Services for the Evaluation of Product Toxicity and Safety
ImQuest BioSciences utilizes the ToxiSENS platform to assess product safety through a variety of in vitro and ex vivo assays which quantify the toxicity and off-target effects of potential drug products on host cells and tissues. These in vitro and ex vivo assays are utilized to identify potential safety and development problems which should be the focus of animal safety and toxicology evaluations, and to provide a clear focused rationale for the continued or discontinued development of a therapeutic or prevention product. Many aspects of compound toxicity are affected by the pharmaceutical properties and formulation of the product, thus, ToxiSENS evaluations are performed in parallel with our PharmaSENS platform studies to assist with the development of a drug delivery strategy which will yield enhanced efficacy and reduced toxicity.
ImQuest BioScience's in vitro and ex vivo toxicology capabilities include the following:
- In vitro cytotoxicity in established and primary cell types
- Cell viability
- Macromolecular synthesis
- Membrane integrity
- Cell proliferation
- Oxidative stress
- Flow Cytometric Assays
- In Vitro Drug Permeability Evaluation
- In Vitro Metabolism
- Drug-drug interactions
- Genomic Toxicology Analysis
- Pharmacokinetics and pharmacodynamics
To view our white paper on In Vitro Toxicology, click on the link below.
Support of Pharmacokinetic and Pharmacodynamic Evaluations in Animals and Humans
The development of biologic products for infectious disease, cancer or any other human health condition requires the development of GLP-compliant immuno- and bio-assays to quantify the pharmacokinetic profile of the subject product. In addition, it is important to understand the immunogenicity of the product when provided to animals or humans and if the immunogenicity results in neutralization of the product. ImQuest BioSciences has the capability and experience to develop, qualify, validate and perform GLP-compliant immunoassays to support the evaluation of biologics through animal safety/toxicology and human clinical trials.
ImQuest BioSciences performs the following immunoassay services for the development of biologic products:
- Technology transfer of existing assays or development of ELISA or cell-based immunoassays for the detection of biologic products.
- Feasibility evaluation and continued assay development prior to GLP validation.
- GLP validation, including accuracy/precision, selectivity, reproducibility, sensitivity and stability, in order to demonstrate the robustness of the assays to provide rigorous and quantitative data.
- Evaluation of biological samples from small and large animal safety toxicology studies and human clinical trials.
- Species adaptation of the assay using appropriate biological matrices.
Additional supportive services as part of the ImQuest SUCCESS platform:
- PharmaSENS-pharmaceutical product characterization services
- ViroSENS-antiviral product development services
- MicroSENS-antimicrobial product development services
- PrevSENS-antimicrobial prevention product development services
- FemSENS-women's health product development services