Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
Manufacture Bioprocessing - Upstream & Downstream, Bioprocessing - Single Use Systems

A Biosafety Revolution

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.

Figure 1: Lot release testing steps required for monoclonal antibody production.

Read the full article now

Log in or register to read this article in full and gain access to The Medicine Maker’s entire content archive. It’s FREE and always will be!

Login

Or register now - it’s free and always will be!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine
Register

Or Login via Social Media

By clicking on any of the above social media links, you are agreeing to our Privacy Notice.

About the Authors

Afshin Sohrabi

Afshin Sohrabi, Ph.D, is Head of Near Real Time Testing Lab, focusing on the BioReliance® biosafety portfolio at Merck.


Audrey Chang

Audrey Chang, Ph.D, is Head of PSS R&D, focusing on the BioReliance® biosafety portfolio at Merck.


Martin Wisher

Martin Wisher is Senior Regulatory Consultant. He focuses on the BioReliance® biosafety portfolio at Merck.

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register