography-based analytical system that accelerates downstream process development by rapidly measuring impurities, capsid recovery, and empty/full ratios to ensure viral vector quality and regulatory compliance
CIMac Analytical Columns
CIMac Analytical Columns bring the unique convective‑flow performance of CIM® monoliths to the analytical scale, making them ideal for in‑process analysis and control in manufacturing and other process analytical technology (PAT) workflows.
Designed for fast, reproducible chromatographic monitoring and quantification of proteins, viruses, nucleic acids, and other large biomolecules, they deliver rapid, high‑resolution separations in minutes with consistent performance across a wide range of flow rates.
PATfix® LNP Switcher Platform
A chromatography-based analytical platform tailored for lipid nanoparticle (LNP) characterization, enabling at-line determination of encapsulation efficiency, particle size, and lipid composition to accelerate nucleic acid–based therapeutic development.
PATfix® - mRNA Platform
PATfix® mRNA Platform: A chromatography-based analytical platform tailored for mRNA characterization, enabling at-line IVT reaction monitoring, rapid quantification, and comprehensive quality control (size, integrity, dsRNA) to accelerate nucleic acid therapeutic development.
CIMac Analytical Columns
CIMac Analytical Columns bring the unique convective‑flow performance of CIM® monoliths to the analytical scale, making them ideal for in‑process analysis and control in manufacturing and other process analytical technology (PAT) workflows.
Designed for fast, reproducible chromatographic monitoring and quantification of proteins, viruses, nucleic acids, and other large biomolecules, they deliver rapid, high‑resolution separations in minutes with consistent performance across a wide range of flow rates.
Monolithic Analytical Columns by Chemistry and Application
| IEX | HIC | Affinity | Mixed-Mode | Reversed Phase | Activated |
|---|---|---|---|---|---|
| CIMac AAV Full/Empty | CIMac OH | CIMac Oligo dT18 | CIMac PrimaS® | CIMac SDVB | CIMac CDI |
| CIMac pDNA | CIMac C4 HLD | CIMac HDZ-Affinity | CIMac XY | ||
| CIMac Adeno | CIMac r-Protein A | CIMac HDZ | |||
| CIMac QA | CIMac r-Protein L | ||||
| CIMac QA HR | CIMac r-Protein G | ||||
| CIMac DEAE | |||||
| CIMac COOH | |||||
| CIMac SO3 | |||||
| CIMac EDA-AEX/Activated | |||||
| AAV | Adenovirus | mRNA | pDNA | Other Large Biomolecules | Proteins |
|---|---|---|---|---|---|
| CIMac QA HR | CIMac Adeno | CIMac Oligo dT18 | CIMac pDNA | CIMac QA | CIMac r-Protein A |
| CIMac AAV Full/Empty | CIMac PrimaS® | CIMac C4 HLD | CIMac DEAE | CIMac r-Protein L | |
| CIMac C4 HLD | CIMac COOH | CIMac r-Protein G | |||
| CIMac SO3 | CIMac HDZ-Affinity | ||||
| CIMac EDA-AEX/Activated | |||||
| CIMac OH | |||||
Virus Quantification
Rapid Virus Quantification Using the Virus Counter Platform
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.
Explore the Virus Counter® Platform
Virus Counter® platform rapidly and precisely quantifies total virus particles:
- Accelerate time-to-result and time-to-market
- Gain real-time titer insights
- Increase product safety and quality by in-depth sample characterization
Tailored Analytical Methods
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.
Related Assets
Using PATfix® Analytical HPLC Platform to Optimize Lysis Conditions in pDNA Downstream Processing
PDF | 1.5 MB
Combining the Sensitivity of the PATfix® HPLC Platform With Ultracentrifugation for AAV Characterization
PDF | 948.3 KB
Fast Purification and Analysis of Influenza A Virus Using CIMac Monolith Columns
PDF | 1.1 MB
Comparison of Fluorescence and Multi-Angle Light Scattering for Rapid Quantitation of Bacteriophage
PDF | 577.7 KB
Orthogonal Characterization of AAV Samples by Simultaneous Monitoring of Multiple Analytical Parameters During Chromatography
PDF | 1.1 MB
