regulatory compliance 

Representatives from Charles River Biopharmaceutical Services will be attending this event and would be delighted to discuss how our range of services can meet the needs of your development program. Please stop by our booth #B3 to learn more.

The theme of this year’s annual meeting of The Canadian Association for Laboratory Animal Science (CALAS) is “The Heart of the Matter.” In addition, to an exhibit, Charles River is pleased to be participating in this year’s meeting with three posters, a technical presentation and a workshop.

There are several guidance documents which highlight the assays needed to measure immunosuppression, however guidelines for monitoring immunostimulation are lacking. The presentations will focus on assays used to measure immunostimulation for biologics, biosimilars and vaccines. With emphasis on immunogenicity testing, Elispot and cytokine assessments. The presentations will also review how we conduct these safety (toxicity) studies, what makes reproduction and developmental safety (toxicity) study designs unique and different from general safety (toxicity) studies. Why we need to address the issues of male and female fertility, pregnancy, development of offspring for molecules and vaccines that intended for life threatening diseases and when are expected to conduct these evaluations.

This seminar will provide an overview on the basics of LAL test technology with in-depth analysis on the types of test methodology available and a focus on problems sometimes encountered in endotoxin testing, including resolving interference issues.