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Applications and Solutions

Comprehensive Solutions for Purification and Analytical Chromatography

Tosoh Bioscience delivers advanced chromatography technologies that cover the entire workflow--from high-resolution analytical characterization to large-scale purification. Explore how our products support critical applications across biopharmaceutical and specialty industries.

Diagnostics

The Complete Picture Using Tosoh HPLC for HbA1c Testing

Tosoh's HPLC systems are renowned for their automation and high-throughput capabilities, making them ideal for mid- to high-volume laboratories that require reliable, accurate, and precise HbA1c results.

The systems use a proprietary, non-porous polymer resin column in their ion-exchange chromatography, ensuring high-resolution chromatograms and efficient separation.

In Tosoh’s ion-exchange methodology, the glycated hemoglobin components are separated based on their different electrical charges. This is achieved by introducing buffers of varying ionic strength during the separation process. The result is a direct determination of stable HbA1c, clearly distinguishing it from labile HbA1c on the chromatogram.

This precise and efficient separation ensures that the HbA1c results are both accurate and reliable, which is critical for effective diabetes management and monitoring.

Tosoh GR01 HPLC Analyzer »

Tosoh G8 HPLC Analyzer »

The AIA Automated Immunoassay Family

From 36 to 200 tests per hour, there is a Tosoh AIA system for every need. The Automated Immmunoassay (AIA) systems are fully equipped to meet the demands of laboratories now and in the future. The accuracy and result integrity of Tosoh products allows for your continued success and growth.

Tosoh combines instrument reliability with exclusive AIA-Pack test cups that provide the highest standard of quality, precision and accuracy in clinical diagnostics.

Tosoh AIA Systems

AIA-2000 » 
Automated Enyzme Immunoassay System 
200 tests per hour

AIA-900 » 
Automated Enyzme Immunoassay System 
- 90 tests per hour

AIA-360 » 
Automated Enyzme Immunoassay System 
- 36 tests per hour


The AIA-PACK Test Cup 
One Reagent for all Tosoh AIA Systems 
•  All Tosoh AIA analyzers utilize the same reagents 
•  The AIA-Pack reagents consist of unique unit dose test cups. 
•  Each test cup contains all necessary components to perform the analysis 
•  There is no reagent preparation - and no reagent waste. 
•  Along with calibration stability of 90 days, small volume assays can be run in-house

Unit Dose Test Cup Reagent Technology

Separation & Purification

Antibodies

Antibodies are the foundation of many biologics therapeutics, including monoclonal antibodies (mAbs), bispecifics, and antibody-drug conjugates.

Purification:

  • Multi-step processes for capture, intermediate, and polishing to achieve therapeutic-grade purity.
  • Address challenges such as high titers, aggregate removal, and scalability for commercial production.

Analytical Characterization:

  • Aggregate detection and charge variant profiling to ensure stability and efficacy.
  • Structural analysis for regulatory compliance and comparability studies.  
     

Therapeutic Nucleic Acids

The rapid growth of mRNA vaccines and gene-based therapies demands robust chromatographic solutions.

Purification:

  • Scalable workflows for plasmid DNA, mRNA, and oligonucleotides to remove impurities like endotoxins and residual solvents.
  • High-resolution separation for large, fragile molecules without compromising integrity.

Analytical Characterization:

  • Size and charge analysis for quality control.  
    Integrity and purity checks for regulatory submissions. 

Gene Therapy

Viral vectors such as Adeno Associated Virus (AAV) and Lentivirus (LV) are essential for delivering genetic material in advanced therapies.

Purification: 

  • High-efficiency capture and polishing of AAV, lentivirus, and other vectors to maintain infectivity and purity.  
    Removal of host cell proteins, DNA, and empty capsids for safety and efficacy. 

Analytical Characterization: 

  • Monitoring impurities, aggregates, and stability throughout development and production. 

Polymers

New sustainable synthetic or natural polymers, polymer-based drug delivery vectors, and common engineering plastics, require thorough characterization to develop well-defined and safe products.

Analytical Characterization: 

  • Molecular weight and size distribution analysis using advanced chromatographic separation and detection techniques.  
  • Determination of polymer blends and and composition for in-depth characterization.

Why Tosoh Bioscience?

End-to-End Expertise

We provide solutions for both preparative purification and analytical characterization, ensuring seamless integration from early research to full-scale production.

Scalable Innovation

Our technologies grow with your process—whether you’re developing a new molecule in the lab or manufacturing at commercial scale, Tosoh Bioscience delivers consistent performance and reliability.

Global Support Network

With technical experts and resources worldwide, we offer guidance, training, and troubleshooting to keep your processes running smoothly.

Regulatory Confidence

Our products and methods are designed to meet global regulatory standards, helping you achieve compliance and accelerate time-to-market without compromising quality.

Decades of Leadership  
As pioneers in chromatography, we combine proven experience with continuous innovation to support the evolving needs of biopharmaceutical and specialty industries.

Explore application notes, technical resources, and case studies to learn how Tosoh Bioscience can help you achieve your goals.

 

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