CS Analytical Laboratory, the only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services for drug product and medical device package systems, has been granted Bio-Safety Level – 2 (BSL-2) certification by the U.S. Department of Agriculture. In preparation for the required inspection, CS Analytical implemented a number of physical improvements and quality system improvements for the proper handling of potentially biohazardous materials and products. With this approval, the company is authorized to receive Organisms and Vectors (OV) Permits, expanding service offerings to live attenuated virus vaccines and viral vector platforms.  

“Many modern medicines rely on a biologic and genetic materials, such as proteins, viral vectors, and DNA/mRNA, rather than pharmaceutical compounds. Products in this class can be subject to unique regulation and require special handling,” said Brandon Zurawlow, Chief Scientific Officer. “As a USDA-approved BSL-2 laboratory, the CS Analytical Team can expand to assist clients commercializing traditional attenuated virus, cutting-edge viral vector vaccines, and other novel products in a safe and effective manner.”

Although acquired for CS Analytical’s use case as a container and package testing laboratory, the procedural and safety standards of BSL-2 laboratories prepares for safe handling infectious agents such as HIV, equine encephalitis viruses, and Staphylococcus aureus (staph infections). As such, a number of safety precautions must be in place inclusive of specialized equipment.