New Monoclonal Antibody Support Offered by Charles River
August 20, 2009 – Monoclonal antibodies (mAbs) are a promising innovation in the field of biological therapeutics, and Charles River has created an optimized approach for their preclinical development based on our vast experience with this class of molecules. Now, based on more than two years of exploratory study designs, we have combined safety pharmacology and toxicology into a single general toxicology study, without compromising either set of end points.
This new offering will help our clients streamline their biological programs and save valuable resources in their quest for new therapeutics.
Due to the specificity and size of mAbs, adverse side effects on vital organ systems are less likely than with small molecules. For example, mAbs cannot cross the cell membrane to affect the inner core of the hERG channel in the cardiovascular system. As a result, in vitro assays for hERG interactions do not typically need to be conducted as part of the preclinical risk assessment for prolongation of the corrected QT (QTc) interval.
In addition, mAbs have a generally long half-life, making the traditional acute single-dose cardiovascular safety pharmacology study for QTc risk assessment of small molecules similarly unnecessary.
This cost-effective approach also eliminates unnecessary animal use in a single acute dose study, allowing for a better continuity of data, as well as supporting the requirements of humane care and satisfying regulatory requirements.
With recent scientific literature validating and highlighting the many potential benefits of mAbs, Charles River is proud to offer this service to our clients. For more information about this services and our other preclinical services, please visit the Preclinical Services section of our website.