The shift to disposable systems among biomanufacturers has been well reported, and according to experts at a recent bioprocessing show traditional stainless steel systems have become the niche single-use was five-years ago.
Stainless steel facilities still have their place, but according to Amit Dua, global solutions marketing leader at GE Healthcare, the flexibility and the economic benefits disposable systems offer (see here, here and here) continue to drive adoption of single-use.
Furthermore, he told Biopharma-Reporter, with fewer potential blockbusters and a shift towards lower volume, orphan drugs and personalised medicines, there are fewer reasons to invest in large-scale stainless steel facilities.
“We’re seeing three types of manufacturing models: 100% conventional stainless steel, hybrid and 100% single-use,” he said, “and each are deployed based on a manufacturer’s needs.”
Fully stainless steel sites cater for capacities over 50,000L, and generally make just one or two approved ‘blockbuster’ biologics.
Examples would be Genentech’s monoclonal antibody production facility in Vacaville, California, and Samsung Biologics biosimilar site in Korea, both of which produce large capacities to feed demand for approved drugs.
“For Phase II/III biologic developers, they are very much in the middle. There is no sense of setting up a $100m stainless steel pilot plant for a molecule that has a 50% chance of being approved, so therefore a hybrid facility will be the preferred option,” said Dua.
And for the large number of early-stage candidates in development, which have even less chance of reaching commercialisation, the goal is to move into Phase II as quickly as possible, so companies opt for fully single-use plants to save time and cost.
“For the most part companies are looking for flexibility,” he added.
Dua’s views echo those of other experts. Last month, BioPlan Associates managing director Eric Langer told this publication that while single-use is the future, stainless steel bioreactors will always play a role in drug production, with the adoption of hybrid systems driving innovation in the stainless steel technology sector.