Charles River Clinical Services Receives Biosafety Level 2 Approval

April 23, 2009 – We are pleased to announce that our Clinical Services facility in Tacoma, WA, has been approved as a Biosafety Level 2 site for the conduct of research with biological products. 

A biosafety level designation is critical when handling investigational products, organisms, and viruses containing DNA molecules. With this approval, we will be able to further expand Clinical Services support for our clients by offering clinical studies using biologic agents associated with human disease that are rarely serious and for which preventative or therapeutic interventions are often available.

To achieve Biosafety Level 2 approval, our facility had to meet a number of requirements, including a facility review by an institutional biosafety committee and study review by the National Institute of Health Recombinant DNA Committee; additional training on a study-by-study basis relative to the handling, preparation, and delivery of the investigational product; and special protective equipment and precautions for personnel during the administration of the biological product.

In addition, staff responsible for handling the biological product during preparation and delivery must meet certain physical criteria to avoid unnecessary exposure, and studies involving those products will require extra effort to educate volunteers on the difference between a biologic and an investigational drug.

We are excited to extend this new level of support to our clients as one more way to help them accelerate their drug development. For more information about our full portfolio of Clinical Services, click here.