Project: Viral Vector Functional Titer Assessment and Quantification

Type: Standards Advancement Project

Partners: ISO/TC 276 U.S. Working Group 3 (US WG4) and the SCB Gene Therapy Sector Working Group

Description:

The field lacks standards for viral vector characterization and quantification approaches, leading to difficulty comparing measurements of critical quality attributes (CQAs) between different labs and manufacturers, as well as imprecise or inaccurate viral vector counts or miscommunication due to differences in data reporting practices. Researchers and manufacturers employ a variety of methods to quantify viral vector CQAs, but final metrics may vary based on the individual technique used, creating uncertainty around data reliability in an already complex biological system.

Standards in this area could help harmonize manufacturers’ characterization, design, validation, and quantification measurement and reporting processes. These improvements would ease technology transfer and support assay validation. Improved comparability will also help improve accuracy of dosing and increase the consistency of data across the product life cycle.

SCB has organized a working group and is coordinating development of a standard on the assessment and quantification of the CQAs, functional titer, and physical titer of viral vectors.

Progress:

(learn more about the standards advancement process)

Assembled a Working Group: SCB initiated working group meetings to coordinate the standard advancement effort.

Conducting a Feasibility Assessment: In December 2020, SCB organized a meeting of experts from multiple stakeholder groups to discuss barriers and opportunities for potential standard topics. SCB developed a feasibility report detailing the barriers and opportunities for a standard.

Began Drafting Standard: The standard was accepted as a new work item by ISO in January 2022, and drafting is currently under way. SCB will coordinate the development of the standard as it moves through the ISO process.

Get Engaged:

SCB needs subject matter experts like you to join the working group — contact SCB for more information.