Analytical & Stability Testing
Manufacturing a Better Future
What We Offer:
- Analysis of plasmid DNA, mRNA, cap analogs, etc.
- Assay/Method development, qualification, validation, and verification
- Support with design and implementation of stability studies on nucleic acid products
- Suite of qualified and calibrated analytical equipment for rapid bioburden/sterility testing, UV-Vis spectrophotometry, endotoxin testing, sanger sequencing, microscopy, microbiological analysis, compendial testing, chromatography, etc.
You Can Count on Us For:
- Strong technical capabilities and expertise for analytical testing, review, and release of critical raw materials and finished products with detailed certificate of analysis supplied
- Quality management system with good documentation practices implemented with CAPA and deviation handling procedures in place
Analytical panel for testing and stability studies
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| Test | Microbial Stock | Plasmid DNA | mRNA | Cap analog |
|---|---|---|---|---|
| Concentration Analysis by Spectrophotometry | Y | Y | Y | Y |
| Product Appearance | Y | Y | Y | Y |
| Restriction Endonuclease Analysis | Y | Y | ||
| Sequence Identity by Sanger sequencing | Y | Y | ||
| Bioburden Testing | Y | Y | Y | |
| Conductivity Analysis(USP <644>) | Y | Y | Y | |
| Osmolality Analysis (USP<785>) | Y | Y | Y | |
| pH Analysis (USP<791>) | Y | Y | Y | |
| Endotoxin Testing by Kinetic Chromogenic LAL assay | Y | Y | Y | |
| Sterility Testing (USP <71>) | Y | Y | Y | |
| Purity Analysis by HPLC | Y | Y | Y | |
| Identification by Agarose Gel Electrophoresis | Y | Y | ||
| Identification by Capillary Gel Electrophoresis | Y | Y | ||
| Purity Analysis by Agarose Gel Electrophoresis | Y | Y | ||
| Purity Analysis by Capillary Gel Electrophoresis | Y | Y | ||
| Purity Analysis by Spectrophotometry | Y | Y | ||
| Quantitation of Residual Protein by BCA or NanoOrange™ -based assay | Y | Y | ||
| DNA Homogeneity/Topology by Agarose gel electrophoresis | Y | |||
| DNA Homogeneity/Topology by HPLC | Y | |||
| Quantitation of Residual Antibiotics by ELISA | Y | |||
| Quantitation of Residual Host Genomic DNA by qPCR | Y | |||
| Quantitation of Residual Host RNA by RiboGreen®-based assay | X | |||
| Analysis of Bacterial Culture Viability | Y | |||
| Bacteriophage Testing | Y | |||
| Copy number determination by qPCR | Y | |||
| Generation of Bacterial Growth Curve | Y | |||
| Identification by Gram Staining | Y | |||
| Purity Screening for Microbial Cultures | Y | |||
| Retention Testing | Y | |||
| Capping Efficiency Analysis by HPLC | Y | |||
| Identification by Mass Spectrometry | Y | |||
| Poly-A tail length Analysis by Capillary Gel Electrophoresis | Y | |||
| Quantitation of Residual dsRNA by Dot Blot Analysis | Y | |||
| Quantitation of Residual Plasmid DNA by qPCR | Y | |||
| Sequence Identity by Reverse Transcription Followed by Sanger sequencing | Y | |||
| Elemental Impurities by Mass Spectrometry | Y | |||
| Identification by NMR Spectroscopy | Y | |||
| Ionic concentration by Ion Chromatography | Y | |||
| Residual Solvent Analysis by Gas Chromatography | Y |
Request Information From
CALGARY
335 - 25 Street S.E.
Calgary, Alberta
T2A 7H8
PHONE NUMBER
866 678 4762
(86NorthRNA)
info@northernrna.com