Expansion in characterisation and development support for mRNA vaccines and therapeutics.
Intertek Pharmaceutical Services has expanded laboratories services supporting mRNA vaccine and therapeutic products. At our GLP / GCP / GMP laboratories, scientists can test mRNA drug substance or drug products to help you confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA. Additionally, our experts provide mRNA specific methods including integrity, potency, capping efficiency, residual DNA template, residual dsRNA and delivery system testing.
Key CMC information on the mRNA critical quality attributes and corresponding justification of acceptance criteria has yet to be formally established in regulatory guidance for mRNA. Our scientists have established a core set of advanced "superhero" analytics to characterize DNA templates and RNA transcripts can be deployed to build effective quality control with a focus on the Fantastic Four - Capping Efficiency, Sequencing, Poly-A Tail, Residual dsRNA - as priority considerations to support CMC.
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