At-line Analytical Solutions

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.

Avoid labor-intensive work

Move away from traditional, labor-intensive methods including ddPCR, ELISA, and TCID50
 

Cut required workflows in half

Currently two methods are needed to determine both E/F AAV capsids. Analytical chromatography provides one technology instead of two

Make decisions faster

Get direct insight into samples with at-line analytical solutions



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At-line HPLC

HPLC monitoring and quantitation of large biomolecules delivering rapid, high-resolution separations in minutes.

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Automated Virus Quantification

A unique automated platform for real-time tracking of viral particles and quantification of total intact particles.

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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.


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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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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

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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® PrimaSCIMac® 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

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Cornerstone® Biomanufacturing Development Services

Sartorius experts represent extensive experience in chromatography and purification of biomolecules as well as analytical methods development

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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

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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

Application Note: Comparison of HIC Monolithic Support for Sample Displacement Chromatography of pDNA

PDF | 468.2 KB

Application Note: In-Process Control of pDNA Production on CIMac pDNA Analytical Column

PDF | 463.7 KB

Poster: Fast HPLC Analytics for IVT Reaction Characterization and...

PDF 604.0 KB

Poster: Estimation of Empty | Full AAV10 Particle Ratio Using...

PDF 422.4 KB

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