by: Junyan ZhangPosted on:

Critical Quality Attributes for mRNA

A Critical Quality Attribute (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should fall within appropriate limits, ranges, or distributions to ensure the desired product quality1. Table 1 outlines the CQA of mRNA.

CategoryQuality AttributeTesting Method
GeneralpHPh.Eur. 2.2.3, USP <791>
AppearanceClarity Ph.Eur. 2.2.1, Acc. USP <855>
Coloration Ph.Eur. 2.2.2, USP <790>
ContentmRNA content (yield)UV Spectroscopy
IdentityRNA sequence identitySanger
Integrity5′ capping efficiencyLC/MS, HPLC/UV
PolyA tail lengthLC/MS, HPLC/UV
Full length ratioCapillary electrophoresis
Product Related ImpuritiesdsRNADot blot/ELISA
Process Related ImpuritiesResidual enzymes/proteinNanoOrange
Residual DNA templateqPCR
Microbiological ControlBioburdenPh.Eur 2.6.12
USP <61> <62> <1115>
Bacterial endotoxinsPh.Eur. 2.6.14 USP <85>
Table 1. Critical quality attributes and testing methods for mRNA

Reference:

  1. https://www.hamiltoncompany.com/process-analytics/process-analytical-technology/critical-quality-attributes#:~:text=A%20CQA%20is%20a%20physical,to%20measure%20directly%20in%20production.

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