mRNA

mRNA is a new class of therapeutics designed to instruct patients’ own cells to produce a protein that can treat, cure or prevent diseases. mRNA therapeutics are being developed as vaccines against infectious diseases, as cancer immunotherapy, and as protein replacement therapy for rare diseases.

Building on its considerable experience in the analysis of complex innovative drugs, Quality Assistance is continuously advancing ways to support the development of your mRNA-based therapeutics and expanding its related machinery and equipment.

Analytical services for mRNA-based therapeutics:

  • General quality

  • Identity

  • Quantity

  • Purity & Integrity

  • Potency

  • Process related impurities

  • Nano-delivery system

  • Packaging

Your reliable analytical partner:

  • Thorough regulatory, scientific and technical monitoring and skilled teams

  • Commitment to providing the highest quality services and generating reliable data in order to enable our clients to consistently market safe products.

  • Compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

GENERAL QUALITY
Appearance Visual inspection
pH  
Osmolarity  
Extractable volume  
Particulate matter Optical microscopy / Light Obscuration / Imaging Particle Analysis
IDENTITY
Oligonucleotide mapping (U)HPLC (UV, MS)
Sequence RT-PCR, NGS (available soon)
QUANTITY
Content (RNA concentration) UV spectroscopy / Slope Spectroscopy (SoloVPE) / Anion Exchange Chromatography (UV)
PURITY & INTEGRITY
Size distribution SEC (UV, RI, MALLS) / cGE (UV)
Purity Ion-exchange chromatography (UV), IP-RP-(U)HPLC (V)
5' Capping efficiency (U)HPLC (UV, MS)
3’ poly(A) tail length and percentage (U)HPLC (UV, MS)
Residual dsRNA ELISA, Dot Blot
POTENCY
Cell-based assays (in vitro expression) Different read-outs
PROCESS RELATED IMPURITIES
Residual DNA template RT-qPCR
Process contaminants CE / GC (FID, MS) / (U)HPLC (UV, MS) / ELISA / ICP (MS)
Residual solvents HS-GC (FID, MS) / (U)HPLC (UV, MS)
Elemental impurities ICP (OES, MS)
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, endpoint) / Monocyte Activation Test / Recombinant Factor C
NANODELIVERY SYSTEM
Size distribution DLS / A4F (UV, RI, MALLS)
Surface charge / zeta potential M3-PALS (Zetasizer)
RNA content Fluorescence assay
Encapsulation efficiency Fluorescence assay
Lipid analysis (identity, content & impurities) (U)HPLC (CAD)
PACKAGING
Leachables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
Container Closure System Integrity Bubbling / Dye ingress (methylene blue, fluorescence) / Microbial ingress
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