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NGS as a Multi-Attribute Method (MAM) for Simultaneous Critical Quality Attribute Measurement of Gene Therapy Products

April 20, 2023

Available gene therapies have had remarkable outcomes yet there have been multiple cases where other therapeutics have led to unforeseen outcomes and clinical holds. To avoid that and guarantee that the intended therapeutic is developed, in-process testing is required to ensure these therapeutics maintain critical quality attributes (CQAs). For gene therapies, CQAs include identity, potency, and safety.

Establishing and monitoring these attributes throughout development and manufacturing can help to ensure the product developed is safe and fit for its purpose. Regulatory authorities such as the FDA and the EMA also request detailed documentation regarding CQAs when companies apply for an IND. For this, a streamlined assay portfolio and the right technology that allows determining multiple attributes of a therapeutic simultaneously would be highly beneficial.

Here we present Next-Generation Sequencing (NGS), as the multi-attribute method for CGT products as it eliminates the need for implementing several different assays to determine CQAs by streamlining multiple assays. The vast amount of useful information obtained from NGS makes it easier, faster, and more cost-efficient to examine the critical quality attributes of gene therapy products answer the questions.

Download this poster to learn how the NGS-based workflows of Genedata Selector® eliminate the need for implementing multiple different assays to determine CQAs and discover:

  • How our technology agnostic platform supports all types of NGS-based assays throughout the GT vector development process 
  • How the platform's wizard-based Playbooks simplify and automate NGS-based assays for GT development 
  • How Genedata Selector enables data traceability for all analyses and report generation for internal and external audits
  • How our enterprise software facilitates integrity analysis and provides clear go/no-go thresholds for faster and better-informed decisions

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