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:
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General quality
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Identity
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Quantity
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Purity & Integrity
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Potency
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Process related impurities
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Nano-delivery system
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Packaging
Your reliable analytical partner:
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Thorough regulatory, scientific and technical monitoring and skilled teams
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Commitment to providing the highest quality services and generating reliable data in order to enable our clients to consistently market safe products.
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Compliance with all applicable EMA, FDA and ICH regulations
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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 |
QUANTITY
| Content (RNA concentration) | UV spectroscopy / Slope Spectroscopy (SoloVPE) / Anion Exchange Chromatography (UV) |
PURITY & INTEGRITY
| Size | SEC (UV, RI, MALLS) / cGE (LIF) |
| Purity | Ion-exchange chromatography (UV), IP-RP-(U)HPLC (UV) |
| 5' Capping efficiency | (U)HPLC (UV, MS) |
| 3’ poly(A) tail length and percentage | (U)HPLC (UV, MS) |
| Residual dsRNA | ELISA |
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, Fluo, CAD, Conductimetry) / ELISA / ICP (OES, 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-based assay |
| Encapsulation efficiency | Fluorescence-based assay |
| Lipid analysis (identity, content & impurities) | (U)HPLC (CAD, MS) |
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 |
