EAGAN, MN – April 20, 2007 – Biothera now has the capability to conduct research under Good Laboratory Practice (GLP) guidelines in compliance with a detailed quality assurance program from the U.S. Food and Drug Administration, the company announced today.
Good Laboratory Practice for Nonclinical Laboratory Studies (FDA 21 CFR 58) addresses the facilities, processes and conditions under which research is planned, conducted and analyzed to ensure that the collected data is valid and of high quality.
“Few biotech companies the size of Biothera achieve GLP status,” said Daniel K. Conners, Biothera chairman and founder. “Conducting research under the FDA’s quality assurance guidelines enhances the integrity and credibility of our data.”
The company initiated its GLP program to conduct pharmacokinetic research that measures the profile of its drug candidate, Imprime PGGTM, in animals and test subjects over time.
The adoption of GLP standards is part of a comprehensive quality assurance program that Biothera instituted 12 months ago. The company’s Quality Assurance department oversees both nonclinical research and manufacturing of pharmaceutical and food-grade ingredients.
About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals that engage the immune system to fight cancer. In addition, Biothera manufactures and markets food-grade ingredients that support healthy immune function to the nutritional supplement, functional food, cosmetic and animal nutrition markets.
Biothera, the Immune Health Company