CCQM Task Group on Gene Delivery Systems (CCQM-TG-GDS)

Period of activity: start September 2025 to end March 2027

Terms of Reference

Task Group activities

• To prioritize, with external stakeholders, needs and gaps for reference measurement methods and reference materials, taking into account international documentary standard or best practice guideline activities, for the quantification of gene delivery systems, endorsing the recommendation of the CCQM Workshop report on “Metrology for viral vectors as molecular tools”¹.
  Note: gene delivery systems are defined as systems to introduce foreign nucleic acid into target or host cell and include biologically-derived viral vectors and extracellular vesicles, as well as manufactured systems using proteins, lipids, polysaccharides and synthetic polymers.
• To prioritize proposed comparison activities to be addressed by the international metrology community relating to the prioritized measurands of gene delivery systems.
• To develop knowledge transfer mechanisms supporting the metrology of gene delivery systems, within the international metrology community and to user communities.
• To develop reference measurement method proposals for prioritized measurands, to be addressed within CCQM WG comparison exercises, that are able to demonstrate capabilities for traceable and quantitative characterization of product attributes of gene delivery systems, vetted for relevance and prioritized by the end-user community:
  • Workshop with CCQM Bioanalytical WG members (@NIST, Q3 2025)
  • Workshop with external stakeholders (Virtual, Q4 2025/Q1 2026)
  • First study to be scoped (Q4 2026) and implemented (Q1 2027)
  • At least one further study proposal to be prioritized during 2027.
• To investigate target measurement uncertainties for identified product attributes of gene delivery systems.
• To investigate development of an exemplar draft target product profile that guides users towards definition of a set of product attributes (containing both minimally acceptable and preferred criteria).

¹Campbell et al. Biologics 2024, 4(2), 187-201. Conference Report: Standards and Metrology for Viral Vectors as Molecular Tools - Outcomes from a CCQM workshop. https://doi.org/10.3390/biologics4020013