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In Vitro Cytotoxicity Testing for Microspheres & Microneedles

In Vitro Cytotoxicity Testing

The in vitro cytotoxicity test is universal and can be applied to the evaluation of various biological materials. The in vitro cell culture technique allows the detection of cell growth inhibition, functional changes, cell lysis, death or other toxic reactions that occur after microspheres and microneedles come into contact with cells.

Methods for In Vitro Cytotoxicity Testing of Microspheres & Microneedles

In vitro cytotoxicity test methods do not prescribe a single test method, but rather a test protocol that requires judgment in a series of test steps to select the most appropriate test, which is divided into three main categories: extract test, direct contact test and indirect contact test. The selection of in vitro cytotoxicity test methods should take into account the principle of the test, sensitivity, optionality, quantifiability, reproducibility, applicability of test materials and limitations. For example, the leachate method is suitable for detecting the toxicity of lysates; the direct contact method has the highest sensitivity to the cytotoxicity of materials and can detect weak cytotoxicity of materials, the agar diffusion test in the indirect contact method is suitable for screening large quantities of toxic materials, and the filter membrane diffusion method is suitable for the evaluation of small molecular weight toxic materials. The test method should be selected correctly according to the physical and chemical properties of the test material itself, the strength of the toxic effect and its use.

How to Perform In Vitro Release Testing and Evaluation

Selection of cell lines and culture media

Preference should be given to established cell lines and obtained from approved reservoirs. Only cells free of mycoplasma contamination should be used for the test. Primary cultured cells should be tested for the presence of mycoplasma before use. When using lyophilized cells, if cell protectants such as dimethyl sulfoxide or glycerol are present, the protectants should be removed and the cells should be passaged at least once before use. When subculturing cells, remove and resuspend cells by enzymatic dispersion or mechanical dispersion methods appropriate for the cell line. The medium should be sterile and serum-containing or serum-free medium should meet the growth requirements of the selected cell line. The medium may contain antibiotics that have no adverse effect on the test, and the storage conditions of the medium should be validated before it is stored under these conditions.

In Vitro Cytotoxicity Testing

CD Formulation can provide in vitro cytotoxicity testing, and we produce reports that are qualified and regulated by industry expertise.

In Vitro Cytotoxicity Evaluation

  • Cell viability

Cell viability is the simplest and most direct indicator of cell growth status.

  • Cell morphology

Cell morphology is the study of the microstructure and submicrostructure of cells and their components, including the structure of biomolecules that express cellular life phenomena. The toxic effects of the test drug on cells in vitro can be directly reflected in the cell morphology structure, causing abnormalities in the cell morphology structure, therefore, the cell morphology test is also one of the most intuitive evaluation indicators to reflect the toxicity of cells in vitro.

  • Cell cycle and apoptosis

Cell cycle and apoptosis are both fundamental phenomena of life and are essential measures to maintain the dynamic balance of cell population in the body, in embryonic development, hematopoiesis, maturation of the immune system and maintenance of normal tissues and organs. They play an important role in embryonic development, hematopoiesis, maturation of the immune system, maintenance of cellular constancy and growth balance of normal tissues and organs, and even aging of the organism, and are also the basic principles of drug-induced toxicity.

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Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.
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