Clinical Development

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 CROs.

As experts in the evaluation of gene and cell therapy products, we offer a large portfolio of specific assays in different domains (Virological assays, immunological assays) for the follow-up of patients enrolled in clinical trials.

Our clients can benefit from the development of the methods and information obtained during the non clinical phase of their project in order to succeed and accelerate the transition to the clinical trial.

We provide our clients with an investigator’s manual detailing instructions regarding biological material sampling, preparation and shipment.

GenoSafe applies the Good Clinical Practices (GCP) principles to the analysis of clinical trial samples.

Our Main services

Immunogenicity testing: Cellular and Humoral responses

Viral Shedding and Biodissemination analysis

Potency and Gene expression (mRNA and protein) analyses

Detection of RCV in transduced cells from patients

Our areas of expertise

In vivo Gene Therapy

Adeno-Associated Viral vectors (AAV)

Non-integrative Lentiviral vectors

Non-vectorized DNA (plasmid)

Ex vivo Gene Therapy (autologous or allogenic)

Lentiviral vectors

Retroviral vectors

Car-T cells

Cells with CRISPR modifications

Plasmid

Somatic Cell therapy

Stem Cells (Differenciated)

Autologous modified cells

Focus : Shedding

Shedding of vector is mostly dependent on the dose and route of administration.

GenoSafe develops and performs specific assays to detect the vector in a large variety of specimens such as blood/serum, saliva, tears, nasal secretions, buccal swabs/sputum, lung lavage, urine, feces, semen and tissue biopsy (when possible).

The generated data must be used for environmental risk assessment (ERA), which forms an integral part of the application for marketing authorization.

Focus : Immunomonitoring

One of the most important challenges related to the delivery of vectors in humans is the immune response induced by the gene therapy vector or the transgene product.

GenoSafe offers a large variety of methods for the follow-up of patients enrolled in clinical trials to monitor immune responses (humoral, cellular and inflammatory) before and post-treatment.