GE Healthcare’s David Radspinner told in-PharmaTechnologist: “As the new wave of biologics has been developed with higher titers coming through R&D pipelines, many biopharma manufacturers are considering single-use technologies as their primary manufacturing option."
“The production requirements are changing: biomanufacturing requires more flexibility and smaller scale, as more precise therapies are being developed for smaller patient populations.”
Thermo Fisher Scientific’s Surendra Balekai said the industry is adopting single-use technologies as the scale of operations change.
“With advancements in cell line and cell culture media development, expression rates have increased over 10 times compared to a decade ago.”
“The molecules (both novel and biosimilars) under development and in clinical trials will need commercial scale facilities that can be easily supported with available single use technologies,” he added.
The move to single-use
The National Institute for Bioprocessing Research and Training’s (NIBRT) John Milne told us Ireland’s biopharma manufacturing industry is mainly concerned with the large-scale manufacture of recombinant proteins, and in particular monoclonal antibodies therapies.
Milne said the scale of manufacture in Ireland has affected the choice of bioreactors to date.
“As a consequence of disease indications, generally large patient bases and the high dose requirements for antibody therapies the production bioreactor in these facilities tend to be 10,000 L or above,” he said.
While Milne said reactors of this volume are not available in plastic, single-use configuration, for smaller scale ‘seed’ bioreactors, companies are open to using single-use versions from 1,000L to 2,000L volume.
Balekai has also observed an increase in the implementation of single-use technology, which he said can be attributed, in part, to a boost in industry confidence.
“It has been over a decade since first introduction of stirred tank bioreactor technologies to the market, and a lot has happened in building confidence in terms of quality, assurance of supply and regulatory aspects,” he said.
He said most facilities constructed in the last year have implemented single use platforms.
“Biopharma manufacturers, where possible, have been considering a hybrid approach. In the last two years, we have seen some conversion to single-use,” he told us.
Milne said that although the industry has been hesitant to adopt single-use, the benefits of the technology are wide-ranging.
“If you combine this activity with operations such as buffer/media preparation, filtration configurations, harvesting/clarification and storage of buffers, most companies are positively disposed to the implementation of single-use systems.”
“We know that companies who may have been perhaps a little reticent to incorporate single-use technologies to date are looking closely at the wide ranging benefits that such systems can bring to a manufacturing plant,” he said.
A history of large-scale
While Balekai said single-use technologies are conducive to current biomanufacturing practices, he told us this was not the case at the beginning of the decade.
“Most of the top biopharmaceutical companies invested in Ireland around 2011- 2012. In those years, single-use technologies were restricted to a couple of bioreactors and limited mixing, storage applications,” he said.
“Some of the blockbuster molecules made in Ireland were developed on low expression cell culture platform and needed large scale bioreactors (>2000L).”
“There was less scope for the adoption of single use technologies in the process design and stainless steel infrastructure was a default option,” he said.
Earlier this month NIBRT and GE Healthcare opened the ‘NIBRT-GE Single-Use Centre of Excellence, a single-use focused training facility in Dublin.