Death to Cleanrooms
Cleanrooms can be eliminated for biopharmaceutical manufacturing, if the goal of 100% closed processing can be achieved. This bold statement is from a Pharma’s Almanac article by Dr. Marc Pelletier, an internationally-recognized expert on biopharmaceutical manufacturing.
“Closed processing can be achieved either by designing closed equipment or placing the open process inside a closed system such as an isolator. Whether using traditional stainless-steel tanks that are functionally closed by CIP and SIP or using single-use (SU) systems that are closed by gamma irradiation or by housing a process within a properly conditioned isolator, these options all represent a more cost-effective strategy that represents much lower risk to the patient.”
A properly conditioned isolator is one that is not only aseptic for cell processing, but is designed from the outset for the needs of cells used for production of biologics. It protects functionally closed systems by providing additional barrier to the environment during steps when the cultures or product have to be accessed.
“A closed system is validated to show that there are sufficient layers of protection to mitigate the risk of contamination from the environment. Importantly, the environment housing the system is not a critical aspect of the process, because the product is never exposed to the outside environment,” says Pelletier.
This means that a cleanroom becomes an unnecessary waste of time and money.
“Cleanrooms will never be clean enough,” he says, because there are people in them, the single largest source of contamination. A single torn glove, or the door opened at the wrong time can put an entire batch of product at risk.
“Biologics manufacturers should be investing in process closure in lieu of investing in outdated, heavily customized, non-sustainable cleanrooms,” says Pelletier.
The use of properly conditioned isolators to provide layers of protection for functionally closed systems looks like an increasingly popular strategy for not only the future of the biologics industry, but also for our own cell & gene therapy industry.
About the Author
Alicia D Henn, PhD, MBA
Alicia Henn has been the Chief Scientific Officer of BioSpherix, Ltd for two years. Previously, she was a researcher at the Center for Biodefense Immune Modeling in Rochester, NY. Alicia obtained her PhD in molecular pharmacology and cancer therapeutics from Roswell Park Cancer Institute in Buffalo, NY and her MBA from the Simon School at University of Rochester in Rochester, NY.