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
MCB/MVB & WCB/WVB
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
GENERAL QUALITY
Appearance Visual inspection
pH  
Osmolarity  
Extractable volume  
Residual moisture (if lyophilised) KF titration
IDENTITY
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
PURITY & INTEGRITY
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)
DOSE
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
POTENCY
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
PRODUCT-RELATED IMPURITIES
Vector aggregates A4F/HF5 (UV, RI, MALS) / DLS
Transgene product Cf. Product sheet «Proteins»
PROCESS-RELATED IMPURITIES
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
factors)		 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)
PACKAGING
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 & PK/TK & BIOMARKERS
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

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