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Analytical Development

Rigorous quality control has always been a challenge in the manufacturing of gene therapy drugs. In parallel to process development, VectorBuilder can provide the full range of analytical development services capable of developing, optimizing, qualifying and validating in-process and release QC assays tailored to individual gene therapy vectors. We can also provide drug stability studies to ascertain vector shelf life under various storage and transport conditions.

QC Assays

  • General/physical properties

    Appearance, concentration, pH, extractable volume, osmolality, aggregation

  • Identity

    Restriction enzyme digestion, sequencing, agarose gel electrophoresis, SDS-PAGE, immunoassay

  • Strength/potency

    • Physical titer: qPCR, ddPCR, immunoassay, OD260/280
    • Infectious titer: plaque assay, TCID50
    • Expression of the transgene: transduction test, Western blot, RT-qPCR, flow cytometry
  • Purity

    • Product related
      • Full/empty viral particle ratio: TEM
      • Supercoiled plasmid ratio: agarose gel electrophoresis, HPLC
    • Host cell related
      • Host cell protein: immunoassay, SDS-PAGE, silver stain, Micro BCA, BCA, HPLC
      • Host cell DNA: qPCR, agarose gel electrophoresis
      • Host cell RNA: agarose gel electrophoresis, RT-qPCR, fluorometric quantification
    • Process related
      • Residual plasmid DNA: qPCR
      • Residual benzonase: immunoassay
      • Residual BSA: immunoassay
      • Residual PEI: HPLC
      • Residual antibiotic: immunoassay
  • Safety

    • Sterility: direct inoculation, membrane filtration sterility test
    • Endotoxin: kinetic chromogenic assay (KCA)
    • Mycoplasma: qPCR, culture method, indicator cell culture method
    • Replication competent virus: qPCR, immunoassay, Southern blotting
    • Adventitious virus: qPCR, in vitro cell culture
    • Presence of viral oncogenes such as E1A and SV40: qPCR

Stability Studies

Drug stability studies are essential for ensuring that the quality of DS/DP is maintained during their shelf life. Our stability studies are performed following ICH guidelines to assess how the potency and safety attributes of the gene therapy vectors are influenced by environmental factors (e.g. pH, temperature, light) under planned storage conditions or forced degradation conditions.


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