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Expanding AAV Process and Characterization Analytical Technologies

Gene therapies promise to become revolutionary curative treatments, yet realization of this potential requires advances in biomolecular understanding to be on par with quality standards of today’s state-of-the-art treatments (e.g., monoclonal antibodies).
Categories
Cell and Gene therapies
Assays
Project status
100% Completed

Industry Need

  • Gene therapies promise to become revolutionary curative treatments, yet realization of this potential requires advances in biomolecular understanding to be on par with quality standards of today’s state-of-the-art treatments (e.g., monoclonal antibodies). 
  • Characterization of mAbs has evolved during the past 30 years to include an advanced toolbox of measurements to clarify identity, quality, and stability. In turn, numerous structure/function and structure/stability correlations have been identified, allowing product quality attribute (PQA) criticality to be assessed using a risk-based approach. 
  • Innovation and adaptation beyond existing high-resolution methods are needed to build similar knowledge around gene therapy delivery vectors. 


Solution

NC State, in partnership with NIST and Pfizer, aims to pioneer the combination of multi-attribute method (MAM) mass spectrometry and ion mobility spectrometry (IMS) into the gene therapy space. Modality-targeted development will provide the specificity and speed necessary to meet the emerging demands of process development and set the industry standard for product knowledge and control. 

Updates, Related Publications, and Deliverables

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Project Lead

North Carolina State University

North Carolina State University

Participating Organizations

Federal Stakeholder:  National Institute of Standards and Technology

Federal Stakeholder: National Institute of Standards and Technology

Pfizer, Inc.

Pfizer, Inc.