Services Markets About Us Resource Center News & Events Careers
News Overview
Trade Shows
Webinars

Toxikon Corporation boosts biologics safety program services

Toxikon Corporation is pleased to announce the expansion of their immunotoxicology department's offerings.

Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function.

Christopher Brynczka, PhD., head of immunotoxicology, clinical and histology services at Toxikon, is excited about the company's new capabilities.

"This is an opportunity for Toxikon to promote the development of our Sponsor's 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," he added. 

"We know that drugs, and more and more frequently biologics drugs, have had an effect on the immune system," said Dr. Brynczka.

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

A study published last fall by the Journal of the American Medical Association confirms Dr. Brynczka's concerns, stating that almost one-quarter 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. 

Eleven percent of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.

The recent findings suggest the need for more extensive drug candidate research from the very beginning, well before it reaches approval and gets into the hands of the general public.

To meet increased demand for biologics research, Toxikon has added flow cytometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.

 "The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell," said Dr. Brynczka.

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

For more information about Toxikon's immunotoxicology, histology and pathology services, call (800) 458-4141 and ask to speak with a technical specialist or visit www.toxikon.com.