Calvert
has one of the most comprehensive programs within our industry and studies can
be performed:
|
-
Assess
and profile activity of test articles in models of inflammation, autoimmunity, cancer and
infectious disease. Studies range from screening of initial activity in
relatively rapid in vivo assays to complex disease specific models.
-
Determine
immunomodulation activity. 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 (Anaphylaxis) and hypersensitivity(Local Lymph
Node Assay).
-
Evaluate
the Immunotoxicity of a test article.
Efficacy
Testing
Services include several disease models of autoimmunity and inflammation.
These models can be used to evaluate the potential of a test article to modulate
the aberrant immune response, responsible for diseases such as rheumatoid
arthritis, asthma, inflammatory bowel disease, and multiple sclerosis.
Xenograft Studies
By using human tumors in nude mice, one is able to determine if a test article
will be effective against a human tumor in an in vivo model
Anti-Infective Studies
Anti microbial
activity of a test article can be assessed in a systemic infection model using a
number of different bacteria or fungi.
Safety Evaluation
In addition to the battery of immunotoxicology tests cited in the Guidance for Industry: Immunotoxicology Evaluation of Investigational New Drugs, our scientists perform the antigenicity studies
required for Japanese submission. They have years ofexperience with the Local
Lymph Node Assay, which has been recommended by ICVAM and is accepted by all regulatory agencies as an alternative to
guinea pig sensitization studies.
ELISA/RIA/ELISPOT
ELISA and RIA assays are performed in support of toxicology studies as well as
clinical trials.
|
