Avid Bioservices: 'The single-use facility is not all sunshine'
The contract development and management organisation’s (CDMO) director of manufacturing Sun Ra Bullins said the single-use facility is inherently flexible, offers time and cost benefits, and provides operational advantages in the manufacturing process, but also poses challenges: “The single-use facility is not all sunshine.”
One of the bigger challenges is managing fluid distribution, said Bullins at Interphex in New York last month, as limited sizing for disposable technology – including tubing – can result in limited flow.
“When moving from expansion to production to the downstream process, fluid requirements increase heavily, and with some of these high titer molecules coming out…you can reach a point in the process where you can be dealing with 10,000L of fluid,” he told delegates.
Bullins proposed using multiple, smaller volume tanks, which he said “can have some degree of effectiveness," but also poses potential floor space issues.
“When dealing with disposables, the warehouse space explodes. No matter how much warehouse space you think you need, you need more,” he explained.
Insufficient supply chain availability for disposable technologies also can cause manufacturing delays, he added, begging the question: “How much equipment do we need on hand in order to tackle some of these downsides of single-use?”