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Cytotoxicity Testing

Cytotoxicity testing is widely applied in pharmaceutical industry to study the toxicity of compounds to cellular systems. Cytotoxicity testing provides a rapid, sensitive and effective method to quantify the harmful dose range of a compound and to assess the cytotoxic potential of a device or material to inhibit cell growth or cause cell death. In addition, cytotoxicity testing can be used for quality control purposes for batch release testing of raw materials or manufactured drug products. BOC Sciences can select the appropriate cytotoxicity testing method based on the nature of the sample to be evaluated.

Schematic of a  cytotoxicity testing microsystem. Figure 1. Schematic of a cytotoxicity testing microsystem. (Garcia-Hernando, M.; Benito-Lopez, F. et al.2020)

Our Services

To make it easier and better for researchers, BOC Sciences provides cytotoxicity testing service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. Aiming to qualitatively or quantitatively determine the toxicity to cells of compounds, BOC Sciences offers qualitative cytotoxicity testings such as the direct contact test, the indirect contact agar diffusion test, and the MEM elution test. In addition, we offer a very sensitive quantitative cytotoxicity test, the MTT test:

  • Direct contact method

We recommend the direct contact method for low and high density materials. Our direct contact strategy is the agarose overlay (agarose diffusion) method

  • Agarose diffusion method

In the agarose diffusion process, our team incubates cells, agar and test samples for more than 24 hours, and then examines them under a microscope to determine the severity of toxicity to cells based on a 0-4 grading scheme

  • MEM elution method

Extractables and leachables from the test article are applied to the cells, and then the test article is incubated with a liquid termed the extraction vehicle. Finally, cytotoxicity is determined based on the condition of the cells, using a grading system from 0 to 4 which is correlated the observed cytotoxic affect

  • MTT Assay

The MTT assay is a quantitative cytotoxicity assay using a dye called 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (abbreviated to MTT). Our expert teams apply extracts of the test articles for MTT analysis. Finally, the samples are compared to controls to determine the percentage of surviving cells

Cytotoxicity  assessment microsystems with fluorescent label based detection. Figure 2. Cytotoxicity assessment microsystems with fluorescent label based detection. (Garcia-Hernando, M.; Benito-Lopez, F. et al.2020)

In Vitro Toxicity Screening Services

Our in vitro testing using primary cells allows for rapid screening of new chemical entities with serious toxicological consequences.

  • Cell viability (luminescence-based ATP assay)
  • Cell growth and survival (MTT/WST-1 metabolism)
  • Apoptosis
  • Oxidative stress

Cytotoxicity Testing Establishment

  1. First, we explore and optimize various parameters that might be involved in the experiment. The experimental parameters considered are: cell lot number, cell density, incubation time, number of dosing, MTT amount, MTT incubation time, DMSO lysis time (oscillation time), etc.
  2. After the cytotoxicity assay method is stabilized, the standard deviation of absorbance of each well, the coefficient of variation and the standard deviation of inhibition rate of each well could be controlled at a very low level, indicating that the experimental protocol is stable, with good reproducibility.

Cytotoxicity Testing Quality Evaluation Index

  • Average OD: The larger the OD value, the higher the number of cells
  • Standard deviation between the OD values of multiple wells (STDEV): The larger the standard deviation, the greater the non-parallelism between the multiple wells and the greater the operational error
  • Coefficient of variation (CV) between OD values: An indicator of the dispersion of OD values between wells
  • Survival rate (%Viability): The greater the cell survival rate, the small cytotoxic effect of the drug
  • Standard deviation of survival (%STDEV): This value reflects the standard deviation of survival if each replicate is used as a separate experiment

Microsystems for  label-free cytotoxicity testing. Figure 3. Microsystems for label-free cytotoxicity testing. (Garcia-Hernando, M.; Benito-Lopez, F. et al.2020)

Why choose BOC Sciences?

Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:

  • Comprehensive, integrated CMC services with a flexible service model that grows with your programs
  • Knowledgeable industry experts who deliver scalable, actionable insights
  • World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
  • Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
  • A focus on risk management that is designed to ensure completion of your technical goals

BOC Sciences provides professional, rapid and high-quality services of cytotoxicity testing at competitive prices for global customers. Personalized and customized services of cytotoxicity testing can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!

Reference

  1. Garcia-Hernando, M.; Benito-Lopez, F. et al. Advances in Microtechnology for Improved Cytotoxicity Assessment. Frontiers in Materials. 2020. 7.

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