. 2023 Mar 15;32(1-2):17–32. doi: 10.1007/s11248-023-00335-z

Table 1.

Potential manufacturing standards for gene drive-modified mosquitoes

Standard release criteria	Description for other public health products^,*	Interpretation for GDMMs
IDENTITY/PURITY	Determination of which ingredients the product must contain and which it may contain	Description of the composition, copy number, and location of the transgenic construct
POTENCY/STRENGTH	Clinical efficacy, percentage of active ingredient in the product	Performance, competitiveness of transgenic mosquitoes with regard to their wild counterparts Strength of the gene drive construct, measured as spread through a population
QUALITY	Ability to demonstrate consistency in meeting identity and potency standards	Ability to demonstrate consistency in meeting identity and performance standards

Standard release criteria

Description for other public health products^*,**

Interpretation for GDMMs

IDENTITY/PURITY

Determination of which ingredients the product must contain and which it may contain

Description of the composition, copy number, and location of the transgenic construct

POTENCY/STRENGTH

Clinical efficacy, percentage of active ingredient in the product

Performance, competitiveness of transgenic mosquitoes with regard to their wild counterparts

Strength of the gene drive construct, measured as spread through a population

QUALITY

Ability to demonstrate consistency in meeting identity and potency standards

Ability to demonstrate consistency in meeting identity and performance standards