A Biosafety Revolution
Biopharma manufacturers have been using the same assays for viral safety testing for decades, but new analytical technologies and molecular approaches offer a faster and more reliable approach. Until the next revolution…
Afshin Sohrabi, Audrey Chang, Martin Wisher |
sponsored by MilliporeSigma
Monoclonal antibodies and other biopharmaceutical products, as well as their manufacturing processes, are inherently at risk of viral contamination, making viral safety testing critical. Viral safety testing is mandated by regulators worldwide, and although technologies for biomanufacturing have rapidly advanced, viral testing methods remain largely the same today as they were thirty years ago. Traditional virus detection approaches – cell-based assays – have served the biopharma industry very well over the years, but they have limitations; for example, some assays have long turn around times such as 28 days. In addition, although cell-based assays can detect contaminants, they generally cannot directly identify them and it can be slow to obtain results.
Albert Einstein once said, “Once we accept our limits, we go beyond them.” In an age where speed is the key to success, we believe it is time to accept the limitations of traditional testing and to focus on newer technologies that focus on speed, sensitivity and reliability. Faster assay results will lead to more rapid batch disposition, reduced interruption of processing, and also meet the needs of more intensified processing – a key capability given the increasing interest that manufacturers are paying to continuous manufacturing strategies.
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