Widely known as the product generally used by ageing and affluent celebrities to remove wrinkles or for other cosmetic applications, BOTOX is in fact an important medicine that over the last 15 years of clinical use has helped millions of patients with serious medical conditions worldwide. Pharmaceutical manufacturers using Clostridium botulinum toxin (BOTOX ) in drugs are required by the Food and Drug Administration (FDA) in the United States and by other worldwide health regulatory agencies to protect patients and consumers by assuring product safety and efficacy through animal testing and other methods.
In a recent study (Biochemica 4/2008, in print), James O´Connell et.al. from ACEA Biosciences in San Diego have used the label-free, real time xCELLigence cell analyzer system to test biological effects of botulinum toxin on live cells. Currently, there is no in vitro assay approved by the USFDA and other international regulatory bodies for the release of Botulinum Toxin A. The preliminary results indicated that the xCELLigence System was able to detect specific biological effects on two CNS-derived cell lines - A172 glioblastoma cell line and SH-SY5Y neuroblastoma cell line. Additional cell lines are currently being evaluated.
According to Dr. O’Connell, the xCELLigence System was also used to identify closely related Clostidrium difficile toxins A and B directly from stool samples using cell culture and specific toxin neutralization with highly specific toxin A and B antibodies. “The test as performed with the xCELLigence System is extremely sensitive and is highly specific. Our preliminary results with botulinum toxin indicate the possibility of replacing the animal test for BOTOX with a highly sensitive and specific real time, label free cell-based assay on xCELLigence.
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Roche Applied Science.
