FlowMetric

Preclinical Flow Cytometry Services

Flow Cytometry is a technology that is used in all aspects of pre-clinical development ranging from target selection and validation, to mechanism of action identification. Using cells in suspension, either from cell lines or from peripheral blood, we will quantitate the response on a per-cell basis. This is especially valuable in a setting where there are multiple phenotypes in the cell suspension and the biological response is different in each subset. This is possible with cells from multiple species including, but not limited to, human, non-human primates, rodents, and canine.

• Cell cycle analysis – Identification of cellular division stages.
• Cell proliferation – Identification and enumeration of cellular proliferation levels.
• Cell viability – Identification and numeration of dead (necrotic) and dying (apoptotic) cells.
• Cell phenotyping – Identification and enumeration of different types of cells in heterogeneous mixture.
• Cell signaling – Identification and enumeration of messaging within and between cell.
• Intracellular Cytokine Secretion (ICS) – Identification and enumeration of cells that are secreting factors (cytokines)

Clinical Flow Cytometry Services

Flow cytometry is routinely used in clinical laboratories for the diagnosis, prognosis and monitoring of disease. This leads to familiarity within the physician and nurse practitioner community on the use and collection of blood and other fluids for flow cytometry.

At FlowMetric, we have the ability to support partners in all phases of clinical development. A few of the applications include:

Phase 0 / Translational studies:

• Gain information and knowledge on the disease status
• Identify patient stratification criteria
• Identify biomarkers that are correlated with disease progression
• Isolate / sort relevant cells for nucleic acid extraction

Phase I – Safety, Tolerability and Efficacy studies

• Identify and quantitate activity of compound with different dosage levels (biomarker of activity)
• Identifying PK/PD dynamics in periphery and correlate it with clinical benefit
• Receptor Occupancy Assays

Phase II – Proof of Concept (disease)

• Identify and confirm biomarkers to designate responders vs. non-responders

Phase III / IV

• Generate data to support regulatory filings such as immune response to antigen post-treatment

Fluorescence activated cell sorting (FACS) is routinely used in pharmaceutical and biotechnology companies to isolate cells. Typically, the cells in suspension are “tagged” with fluorescent antibodies. This tag allows for pertinent cells to be identified and isolated into a liquid medium for further analysis.

With cell sorting At FlowMetric, we guide partners to achieve their biological goals, whether it is isolation of rare or abundant eukaryotic cell types. We have capabilities to isolate cells using up to 14 colors/16 parameters into 4 independent cell populations using aseptic or non-aseptic techniques.

At FlowMetric, we have capabilities to analyze up to 18 colors/20 parameters on a single cell simultaneously. We can interrogate intracellular and extracellular markers in the same panels. We regularly develop, validate and run pre-clinical/clinical samples for immunophenotyping in various species.

FlowMetric uses proven and tested methodologies for generating your next monoclonal antibody. As a one stop source for both your hybridoma production and screening needs using your in-house/vendor generated tissue, FlowMetric can perform any, and all of the following phases in our GxP laboratories:

Monoclonal Antibody Production

• Phase I: Fusion of Cells with the Appropriate Immortal Cell Line
• Phase II: Primary ELISA Screen
• Phase III: Confirmation Screens
• Phase IV: Sub-Cloning by Limiting Dilution Assay
• Phase V: Functional Screening & Biological Testing

The choice and flexibility are all yours! We can perform all these phases or apply only those required to fit your needs.

Post pre-clinical phase of drug development, the questions that arise are critical for each drug program. These questions directly relate to preparedness towards human clinical trials and enables the design of trials to allow adequate benefit-risk profiles for normal healthy volunteers as well as patients.

At FlowMetric, to answer some of the above questions for our partners, we perform flow cytometry assays that:

• Identify changes in the number and percentage of cell types before and after treatment (Cell Phenotype).
• Identify changes in biological (cellular) response before and after treatment by evaluating cell proliferation, cell signaling, cytokine secretion and other functional readouts.
• Identification of change in cellular signaling before and after treatment.

Flow Cytometry is a technology that is used in all aspects of pre-clinical development ranging from target selection and validation, to mechanism of action identification. Using cells in suspension, either from cell lines or from peripheral blood, we will quantitate the response on a per-cell basis. This is especially valuable in a setting where there are multiple phenotypes in the cell suspension and the biological response is different in each subset. This is possible with cells from multiple species including, but not limited to, human, non-human primates, rodents, and canine.

Some examples of ways that FlowMetric routinely performs pre-clinical assays using flow cytometry are:

• Cell cycle analysis – Identification of cellular division stages.
• Cell proliferation – Identification and enumeration of cellular proliferation levels.
• Cell viability – Identification and numeration of dead (necrotic) and dying (apoptotic) cells.
• Cell phenotyping – Identification and enumeration of different types of cells in heterogeneous mixture.
• Cell signaling – Identification and enumeration of messaging within and between cell.
• Intracellular Cytokine Secretion (ICS) – Identification and enumeration of cells that are secreting factors (cytokines)