Regulations— External Information

Welcome to ImmunoTox, Inc.

General Overview of Immunological Capabilities

I. Recommended Immune Evaluation for a Test Compound to Meet FDA or EPA Immunotoxicological Requirements

Humoral Immunity (T-dependent Antibody Response):

  • Spleen IgM AFC Response to sRBC, either Plaque Assay or ELISA
  • Keyhole Limpet Hemocyanin, ELISA or ELISPOT

Cell-Mediated Immunity:

  • Mixed Leukocyte Response (mouse)
  • Anti-CD3 (rats), Anti-CD3 assay can also be conducted in the mouse

Innate Immunity:

  • Natural Killer Cell Activity
  • Poly IC-Induced Natural Killer Cell Activity

Phenotypic Analysis:

  • Spleen Cell Phenotyping (B cells, Total T cell, and T Cell subsets, Natural Killer Cells and Macrophages/Monocytes)
  • Other cell populations and activation markers can be added at the Sponsor's request
  • Phenotypic analysis can also be conducted on the thymus, lymph nodes, and peripheral blood

Macrophage Function (MPS):

  • While it is not normally recommended for a standard evaluation, if the compound is known to target macrophages then the functional activity of the mononuclear phagocytic system (MPS), previously known as the reticuloendothelial system (RES), can be evaluated in the whole animal.

II. Additional Immunological Capabilities

Other Functional Assays:

  • Mixed Leukocyte Response (MLR)
  • Cytotoxic T-Cell Response (CTL)
  • Anti-CD3 Mediated Proliferation
  • Phagocytose Assays
  • Chemotaxic Assays
  • Superoxide Production Assays
  • Nitric Oxide Production Assays
  • Complement System Assays

Host Resistance Assays:

  • Listeria monocytogenes
  • Streptococcus pneumoniae
  • B16Fl0 Melanoma Tumor Model
  • PYB6 Tumor Model
  • Plasmodium Yoelli

Cytokine Evaluations by Multiplex Methodology:

  • Humans
  • Animals

ELISA Procedures:

  • Total Serum Antibody Concentrations
  • Antigen Specific Antibody Concentrations
  • In Vivo and In Vitro Cytokine Levels

Flow Cytometry Phenotypic Analysis of Tissues or Peripheral Blood for the Following:

  • Human
  • Mouse
  • Rat
  • Monkey

Bone Marrow Evaluation:

  • Cell Number
  • Colony-Forming Units-E
  • Colony-Forming Units-GM
  • Colony-Forming Units-M

Mitogen Stimulation Proliferative Assays:

  • Con A
  • LPS
  • PHA

Radioactivity and Chemical Illuminescence Assays as Requested by the Sponsor

Hypersensitivity Models:

  • Contact Hypersensitivity:
    • Local Lymph Node Assay (LLNA)
    • Mouse Ear Swelling Test (MEST)
    • Primary Irritancy Assay (IA)

  • Respiratory Hypersensitivity:
    • lgE Respiratory Assay (Kimber Model)
    • IL -4 Determination:
      Protein by ELISA
      mRNA Message by RNAse Protection Assay
    • IL-13 Determination:
      Protein by ELISA
      mRNA Message by RNAse Protection Assay
  • Protein Hypersensitivity:
    • Mouse Intranasal Test (MINT)
      Antigen Specific IgG1 and IgE Antibody Levels Determined by ELISA
Antigen Specific Cytokine Profile:
  • ELISPOT Technology
    • Mouse
    • Rat
    • Monkey
    • Human
Autoimmune Models:
  • Brown Norway Rat
    Chemical or drug induction model
  • NZBxW and MRL Mouse Models
    Exacerbation model

Molecular Biology Techniques:
are available through collaboration with researchers at the Medical College of Virginia Campus of Virginia Commonwealth University (MCV/VCU).


BACK TO TOP

ImmunoTox, Inc.
Virginia Bio•Technology Research Park
800 East Leigh Street, Suite 209
Richmond, VA 23219-1534
Tel (804) 828-6880 • Fax (804) 828-6881
© 2008 ImmunoTox, Inc. All Rights Reserved. No Reproduction without expressed written permission.
Problems with this page? Questions about this site? Contact the Webmaster
ImmunoTox and its trademark are registered in U.S. Patent and Trademark Office.