GTMPs (Gene Therapy Medicinal Products)

Quality Assistance offers extensive experience with analytical development and validation and GMP/GLP compliant laboratories for your gene therapy medicinal products development. Partner with us and centralise your analytical needs on one site.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development
  • Validation of analytical methods as per ICH guidelines
  • Product characterisation
  • Stability studies
  • Batch testing
  • Bioanalysis
Identity of cells by phenotypic/genotypic markers RT-PCR / Q-PCR / FACS
Presence and integrity of vector Restriction endonuclease mapping
Measurement of vector gene expression Cf. potency
Appearance Visual inspection
Extractable volume  
Residual moisture (if lyophilised) KF titration
Cross-contamination with other products  Restriction digest / Gel electrophoresis
Transgene expression  Immunoassays / SDS-PAGE / RT-PCR
Transcription unit DNA confirmation  Restriction enzyme mapping / PCR
Complex identity (proteins, lipids, polymers) Peptide Mapping (UPLC (UV, QTOF, IonTrap), MALDI-TOF) / GC (MS) / IEX / RID
Plasmid, DNA identity  Restriction enzyme mapping / PCR
DNA homogeneity Electrophoresis (agarose) / Bioanalyzer / CE
Genomic structural integrity PCR
Plasmid-selection markers PCR / To be discussed
Plasmid DNA conformation (monomeric supercoiled, relaxed monomer, linear, ccc [circular covalently closed] vs oc [open circular])  Electrophoresis (agarose) / CE
Optical density ratio (A260/A280 Spectrophotometer
Viral protein profile (defective or immature particles)  (U)HPLC (UV, MS)
Structural protein analysis  (U)HPLC (UV, MS) / SDS-PAGE / Peptide Mapping (UPLC (UV, QTOF, IonTrap), MALDI-TOF)
Complex purity (proteins, lipids, polymers)  Peptide Mapping (UPLC (UV, QTOF, IonTrap), MALDI-TOF) / GC (MS) / IEX
(Viral-) vector purity  (U)HPLC (UV) / Spectrophotometer
Viral capsid purity  SDS-PAGE
Homogeneity of size  Electrophoresis (agarose)
Total protein Micro BCA
Gene-vector titer, infectious titer Bioassays / Q-PCR
Plasmid DNA weight, DNA titer UV / PicoGreen / Q-PCR
Viral DNA copies Q-PCR
Vector copy number ELISA / Q-PCR
Labeled dose UV / Q-PCR
Function of expressed gene Cell-based assays
Infection, transfection/transduction Cell-based assays / Q-PCR
Transgene expression after transfection in cells Cell-based assays / Western Blot / ELISA / RT-PCR
In Vitro viral genome copy number in cells Q-PCR
Vector aggregates A4F/HF5 (UV, RI, MALS) / DLS
Transgene product Cf. Product sheet «Proteins»
Residual DNA (bacterial chromosomal DNA, genomic DNA, plasmid DNA, HCDNA) Q-PCR
Residual proteins (HCP, bacterial proteins) (SDS-)PAGE / Western Blot / ELISA / ECL (MSD)
Medium components (FBS, antibiotics, cytokines, hormones, BSA, enzymes, antibodies, growth
ELISA / ECL (MSD) / (U)HPLC (UV, FLUO, MS) / Luminex
Process contaminants (serum, CsCl, EtBr, Iodixanol, alakaline detergents, acetate, PEG) CE / GC (MS) / (U)HPLC (MS) / ELISA / ICP (MS)
Residual benzonase ELISA
Residual solvents HS-GC (FID, MS) / (U)HPLC (UV)
Residual salts (U)HPLC (conductimetry) / IEX (conductimetry) / ICP (OES, MS)
Elemental impurities ICP (OES, MS)
Microbiology / Endotoxins Bioburden / Sterility (filtration, direct inoculation) / Endotoxins (kinetic, end point)
Container closure system integrity Bubbling / Dye ingress / Microbial ingress
Leachables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>
Immunogenicity (on transgene product) ELISA / ECL (MSD) / Cell-based assays (neutralization) / Luminex / Biacore
PK/TK / Biodistribution / Shedding Q-PCR / ELISA / ECL (MSD) / Luminex / Biacore
Biomarkers ELISA / ECL (MSD) / UPLC (MS/MS) / Luminex
Vehicles / Buffers Q-PCR / UV
Download the product sheet for more information