Data from BioPlan Associates' 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production show the industry is demanding better upstream and downstream processing. The survey, which had responses from 352 global biomanufacturers, analyzed production, budgetary, technological, and quality issues. The study showed that the industry is interested in new-product innovation in single-use bioreactors, cell-culture media, and various service areas (1).
Partly due to the slow-changing and strict regulatory environment, single-use suppliers are focusing on relatively traditional bag-liner-in-a-steel-bioreactor single-use systems. Much of industry's desire for improved bioreactors is related to the need for large-scale (e.g., >1000-L batch-fed), single-use/disposable bioreactors. Today, 1000 L is currently the largest cost-effective size for disposable batch-fed bioreactors. Future areas for single-use bioreactor innovations may include unitary (i.e., single-piece) all-plastic rather than plastic-lined and even stainless steel-lined plastic bioreactors.
Contract manufacturers have more interest in improved single-use bioreactor systems compared with product developers/manufacturers, according to the study. Interest in disposable bioreactors also differed among regions. Respondents from Europe (32.2%) showed the highest interest compared with 26.9% from the United States, and 31% from the rest of the world (1).
The study also surveyed 175 suppliers and examined 52 equipment and functional areas. The results showed most suppliers are involved in new-product development and that single-use bioreactors is the hottest area of new-product development; 40.5% of respondents are working on them in some way. Expression-system platforms and cell-culture optimization also were key areas of new-product development (1).
The study further evaluated 15 areas where biomanufacturers were actively implementing performance improvements in their facilities. The greatest percentage of facilities had "significant" or "some" improvement from better process development (identified by 66.8% of respondents) and optimized cell-culture processes (identified by 61.9% of respondents) (1).