In response to the increasing biologics manufacturing industry shift into single-use, closed system processing technologies, as well as increasing regulatory requirements to de-risk processes1,2, our Rockville, Maryland, U.S. facility is moving routine expansion of suspension cells into a closed process format.
The closed system is designed to avoid exposure of the product or material to the room environment by connection of closed Erlenmeyer® flasks and culture components using sterile tubing and fusion systems, which will reduce contamination risk through reduction of operator intervention in the manufacturing process. Use of closed manufacturing systems allows expansion of production capacity by enabling multiple cultures to be present in the same processing area. By incorporating segregation techniques and developing cross contamination controls we are able to achieve a ‘ballroom’ format3 without additional changes to the key culture systems, in terms of main product contact material during incubation.
Learn about our transition to closed processes for expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.