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Toxikon Boosts Biologics Safety Program Services

Toxikon Corporation (Booth 1161) has expanded the offerings in its immunotoxicology department. To meet increased demand for biologics research, Toxikon has added flow cyctometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.

Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, remarked, “This is an opportunity for Toxikon to promote the development of our sponsors’ drugs and medical devices,” said Dr. Brynczka. “If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary.”

Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function. “The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell,” said Dr. Brynczka.

A study published last fall by the Journal of the American Medical Association stated that almost 25% of biologic drugs approved in the U.S. and Europe since 1995 have been at the forefront of at least one safety-related regulatory action in the decade since initial market approval, while 11% of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.

While all newly developed drugs carry risks, said a Toxikon statement, biologics are in a special class because they are derived from biological sources, including antibodies, enzymes and hormones.

The new equipment is just one of several additions Toxikon has added to its immunotoxicology department, offering everything from quantitation of splenic B and T cells to a full battery of host resistance models.

Visit Toxikon Corporation at Booth 1161!