Single-Use Bioreactor, also known as disposable bioreactors, offer several advantages over traditional stainless steel bioreactors. One major benefit is reduced risk of cross-contamination. In single-use systems, each run uses a new sterile bag or vessel rather than reusing and cleaning equipment between batches. This eliminates cleaning validation requirements and the risk of residual contaminants from previous manufacturing cycles.
Another key advantage is greater flexibility in production scheduling. Single-Use fermentors can be set up more quickly than stainless steel equivalents, often in a matter of hours rather than days. This allows for quicker turnaround between development and manufacturing runs. Plant capacity can also be more easily scaled up or down by adding or removing single-use reactor runs as needed. No complex and costly construction is required to modify cleanroom facilities and piping.
From an economic standpoint, Single-Use Bioreactor with stainless steel bioreactors like cleaning and validation can be avoided. Capital expenditures on large, fixed production equipment are also not needed. The single-use format reduces facility size requirements and lowers cleaning, maintenance and utility costs. Many manufacturers see overall production costs reduced by 20-30% compared to conventional biomanufacturing approaches.
Reduced technical complexity is another benefit. Single-use systems are self-contained and pre-sterilized with no on-site autoclaving or clean-in-place systems. Operation and monitoring is also simpler as no complex mechanical parts require calibration or cleaning. This simplifies technology transfer between manufacturing sites and lowers technical demands on staff.
Design Evolution of Single-Use fermentors
Early Single-Use fermentors were basic rigid tank designs. These offered improvements in flexibility and ease of use but still had some drawbacks. For example, the fixed geometry could limit mixing and oxygen transfer capabilities. More advanced second-generation systems addressed some of these issues.
Today's third-generation Single-Use fermentors feature flexible bags rather than rigid tanks. The bags conform to the shape of impeller and spindle assemblies inside, creating optimal flow characteristics for suspension cultures. Impeller positioning can also be adjusted for varying culture volumes.
Advanced mixing and aeration are achieved through top-drive or bottom-drive impeller configurations. Dissolved oxygen and carbon dioxide levels are carefully controlled. Sterilization filters ensure gases remain sterile without upstream processing.
Sophisticated sensor systems allow for online monitoring of hundreds of process parameters like pH, temperature, dissolved oxygen, and cell density. This data is integrated with bioprocess control software for automated data collection and process control.
Advanced Single-Use fermentor systems can now match or exceed the performance of small-to-mid scale stainless steel options. Mixing homogeneity, mass transfer properties, and process intensification capabilities continue to improve alongside digitalization and process analytics tools.
Upstream Process Optimization
Process optimization upstream during cell culture has been essential for maximizing Single-Use fermentor productivity. Engineering of high-performing cell lines that grow to high densities while producing target proteins is critical. Developing robust media formulations tailored to specific cell types has also helped to maximize viable cell concentrations and product titers.
Advances in upstream cell culture techniques like perfusion fed-batch processes allow for significantly higher cell densities than conventional batch processes. Perfusion maintains nutrient supply and removes toxic byproducts, supporting cell growth over longer durations at industrial scales. When combined with intensified single-use technology, this can boost volumetric productivities 5-10X higher than traditional processes.
Downstream Processing Challenges
While Single-Use fermentors have streamlined upstream cell culture, transferring the harvested material to downstream purification remains challenging. Current purification processes often still employ conventional large-scale stainless steel equipment for steps like centrifugation, chromatography, and filtration.
Integrating these downstream operations into single-use configurations present difficulties like material compatibility, integrated control systems, and product holdup across multiple single-use units. Extracting maximum value from single-use upstream investments will require further optimization of end-to-end single-use processing trains or modular standalone systems for purification steps.
Single-Use fermentor technologies have seen increased adoption driven by their clear advantages for clinical and commercial production. A 2019 industry report projected the Single-Use fermentor market to grow at over 13% annually to surpass $3.5 billion by 2025. With continued innovation in digital control systems, sensors, single-use equipment design, and process translation, these systems will likely become standard for mammalian cell culture manufacturing. Their flexible, lower cost operations will be critical to meeting growing global drug demands now and into the future.
Select the language you're most comfortable with.
Get More Insights On Single-Use Bioreactor
About Author:
Alice Mutum is a seasoned senior content editor at Coherent Market Insights, leveraging extensive expertise gained from her previous role as a content writer. With seven years in content development, Alice masterfully employs SEO best practices and cutting-edge digital marketing strategies to craft high-ranking, impactful content. As an editor, she meticulously ensures flawless grammar and punctuation, precise data accuracy, and perfect alignment with audience needs in every research report. Alice's dedication to excellence and her strategic approach to content make her an invaluable asset in the world of market insights.
(LinkedIn: www.linkedin.com/in/alice-mutum-3b247b137 )
copyright src="chrome-extension://fpjppnhnpnknbenelmbnidjbolhandnf/content_script_web_accessible/ecp_regular.js" type="text/javascript">