Modular single-use facilities rebalance Biopharma’s capacity scales
With over 600,000L of stainless steel cell culture capacity across four mammalian biomanufacturing sites, Lonza is the largest biologics contract manufacturing organisation (CMO) and – together with Boehringer-Ingelheim – is thought to be responsible for over half of all biologics made commercially by third-parties by both volume and revenue.
But last week, the CMO announced it was building the first of up to five modular biomanufacturing facilities set to house single-use bioproduction systems at its site in Visp, Switzerland to offer its clients flexible manufacturing capacity. The news came weeks after Lonza revealed details of an 8,000L single-use expansion at its Singapore site.
Lonza is not the first to embrace modular facilities and single-use. Modular plants were described as the “harbinger of change” in drug productionby an engineering expert back in 2012, and more recently the concept has been realised through new facilities from drugmakers such as Amgen and JHL Biotech.
Meanwhile other CMOs, including Catalent, Patheon and Fujifilm, have forged their way into biopharma space by investing in single-use technologies and capacity.
What this demonstrates is single-use technology has come of age.
No longer is it being touted as a straight-up replacement to those giant stainless steel tanks in those giant costly factories. It is now a complementary and compatible option, supported by cost-effective and quick-to-build facilities, giving biopharma greater efficiency and flexibility in managing its capacity utilisation.
“In terms of capacity the industry looks like it is achieving a degree of maturity,” Eric Langer, president of life sciences marketing research firm BioPlan Associates told Biopharma-Reporter.
According to the 14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, published by his company earlier this year, there is over 17 million litres of biomanufacturing capacity available worldwide with current utilisation reported to be on average “a very healthy” 73.6% for mammalian cell culture production.
“There has been a lot debate as to whether there is going to be an upcoming capacity crunch but we see a degree of optimism that the ability to manage overall capacity is being demonstrated.”
Among the 227 survey respondents, only 10.5% reported “severe constraints” at commercial manufacturing scales, with lower rates reported for earlier-phase development.
This is a far cry from capacity issues in the early 2000s where demand outstripped available capacity (utilisation rate stood at 107% in 2002) and the over-supply situation after the global economic crisis in 2008 which led to utilisation rates plummeting to below 50%.
But while industry is better than it historically has been at preplanning, Langer said the situation has been alleviated through single-use technologies which creates flexible capacity options allowing drugmakers to rapidly bring on capacity through modular facilities, whether in-house or via a CMO.
And vendors too are identifying single-use’s concordant place in the biomanufacturing landscape, moving away from pushing disposables as a conflicting concept to traditional stainless systems and instead developing standalone alternatives to suit specific needs.
GE Healthcare recently broke ground on its own ‘off-the-shelf’ biomanufacturing campus in Ireland utilising its FlexFactory single-use and KUBio modular platforms – the same technologies which formed JHL’s modular facility in China.
And Thermo Fisher – which said in 2012 single-use could signal the end for clean-in-place biomanufacturing methods – has begun using its single-use technology in combination with its SmartFactory automated technology to help design and develop production plants for end-users.