Large-scale biopharmaceutical manufacturing equipment for upstream product manufacture has changed relatively little over
the past decades. Innovation in bioprocessing equipment, particularly, bioreactors, has been slow despite some gains, such
as cost improvements, greater flexibility, higher product yields resulting from improved genetic and cell engineering, and
widespread adoption of small-scale, single-use bioprocessing equipment.
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).
A key finding of the study was interest in upstream equipment innovation. Bioreactors are one of a company's largest bioprocessing
expenses. To illustrate interest in alternative bioreactors, more than two-thirds (68.1%) of survey respondents reported current
in-house use of single-use bioreactors, and this percentage is growing, especially in research and development and clinical-scale
production. Improvements in bioreactors, particularly for single-use, along with purification equipment, were ranked as the
areas where bioprocessing innovations were reported as most needed, with 29.2% of respondents citing bioreactors as a key
area (see Figure 1).
Figure 1: Areas identified by survey respondents in most need of new upstream product and services development. (FIGURE 1
IS COURTESY OF AUTHOR)
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).