The spectacular growth in biotechnology over the past year hasn’t been only about coronavirus and the quest for global immunity. More than 100 COVID-19 vaccines are in development—one for every two countries (and approximately 100 more than we will ever need). R&D, clinical trials, and products all need manufacturing space.
Yet, according to Maik Jornitz, CEO of G-CON Manufacturing, most of the surge in facility expansions, while indeed biotech- (vs. small molecule-) inspired, involves not vaccines or large-market monoclonals, but cell/gene therapies and small-volume mAbs.
“Our own market research on growth within these segments, conducted in collaboration with L.E.K. Consulting, indicates that demand for capacity is outstripping supply,” says Jornitz. Unlike yesteryear’s “capacity crunch” in monoclonal antibody production, this one will not be solved by a tenfold improvement in titers or yield.
“New facility and cleanroom infrastructure are urgently needed to fulfill these needs, as the old and slow no longer work. Cleanroom infrastructure suppliers understand this, and recent standardization initiatives by G-CON, CleanSpace, and AES, and template designs by IPS and CRB, shows an industry moving away from reinventing the wheel to the built and proven. We have seen these initiatives shorten design timelines and reduce costs while enabling reliable delivery timelines and staying under budget,” Jornitz adds.
Expansion plans in place before pandemic
These expansion plans were in place before COVID-19, reflect the trending mix of emerging products in biotech, and are accelerating as projects at contract manufacturing facilities become even more backlogged.
“As development pipelines expand, we expect many more sites going up for clinical materials, followed by commercial facilities,” Jornitz says.
Jornitz believes that a capacity crunch would be in the offing even without COVID-19, “but COVID-19 and the reshoring efforts will put even further pressure on the capacity build-up.”
OK, biotech is booming, but we tend to associate capacity shortages with large-scale products like blockbuster monoclonal antibodies, not with emerging therapies. Many of these treatments fall under the “personalized” category.
That sentiment is true for cell therapy, but because patient samples require 10–14 days of processing in cleanrooms, the number of patients you can treat for a given cleanroom space is limited, explains Jornitz.
“Therefore, cleanrooms must be scaled-out to accommodate the growing patient base, and this must occur without interrupting the existing processing spaces,” he tells GEN. “That means the new and existing facilities require separate HVAC systems, for example. We developed a standard prefabricated cleanroom, or POD, portfolio for these projects. We can deliver a POD, with its own HVAC system, in under three months.”