The manufacturing of pharmaceuticals and biotherapeutics requires continual certification of every lot of product. Many products also require compendial potency or release bioassays, as well as routine sterility testing. Additionally, the quality and purity of water used in the production of many products must be assessed on a regular basis.
Compendial Bioassays are in vivo procedures to assess biotherapeutics.
Compendial Microbiology procedures are drawn from the USP and international pharmacopeias.
Toxin Testing services help assure the safety of therapeutic toxin products.
Sterility Testing ensures the microbiological quality of IV and parenteral drugs.
Water Testing assists in the validation and monitoring of DI and RO water systems for GMP production.