Rapid microbiological methods (RMMs) encompass any technology that allows a user to get microbiology results faster compared to traditional methods. RMMs were first commercialized in the 1990’s, but the pharmaceutical and biopharmaceutical industries have been slow to embrace these faster technologies. Why? Historically, the challenges in implementing RMMs have been in regulatory acceptance and the perceived cost of implementation.
Horseshoe crabs, which are native to parts of United States and Asia, contain a unique clotting agent in their blood that is used to make an important test reagent: Limulus Amoebocyte Lysate (LAL).
Releasing a vaccine to the public is a complex process. Quality control testing is critical at every stage, from initial development to full-scale production, to make sure vaccines are as safe as possible.
