Service Focus Cell Based Assays

Cell Based Assays
IBR Inc. has over 10 years of experience in method development and validation for a wide variety of cell based assays applied in different fields of drug development. Our experienced technical team provides a bespoke service for our clients and will accommodate specific timelines and budgets.

IBR Inc. offer custom method development and GLP validation of assays for analysing the influence of biologics or small molecules on cells (Cell Proliferation, Migration, Adhesion, Biomarker expression).

Leukocyte Isolation
IBR Inc. provides Leukocyte isolation from a wide variety of body fluids (e.g. blood, urine and cerebrospinal fluid) which represents a necessary prerequisite to study leukocyte function in preclinical and clinical research. Techniques include buoyant density centrifugation methods (Ficoll, Percoll and Metrizoate) and magnetic bead separation. Purified leukocytes are characterised by flow cytofluorometry (FACS), ELISA and cell based functional assays analyzing:

• Cell proliferation
• Apoptosis
• Cytotoxicity
• Oxidative burst
• Enzyme release
• Intracellular cytokines (e.g. IFN-gamma, IL-2, TNF-alpha)
• Leukocyte adherence
• Leukocyte transendothelial migration
• Leukocyte chemotaxis
• Opsonophagocytosis and bacterial killing assays

Cell Residues Tests
• Host Cell Proteins
Generic and Host Cell Specific ELISA: Method Development, Validation, Sample Analysis
2D Gel Western blot

• Host Cell DNA
Proprietary method to cover the New Draft FDA guideline on quantitation of residual DNA (>200bp) according to size in final vaccine drug products and procedural samples

• Strain-specific quantitative PCRs

Cell Based Immune Response
• T-cell immune response after vaccination
• B-cell immune response after vaccination
• Clinical studies: Cellular and humeral immunology and functional in vitro tests human PBMCs (Isolation, Proliferation, Cytotoxicity, Phenotyping, Cytokine release, Gene expression) Neutralising Antibodies testing

Immune Cell Function Tests
• Compounds that are not myelotoxic may affect lymphocytes as primary effectors and regulators of acquired immunity. The following test systems serve as preliminary evaluation of modifications on the acquired immunity in terms of lymphocyte function and proliferation.

Test system 1: Influence of a compound on cytokine production of whole blood samples after stimulation with mitogens (e.g. PHA).

Test system 2: Influence of a compound on proliferation of lymphocytes and monocytes after polyclonal activation.

In Vivo Test Systems for Detailed Evaluation of Immunotoxic Effects
• Quantitation of specific and total IgG, IgM, IgA
• Lymphocyte phenotyping (FACS)
• T- and NK cell function
• Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)
• Cytotoxic T Cell(CTC) assays
• Cytokine profiling
• Immunehistochemistry

Cell Response Biomarker Expression after Stimulation
Biomarkers play an integral part in all phases of the drug development process in facilitating development of effective and safe drugs. Biomarkers can be utilized in short term clinical studies primarily within the first two phases of clinical trials as well as preclinical safety studies and toxicology studies to identify and source the appropriate drug candidates with safety concerns and potential toxicity.

IBR Inc. specializes in developing and validating targeted assays to track in vivo activity in the appropriate drug candidate. IBR Inc. focuses its expertise in monitoring and analyzing several specific molecular readouts simultaneously which can include but not limited to cell surface antigens or mediators of inflammation. Using the latest in-house knowledge from our panel of experts the progress of the target indication and the effects of the treatment can be analyzed in real time and in a quantitative manner providing the best possible information to allow our clients to make informed decisions. Our team specializes in the latest techniques in molecular biomarker studies which include ELISA, HPLC, Cytofluorometry (FACS) and quantitative RT-PCR techniques.

For more information or to discuss service focus cell based assays please contact us directly.