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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.

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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.

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Cell culture
Genomics
Cell-based assays
AAV
Rare Disease
Drug Safety and Toxicology
lentivirus
lentivector
Viral Production and Assays
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)
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Rare Disease
Drug Safety and Toxicology
Titration
Infectivity assay
RCAAV
RCL
RCV
replication competent viruses
Immunoassay Services
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)

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

Formulation analysis of AAV and Lenti

Formulation analysis of AAV and Lenti

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

Viral Shedding analysis (biodessimination)

Viral Shedding analysis (biodessimination)

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

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Human
Mouse
Rat
qPCR
body fluid
AAV
Rare Disease
Drug Safety and Toxicology
lentivirus
lentivector
small animal
Non-human primates
Stem Cells
Cell Line Authentication
Price on request

By Immunohistochemistry or RT-qPCR

By Immunohistochemistry or RT-qPCR

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immunohistochemistry
Rare Disease
Drug Safety and Toxicology
RT-qPCR
Genotyping Services
Price on request
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Formulation Services
Price on request
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Immunoassays
Price on request
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DNA Extraction and Purification
Price on request
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Bioanalytical Assays
Price on request

Bioanalytical Assays Services

Bioanalytical Assays Services

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Bioanalysis
Price on request

Bioanalysis Services

Bioanalysis Services

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In vitro Immunogenicity Assays
Price on request
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Transgenic Genotyping
Price on request
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