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 Clinical Research Organizations

As specialists in the evaluation of gene and cells therapies products, we offer a large portfolio of specific assays (Virology assays, immunology assays) as part as our Clinical trials Services for Follow-up of research subjects.

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.

AAV, Lentivirus, Plasmid, CRISPR, CarT Cells

Main services

Immunogenicity testing: Cellular and Humoral responses

Viral Shedding and Biodissemination analysis

Potency and Gene expression (mRNA and protein) analysis

Detection of RCV in transduced cells from patients

 

Compounds

In vivo Gene Therapy

AAV vectors

Non integrative Lentivirus vectors

Non vectorised DNA (plasmid)

Ex vivo Gene Therapy (autologous or allogenic)

Lentivirus vectors

Retrovirus vectors

Car-T cells

CRISPER 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. 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.

Focus : Immunomonitoring

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 using direct assays or cell based assay.