Expansion in characterisation and development support for mRNA vaccines and therapeutics.
mRNA Development Support
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.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance