Wanted: Better Upstream Bioprocessing Technologies - Pharmaceutical Technology

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Wanted: Better Upstream Bioprocessing Technologies
A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 7, Issue 7

Eric Langer
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).

Upstream innovation

Figure 1: Areas identified by survey respondents in most need of new upstream product and services development. (FIGURE 1 IS COURTESY OF AUTHOR)
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).

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).


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