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.
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.
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.
Monolithic Analytical Columns by Chemistry and Application
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™ IDA |
CIMac™ Adeno | CIMac™ C4 A | CIMac™ r-Protein A | |
CIMac™ QA | CIMac™ r-Protein L | ||
CIMac™ DEAE | CIMac™ r-Protein G | ||
CIMac™ COOH | CIMac™ HDZ-Affinity | ||
CIMac™ SO3 | |||
CIMac™ EDA-AEX/Activated | |||
AAV | Adenovirus | mRNA | pDNA | Other Large Biomolecules | Proteins |
|---|---|---|---|---|---|
CIMac™ AAV Full/Empty | CIMac™ Adeno | CIMac™ OligoDT18 | CIMac™ Plasmid DNA | CIMac™ QA | CIMac™ C4 A |
| CIMac™ PrimaS | CIMac™ C4 HLD | CIMac™ DEAE | CIMac™ IDA | ||
CIMac™ C4 HLD | CIMac™ COOH | CIMac™ r-Protein A | |||
CIMac™ SO3 | CIMac™ r-Protein L | ||||
CIMac™ EDA-AEX/Activated | CIMac™ r-Protein G | ||||
CIMac™ OH | CIMac™ HDZ-Affinity | ||||
CIMac™ H-bond ADC | |||||
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® 3100 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.
