Bioreactors are constantly evolving, with improvements being introduced rapidly. To assess how the industry will be adopting and using some of these new technologies, at both clinical and commercial manufacturing scales, we asked more than 300 biomanufacturers their approaches to adoption of these new technologies.
The results, contained in BioPlan Associates’ 9th Annual Report and Survey of Biopharmaceutical Manufacturers, suggest that biologics currently in the pipeline will likely be made in single-use, disposable bioreactors. Respondents indicated a clear preference for these devices, and it is likely they will be overtaking fixed, stainless facilities in the near term.
One of the questions in this year’s study asked respondents to list the bioreactor types they would specify for a new facility for clinical- or commercial-scale biologics manufacturing planned for operation two years from now.
For clinical scale, two-thirds (66.9%) of our respondents expect to implement batch-fed single use bioreactors. This compares to 31.4% who would choose batch-fed stainless steel bioreactors. With single-use bioreactors already dominating many areas of precommercial, including clinical supplies and the manufacturing market, it is no surprise that these would be predominantly specified for future clinical manufacture.
It is notable, however, that only slightly more than half (53.5%) would specify batch-fed stainless steel bioreactors for commercial manufacture, as batch-fed stainless steel currently dominates the commercial stage. This result may indicate an increased willingness on the part of the industry to adopt single-use systems or otherwise abandon batch-fed stainless steel systems for commercial manufacture.
In fact, a significant 44.2% said they would specify single-use batch-fed bioreactors for future commercial manufacture. This result may be impacted by the industry’s general perspective, also identified in our global study, that the vendors and new product innovators of single-use devices will resolve some of the nagging problems associated with adoption. These include leachables and extractables concerns, standardization issues, and breakage problems.