Beyond the standard laboratory tests performed in the course of clinical studies, the evaluation of advanced-therapy medicinal products and DNA-based vaccines required a set of specific analysis that are not supported by most hospitals or Clinical Research Organizations.
As specialists in the evaluation of those products, we offer a large portfolio of specific assays as part as our Clinical trials Services.
Our clients will benefit from the development of the corresponding methods and information obtained during the non clinical phase of their project to easily and successfully manage the transition to clinical trial phases.
To support our central laboratory services, we provide our clients with an investigator’s manual detailing instructions regarding biological materials sampling, preparation and shipment.
GenoSafe applies the Good Clinical Practices (GCP) principles to the analysis of clinical trial samples.
Shedding of vector is mostly dependent on the dose and route of administration. The appropriate samples to be taken during clinical studies may vary and not always reflect the route of administration.
GenoSafe develops specific assays and performs the detection of the vector in a large variety of specimens such as blood/serum, saliva, tears, nasal secretions, buccal swabs/sputum, lung lavage, urine, faeces, semen and tissue biopsy (if possible).
Data allow estimating the extent of viral shedding and the likelihood and consequences of vector transmission. They should be used in the environmental risk assessment (ERA) presented as part of any future market authorization application.
One of the biggest challenges facing vector delivery in humans is the host immune response; the evaluation of the immunogenicity of both the vector and the transgene should be assessed.
GenoSafe offers a large variety of methods to monitor immune responses before and after administration of the product during clinical trials evaluating:
- Humoral immunity: measurement of neutralizing anti‐vector antibody titers and detection of anti‐vector circulating immunoglobulins
- Cell-mediated immunity
- Inflammatory response
- Cell surface marker detection assays by flow cytometry analysis
- RNA profiling of cells marker by RT-qPCR