Developments in single-use technology signals the end for clean-in-place biomanufacturing methods, according to ThermoFisher’s Bill Whitford.
Speaking to Outsourcing-Pharma, the senior manager of the bioprocessing market told us that the new systems have the potential to drive development because they free-up the time and money set aside for traditional production methods, allowing drugsmakers to spend them on more important matters.
“Primary sponsors, CMOs, and biotechnology pundits agree that we have entered the age of single-use technology,” he said.
“Process efficiency is supplied by such single-use features as increased operational flexibility, reduced process turnaround time, ease and safety in product changeover, and economy of site-to-site transfer or replication.”
He said the fact hardware for single use mixers and bioreactors (SUBs) can be constructed and installed in a matter of weeks, reducing equipment design and build times, means more time can be spent on product development.
“Because they do not require clean-in-place and steam in place, single use technologies accelerate facility design and construction schedules.”
And advancements in single-use technology is also good news for continuous production, said Whitford
“A big advantage here is that development runs can be made more frequently because of the reduced turnaround time with single use reactors and mixers-which is often a matter of hours.”
He added that the flexibility of the equipment is a plus, saying: “Many single-use skids have been designed to be easily re-located to new locations within plant, and this not only provides new development opportunities, but can shortening product development time.”
The perks for CMOs
When asked if he envisions single-use systems available within all CMOs (contract manufacturing organisations) in the future, Whitford replied: “With only few exceptions, most emphatically yes.”
He said that the flexibility of the technology, such as the ability to change between manufacturing platforms, is a huge force behind this.
“It's very comforting to a CMO to know that they are ready for an opportunity in suspension or microcarrier based culture and in products requiring any of batch, fed-batch or perfusion modes,” he said.
“First of all, the system and unit operational modularity and hybrid system capability are very powerful here. But CMOs also value flexibility in process flow and configuration as well as in product type or classification of a particular campaign.”
The answer industry has been searching for?
Whitford also said he thinks disposable tech could be the key to developments in the orphan drug and personalised medicine arenas.
“Of particular value here is the demonstrated scalability, ease and speed in scaling-out for increased manufacturing capacity, and economy of maintaining a serge-capacity for future demand,” he said.