خدمات کنترل کیفی

Molecular Tests

  • Plasmid DNA Molecular Size & Integrity Test
  • Plasmid DNA Restriction Map Analysis
  • Plasmid DNA Copy Number Quantification

Impurities

  • Residual Plasmid DNA Template in Synthetic mRNA
  • dsRNA Contamination Detection (ELISA)
  • E.coli Host Cell DNA Analysis
  • E.coli Host Cell RNA Analysis
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RNA-related tests

  • RNA Concentration Determination
  • RNA Sequence Verification (qRT-PCR)
  • mRNA Molecular Size & Integrity Test
  • Small RNA Molecular Size & Integrity Test
  • mRNA Primary Sequence Analysis (HPLC)
  • mRNA Sequence Analysis (NGS)*
  • Percentage of Poly-A Tailed mRNA
  • Percentage of 5′-Capping Efficiency
  • mRNA Encapsulation Efficiency (Fluorescence Assay)
  • mRNA Encapsulation Efficiency (Gel Retardation Test)

DNA-related tests

  • DNA Concentration Determination
  • Plasmid DNA Identity Verification (Sanger Sequencing)
  • Plasmid DNA Topology Analysis
  • Plasmid DNA Linearization Efficiency Analysis

* These tests are not currently performed directly at ReNAP and are outsourced instead, and the final results are processed, interpreted and reported by ReNAP QC Department.

Biochemical Tests

  • RNA Polymerase Promoter Specificity Test
  • Re-ligation Assay (Restriction Enzyme Cutting Accuracy)
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  • Total Protein Concentration Determination (BCA)
  • Protein Purity Analysis by SDS-PAGE
  • E.coli Host Cell Protein Analysis
  • RNase Inhibitor (RI) Activity Assay
  • Phosphatase Activity Assay (pNPP)
  • RNA polymerase Activity Assay
  • Restriction Enzymes Activity Assay
  • Exonuclease Activity Assay
  • Endonuclease Activity Assay
  • Non-Specific DNase Activity Assay
  • RNase Activity Assay
  • Latent RNase Activity Assay
  • dNTPase Activity Assay
  • NTPase Activity Assay

Cellular Tests

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  • Eukaryotic Cell Line Authentication
  • Cell Viability Test
  • Cytotoxicity Test (MTT Assay)
  • Immuno-Cyto Chemistry Assay (ICC)
  • Immuno-Histo Chemistry Assay (IHC)
  • In Vitro Expression Assay (Western Blotting)
  • In Vitro Expression Assay (Flow Cytometry)

Microbiological Tests

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  • E.coli Identification (16srRNA Genetic Analysis)
  • Culture Purity test*
  • Gram Staining test
  • Bacterial Viability Test
  • Plasmid Retention Test
  • Microbial Limit Test*
  • Bioburden Test*
  • Bacterial Endotoxin Test (Gel Clot)
  • Sterility Test*
  • Presence of Bacteriophage

* These tests are not currently performed directly at ReNAP and are outsourced instead, and the final results are processed, interpreted and reported by ReNAP QC Department.

Physico-Chemical Tests

  • Chemical Compound Identification (NMR spectroscopy)*
  • Chemical Compound Identification (Mass spectroscopy)*
  • Chemical Compound Identification (Raman spectroscopy)*
  • Chemical Compound Identification (IR spectroscopy)*
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  • Physical Appearance
  • Extractable Volume Measurement*
  • Particulate Matter Test*
  • Osmolality Test*
  • pH Determination

Nano-Particles

  • Nanoparticle Size & Polydispersity (PDI) Determination (DLS)
  • Nanoparticle Zeta-potential Determination (DLS)

Chemical Compound Identification

  • Heavy Metal Content (ICP-Mass)*
  • Chemical Compound Identification (TLC)

* These tests are not currently performed directly at ReNAP and are outsourced instead, and the final results are processed, interpreted and reported by ReNAP QC Department.

Special Tests

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  • SARS-COV2 Pseudo type Virus Neutralization Tests (pVNT)
  • Interferon β Quantification Assay

On-Demand QC Contract Service Packages

Analytical Method Development

QC Consulting

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Certificate of Analysis Compilation

  • Bacterial Cell Line
  • Plasmid DNA (Supercoiled & Linearized)
  • mRNA
  • mRNA-LNP
  • Specific Enzymes & Proteins

Comprehensive Stability Studies

Bioinformatic Analysis

  • q-PCR Data Interpretation
  • Next Generation Sequencing Analysis