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GenoSafe

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Evry, FR

About GenoSafe

Type: Sole Proprietorship Size: 11-50 employees

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.

Our Services (16)


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Analytical Method 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 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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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 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)

Rare Disease Toxicology lentivector lentivirus Stem Cells GMO Immunoassays Immunofluorescence immunohistochemistry Immunogenicity Studies Immunochemistry Chemiluminescent Immunoassay Show 12 more tags Show less

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In vitro Biologic Potency Testing

Price on request
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Rare Disease Toxicology lentivector lentivirus

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In vivo Drug Efficacy Testing

Price on request
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Rare Disease Drug Discovery lentivector lentivirus

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Drug Formulation Evaluation

Price on request

Formulation analysis of AAV and Lenti

Rare Disease Toxicology lentivector lentivirus

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Viral Assays

Price on request

Viral Shedding analysis (biodessimination)

Rare Disease Toxicology RT-qPCR lentivirus lentivector

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Gene Expression Analysis

Price on request
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Rare Disease RT-qPCR lentivector lentivirus

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Protein Expression Profiling

Price on request
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Rare Disease western blot Western blotting lentivector lentivirus

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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...)

Rare Disease Toxicology qPCR lentivector lentivirus Stem Cells Biofluids Non-human primates (NHP) Mouse Human Rat Show 11 more tags Show less

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Formulation Services

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


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Bioanalysis

Price on request

Bioanalysis Services


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In vitro Immunogenicity Assays

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Transgenic Genotyping

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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)

Rare Disease Titration RCAAV RCL RCV replication competent viruses Infectivity assay Toxicology Show 8 more tags Show less

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Aymeric Huguenot

Business Development

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