Discovery, Development, Manufacturing and Quality Control of Immunotherapy Assays

Accelerate your pipeline

 

Accelerate your pipeline with consistent results across departments. Developing immunotherapies is complex but conducting your experiments should be easy. Is translating your assays from the development phase into  quality systems for manufacturing a burden? Discover how Axion BioSystems’ immunotherapy potency assays can save time, cut costs, and simplify your workflow. From the first experiments to qualifying each new batch, Axion’s Maestro Z and Maestro ZHT platform can streamline your process.

 

Measuring Immunotherapy Potency

Although the pathways may differ, all immunotherapies aim to induce tumor-specific cytotoxicity. Since regulatory agencies require potency assays, preparing for this testing early in the discovery process can help lead to success down the line. Learn how the Maestro platform brings a simple, sensitive cell-killing assay to your pipeline throughout the process. 

 

Discover your target Discovery

Immuno-oncology therapy development has seen exponential growth in recent years, with nearly 5,000 agents and more than 500 targets under investigation in 2020. Quickly and efficiently assessing candidates is essential for finding the most effective cell therapies and keeping up in a fast-moving market.

Identify and rank immuno-oncology targets with the Maestro cytolysis assay: 

  • >>  Automation-friendly with no complicated steps or reagents
  • >>  Customizable throughput options
  • >>  Software integration with existing liquid handling systems
  • >>  Integrated barcode tracking system

Whether screening checkpoint inhibitors on cytotoxic T cells or developing a CAR T therapy or novel oncolytic virus, discover the next breakthrough with Axion’s Maestro platform. 

 

 

Download Axion's 21 CFR Part 11 Statement


Cell therapy development of product  Development

A lot goes into making an immuno-oncology product. Characterization data can tell you what you have but only cell killing assays can tell you if it works. The Maestro platform can provide you with the data you need to make decisions, with– noninvasive, real-time results that reveal the full cellular response profile.

Unlike endpoint assays which limit you to a snapshot in time, the Maestro platform captures the complex interactions between immune cells and target cancer cells over time. Process updates that shift cell-mediated toxicity kill curves, reduce long-term persistence, or alter the kinetics are all detected within a single plate.

Optimize your processes:

  • >>  CAR-gene transfection
  • >>  CAR-T cell proliferation
  • >>  CAR-T cell activation
  • >>  Cryopreservation
  • >>  QC potency assays

 

GMP compliant  Manufacturing and Quality Control

Cell-based assays can be notoriously difficult to validate, leaving frustrated scientists to say, “That’s biology!”

Tech transfer is often delayed because many assay platforms simply aren’t compatible with a regulatory environment. Consequently, assays optimized by the R&D team must be translated into one that is–adding time and expense that could be avoided with a little foresight. The Maestro platform is built with a regulatory environment in mind and GMP software (for FDA 21CFR11 compliance), so you can efficiently move your assays from development to QC with: 

  • >>  Automated acquisition 
  • >>  Audit trails 
  • >>  Digital signatures and ID 
  • >>  Barcode tracking

 

Don’t be caught off-guard when entering a clinical setting. Read our compliance statement for more information.