Adoptive cell therapies

Adoptive cell therapies, spearheaded by chimeric antigen receptor (CAR) T-cell therapy, are showing promise as innovative ways of treating patients with hematological malignancies and solid tumors including melanoma, breast cancer and sarcoma. Developing such a therapeutic presents substantial challenges including:

  • The assessment of pharmacodynamics (PD) and pharmacokinetics (PK)
  • The identification of the right risk-adapted dosing strategy to avoid strong cytokine-driven adverse effects and neurotoxicity
  • The prediction of unwanted toxicity due to certain tumor biomarkers also being expressed in normal tissues (on-target/off–tumor toxicity)
  • The development of better patient selection criteria

Additionally, since the genetic manipulation of autologous immune cells typically relies on the use of viral vectors , it is essential to:

  • Ensure the absence of replication-competent viruses in vector lots, ex vivo transduced cells, and clinical samples during follow-up monitoring of patients who have received such a treatment
  • Perform an analysis of viral genomic integration in the transduced immune cells (vector copy number or VCN)

Biogazelle has developed specific PCR-based workflows for VCN determination & RCR/RCL detection

To address some of these challenges Biogazelle has developed specific adoptive cell therapy workflows for VCN determination, replication competent retrovirus (RCR) or lentivirus (RCL) detection, as well as CAR-T and CAR-NK cell quantification. We can develop a test for any target of interest, validated as needed to fulfill your quality and regulatory requirements and thus offer a more sensitive alternative to immunohistochemistry for the analysis of the biodistribution of your CAR-T or CAR-NK cells.

Our workflows make use of highly sensitive and accurate PCR-based methods. Biogazelle’s founders are internationally recognized qPCR experts and our company has been at the forefront of digital PCR-based research since 2013. We serve as a reference laboratory for Bio-Rad’s QX200 Digital Droplet PCR system in Europe and use our experience to provide digital PCR services both in clinical research and clinical trial settings.

Biogazelle has established a successful track record in accelerating adoptive cell therapy development

Some examples of our track record in the adoptive cell therapy area include:

  • RCL detection in peripheral blood mononuclear cells (PMBC) based on vesicular stomatitis virus G glycoprotein (VSV-G) measurement by qPCR
  • Analysis of the biodistribution of CAR T-cells in preclinical models by ddPCR through the measurement of a CAR-T cell-specific gene and a human-specific gene, both in combination with a mouse reference gene
  • RCR detection in human PBMCs through gibbon ape leukemia virus (GALV) gene detection in parallel to human telomerase reverse transcriptase (hTERT) analysis by qPCR
 
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