Cell-based Assays (Cell Biology)

Overview

Cell-based assays are indispensable tools in biopharmaceutical research, pivotal for identifying and validating biological targets, screening lead compounds, and assessing preclinical safety. These assays provide vital data, ensuring the reliability and reproducibility of cell-based research and development activities.

Cell Culturing

Cell culturing involves the growth and maintenance of both adherent and suspension cells in laboratory settings. This process is fundamental in the pharmaceutical industry, supporting various downstream applications such as drug screening, toxicity testing, and biologics production.

Services Provided:

Manual Cell Counting:
Utilizing a Neubauer counting chamber with Trypan Blue staining for accurate assessment.
Automated Cell Counting:
Employing advanced cell counters for efficient and precise cell counting.
Viability Assessment:
Using XTT or MTT assays to measure metabolic activity, alongside staining techniques like neutral red or Giemsa to evaluate cellular morphology and integrity.

Growth-promoting Assays

Growth-promoting assays are critical for evaluating the efficacy of growth factors, cytokines, and other supplements in stimulating cell proliferation and viability. These tests provide essential insights into optimizing cell culture conditions for various applications, including research, bioprocessing, and clinical use.

Cytotoxicity Assays

Cytotoxicity assays determine the potential of substances to cause cell damage or death. These assays are crucial in assessing the biocompatibility of medical devices and other products.

For detailed information, refer to Biocompatibility / Cytotoxicity.

ELISA, capillary electrophoresis, determination of protein concentration

Skin Corrosion Test

The OECD Test Guideline 431 (TG 431) outlines the standard procedure for conducting skin corrosion tests. These tests assess the potential of substances to cause irreversible skin damage. We offer non-animal test methods, such as reconstructed human epidermis (RHE) models, which replicate the structural and functional characteristics of human skin. Substances are applied directly to the RHE models, and cell viability is assessed after a specified incubation period to categorize substances as corrosive or non-corrosive.

Skin Irritancy Testing

Skin irritancy testing ensures the safety and compliance of products under Good Manufacturing Practices (GMP). Following the guidelines set by the Organisation for Economic Co-operation and Development (OECD), these tests evaluate the potential adverse effects of products on the skin. The OECD Test Guideline 439 utilizes reconstructed human epidermis models to predict skin irritancy without animal testing.

Skin Sensitization Testing

Skin sensitization testing assesses the potential of products to induce allergic reactions upon contact with the skin. Adhering to OECD guidelines, these tests are critical for evaluating whether products contain substances that could trigger allergic responses. Methods include the OECD Test Guideline 442 (DPRA) and the KeratinoSens™ assay, both of which are non-animal testing methods that emphasize ethical practices.

Monocyte Activation Test (MAT)

The monocyte activation test (MAT) is used to detect pyrogens in pharmaceuticals, medical devices, and other products. This test involves exposing peripheral blood mononuclear cells (PBMCs) or a monocyte-based cell line to the test substance and measuring the release of pro-inflammatory cytokines such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). The MAT provides crucial data on the inflammatory response potential of products, aiding in the evaluation of their safety and quality.

Antibody Potency Assays

Antibody potency assays measure the effectiveness of antibodies in neutralizing target antigens or pathogens. These assays are essential in vaccine development, therapeutic antibody production, and assessing immune responses. They evaluate the capacity of antibodies to inhibit viral infection, toxin activity, or other biological functions, providing valuable data on antibody efficacy.