“Single-use systems have not been fully adopted by industry, but they are well on their way,” director of life sciences at technology and consumables firm Entegris Eric Isberg told Biopharma-Reporter.
“There has been plenty of growth over the past few years but we are still in the early stages of adoption, and this growth is likely to continue.”
Isberg has just begun a two-year term as a member of the Board of Directors of the Bio-Process Systems Alliance (BPSA), a trade association for the single-use bio-processing industry, but spoke to us regarding his own views and opinions based on 20 years of experience in the life sciences sector.
“Once people saw it as a choice of either single-use or stainless steel systems but now new installations are being designed for both. It is rare that a manufacturing train is installed without having the capabilities for both.”
The time-saving and reduced contamination risk benefits of single-use bioreactors are well documented, but a major criticism made by end-users – including Pfizer and Janssen – concerns their limited scale for commercial production, compared to the 15,000L, 20,000L and beyond capacity of stainless steel tanks.
“2,000L is really a ceiling for single-use bioreactor bags. And with such a size there is actually a lot of stainless steel involved in the structure – the bag itself while obviously very important within the system is a minor component, relatively,” Isberg told us.
“The pressures involved on single-use systems are very significant. There are five or six pounds per square inch (psi) of pressure at the bottom of a [2,000L] bag during operations, and single-use systems are normally designed for pressures up to two psi.”
That’s not to say 2,000L or more is unobtainable. Many biomanufacturers have installed, or are planning to install, such scale in their facilities – see Fujifilm, CMC Biologics, Catalent, and Rentschler, for example – and Pennsylvania-based vendor ABEC has even launched a 4,300L disposable bag with a working volume of 3,500L.
“It’s not a matter that manufacturers don’t desire such volumes, but the practicalities of such scale are a challenge and present an opportunity for the industry,” said Isberg. “Systems of 1,000L or larger require a significant learning curve for an end-user to manage.”
He suggested better plastics, better designs and better accessories such as tubing and cable ties will make implementing larger systems easier, as will greater cooperation between vendors and end-users.
BPSA and BPOG
As such, the BPSA – conceived as an industry group for disposable system vendors – is looking to increase and diversify its membership.
“Currently we have 55 members, five or six of which are end-users. However, this is changing as end-users become more active in single-use.”
While there have been conflicts between BPSA and the biopharma end-user industry association BioPhorum Operations Group (BPOG) in the past – specifically regarding the creation of an extractables protocol – the two groups have begun working closer together to tackle common issues, Isberg added, something in which he believes will continue going forward.
"The two groups are increasingly collaborating and they have a more positive relationship now."
Isberg replaces Catalent’s Bill Hartzel who stepped down from the BPSA Board of Director in November.
CLARIFICATION - The article has been updated to make it clear Isberg was speaking to us on his own views and opinions based on 20 years of experience in the life sciences sector, and his opinions do not necessarily representing the entire BPSA.