Calvert Holdings

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Immunology – Immunotoxicology

The Immunology Department offers services for both efficacy testing and safety evaluation. We offer what we believe to be the most comprehensive immunology program within the industry.
Studies can be run to:

  • Assess and profile activity of test articles in models of inflammation, cancer and infectious disease. These studies range from screening of initial activity in relatively rapid in vivo assays to complex disease specific models.
  • Determine immunomodulation activity. Representative assays include Delayed Type Hypersensitivity Assays and various Immune Cell Assays.
  • Evaluate the test article for effects on blood compatibility (Hemolysis and Flocculation) and Antigenicity (Local Lymph Node and Anaphylaxis) assays and immunotoxicity.

Efficacy Testing

Screening models to assess basic activity or to select a lead candidate from a series of compounds are available in a wide range of therapeutic categories. Secondary disease models are utilized to characterize lead molecules, determine efficacy profiles and to address mechanistic questions.

Autoimmune/Inflammation Assays and Models
Screening assays such as the Carrageenan-Induced Paw Edema or the Delayed-Type Hypersensitivity Assay are used to determine initial activity or to screen leads. Animal models of disease such as Collagen-Induced Arthritis (Developing and Established), Experimental Autoimmune Encephalomyelitis (EAE), Inflammatory Bowel Disease (IBD), diabetes (Streptozocin, ob/ob and db/db Mouse Assays) and asthma are available to determine the compound’s effect oin the diseased animal.

Anti-cancer Models
The Nude Mouse Xenograft Model is run using a variety of dosing regimens. Nearly any cell line commercially available or proprietary can be used in this model, making it extremely useful for initial evaluation or lead optimization. Calvert has specific experience with prostate, breast, small cell lung, and melanoma lines.

Anti-infective Models

In vivo studies such as the Candida Albicans model for anti-fungal activity and rodent anti-bacterial models using a variety of bacterial strains are available.

Immunomodulation
Studies can be conducted to evaluate a test article’s impact on the immune system:

  • Cell-mediated Immunity
  • Humoral Immunity
  • Non-Specific Immunity

Safety Evaluation

In addition to immunotoxicology tests recommended by the US and European regulatory agencies, the Immunology Group has extensive experience with the Local Lymph Node Assay that was recommended by ICVAM as an alternative to the guinea pig sensitization studies. Calvert provides the safety studies listed below to address the major immune-based questions.

Antigenicity
The Local Lymph Node Assay, Systemic Anaphylaxis, Passive Cutaneous Anaphylaxis, and the Induction of Delayed-Type Hypersensitivity (DTH) Assays are commonly run. All assays are conducted to full GLP compliance.

Immunotoxicology
Calvert offers the full range of Immunotoxicology Studies recommended by the US and European regulatory agencies.

Blood Compatibility
Hemolysis and Flocculation Assays are conducted in blood/plasma/serum from humans, dogs, rats, and primates.

ELISA and RIA Assays

ELISA and RIA assays are performed in support of toxicology studies as well as clinical trials.
Calvert’s Immunology Group works with each sponsor to develop protocols to address all scientific issues. If our standard protocols are not appropriate, these can be modified or new methods developed to meet sponsors’ requirements. We are well recognized for our flexibility in designing Immunology programs.

Most Common Immunology Studies

Autoimmune/Inflammation Models
• Collagen-induced arthritis in mice
• Inflammatory bowel disease in mice or rats
• Experimental autoimmune encephalomyelitis in mice or rats
• Asthma in mice, rats, or guinea pigs
• Diabetes in mice or rats

Immunomodulation Assays
• Delayed-type hypersensitivity to OVA
• Delayed-type hypersensitivity to Oxazolone
• Antibody Response to KLH
• Natural killer cell assay
• Macophage phagocytosis assay

Antigenicity / Sensitization Assays
• Local lymph node assay
• Anaphylaxis in guinea pigs
• Passive cutaneous anaphylaxis in guinea pigs or rodents
• Delayed-type hypersensitivity in mice

Immunotoxicity Assays
• T-Dependent antibody response to KLH
• Delayed-type hypersensitivity assay
• Natural killer cell assay
• Macophage phagocytosis assay
• T and B cell enumeration
• Mitogen response assay
• Mixed lymphocyte response assay

Cancer Studies
• Mouse tumor models
• Xenograft models

Anti-Infective Studies
• Anti-fungal assays
• Anti-bacterial assays

Blood Compatibility Studies
• Hemolysis assay
• Flocculation assay

Miscellaneous
• Graph vs. host disease model
• Cytokine evaluation
• Hormone evaluation