Bka7y72eritrmhi8wokw travail logo copie

GenoSafe

Evry, FR

GenoSafe® is a contract research organization which specializes in evaluating the quality, safety and efficacy of innovative biological products.

GenoSafe offers analytical development, testing and quality control.

We meet our clients’ specific needs by performing custom studies in strict compliance with regulatory requirements.

GenoSafe has not listed any services.

Analytical Validation
Price on request

As the development of your gene therapy or cell therapy product proceeds, GenoSafe will support your increasing needs for a specific assay method:

  • Development from scratch including a feasibility step
  • Optimization
  • Qualification for early phases
  • Validation according to ICH – Q2 (R1)
  • Transfer between... Show more »

As the development of your gene therapy or cell therapy product proceeds, GenoSafe will support your increasing needs for a specific assay method:

  • Development from scratch including a feasibility step
  • Optimization
  • Qualification for early phases
  • Validation according to ICH – Q2 (R1)
  • Transfer between laboratories

GenoSafe offers its clients an efficient and continuous approach ensuring the appropriate level of development at the right time according to regulatory guidelines.

Once a lead compound has been identified, the biopharmaceutical development is a long process including preclinical phases and clinical trials to obtain regulatory marketing approval. During this development a variety of analytical technologies are used to assess the characteristics of the product. Many of these methods must evolve into assays that will require validation for their final intended use. Validated test methods are necessary for full compliance with cGMP and GLP regulations.

« Show less
Cell culture
Rare Disease
Genomics
Cell-based assays
AAV
Drug Safety and Toxicology
lentivirus
lentivector
Immunoassays
Price on request

We perform immunoassay in research grade study, Preclinical (GLP) studies and Clinical (GCP) studies.

We follow-up of the immune response before/after the treatment and help for the Inclusion/Exclusion of patients.

We assess the Cellular response using :
ELISpot
Cytokine/chemokine measurement
ELISA, multiplex
Cell... Show more »

We perform immunoassay in research grade study, Preclinical (GLP) studies and Clinical (GCP) studies.

We follow-up of the immune response before/after the treatment and help for the Inclusion/Exclusion of patients.

We assess the Cellular response using :
ELISpot
Cytokine/chemokine measurement
ELISA, multiplex
Cell phenotype (flow cytometry)
Evaluation of T‐Cell responses

We assess the Humoral response using :
Anti-drug antibody response
Detection / titration of binding antibodies (ELISA, ECLa (MSD platform))
Detection / titration of neutralizing antibodies (cell-based or not)

« Show less
Immunoassays
Rare Disease
Immunofluorescence
immunohistochemistry
AAV
Chemiluminescent Immunoassay
Immunogenicity Studies
Drug Safety and Toxicology
lentivirus
lentivector
Immunochemistry
Stem Cells
GMO
In vitro Biologic Potency Testing
Price on request
Request a quote for more information about this service.
Rare Disease
AAV
Drug Safety and Toxicology
lentivirus
lentivector
In vivo Drug Efficacy Testing
Price on request
Request a quote for more information about this service.
Drug Discovery
Rare Disease
AAV
lentivirus
lentivector
Drug Formulation Evaluation
Price on request

Formulation analysis of AAV and Lenti

Formulation analysis of AAV and Lenti

« Show less
Rare Disease
AAV
Drug Safety and Toxicology
lentivirus
lentivector
Viral Assays
Price on request

Viral Shedding analysis (biodessimination)

Viral Shedding analysis (biodessimination)

« Show less
Rare Disease
AAV
Drug Safety and Toxicology
lentivirus
lentivector
RT-qPCR
Gene Expression Analysis
Price on request
Request a quote for more information about this service.
Rare Disease
AAV
lentivirus
lentivector
RT-qPCR
Protein Expression Profiling
Price on request
Request a quote for more information about this service.
Rare Disease
western blot
AAV
lentivirus
lentivector
Western blotting
Biodistribution Studies
Price on request

We advise investigator to define the parameters of the study

Develop and validate the qPCR methods

Perform the study in GLP conditions

Gene and protein expression assays (RT-qPCR, ELISA, W. Blot...)

We advise investigator to define the parameters of the study

Develop and validate the qPCR methods

Perform the study in GLP conditions

Gene and protein expression assays (RT-qPCR, ELISA, W. Blot...)

« Show less
Human
Mouse
Rat
Rare Disease
qPCR
body fluid
AAV
Drug Safety and Toxicology
lentivirus
lentivector
small animal
Stem Cells
Nonhuman Primate
Formulation Services
Price on request
Request a quote for more information about this service.
DNA Extraction and Purification
Price on request
Request a quote for more information about this service.
Bioanalytical Assays
Price on request

Bioanalytical Assays Services

Bioanalytical Assays Services

« Show less
Bioanalysis
Price on request

Bioanalysis Services

Bioanalysis Services

« Show less
In vitro Immunogenicity Assays
Price on request
Request a quote for more information about this service.
Transgenic Genotyping
Price on request
Request a quote for more information about this service.
Viral Vector Purification
Price on request

We perform quality testing of produced batches :

  • Physical titration
  • Viral particles
  • Viral genome
  • Infectious genomes
  • Detection of replication-competent viruses (RCAAV, RCL)

We perform quality testing of produced batches :

  • Physical titration
  • Viral particles
  • Viral genome
  • Infectious genomes
  • Detection of replication-competent viruses (RCAAV, RCL)
« Show less
Rare Disease
Drug Safety and Toxicology
Titration
Infectivity assay
RCAAV
RCL
RCV
replication competent viruses

GenoSafe has not received any ratings.

Be the first to endorse GenoSafe

Endorse this lab