During the past six years, single use systems and devices have emerged as a key change agent in the biomanufacturing landscape. Acceptance in R&D and scale-up has been driven by their effectiveness in reducing risks of contamination, faster changeovers, advantages over fixed stainless steel systems in cleaning and validation, and significantly reduced time, and costs to get a new facility up and running. Now, single use products have pushed beyond an early-stage technology, and are poised to emerge into the much larger, GMP commercial-scale operations. The emergence of single use devices onto the commercial stage is likely to create radical changes in the biomanufacturing landscape. Key to this is first to resolve safety issues associated with leachables and extractables. Comparability with existing processes (stainless steel) will result in more rapid adoption rates. The needs in single use technologies that will assure GMP operations—and biomanufacturers’ applications and integration of them--have driven end-users to demand vendors put R&D efforts into these devices. In fact, according to BioPlan Associates, Inc.’s 2011 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production[1], single use devices top the list of key areas where biomanufacturers want to see product development.
Table 1: Top Areas Where Vendors & Suppliers Should Focus New Product Development Efforts (selected study results)
Source: 8th Annual Report and Survey of Biopharmaceutical Manufacturing; Preliminary data,
pub April 2011; BioPlan Associates, Inc. http://www.bioplanassociates.com/
These responses for where new products are being demanded reflect both the growing acceptance of disposable/single-use devices, and the growing need for better systems. Nearly 39% of the industry wants vendor innovation in basic singleuse devices, suggesting significant opportunities for companies with inventive R&D initiatives and product development capabilities.
The need for more effective, standardised single use equipment is generally felt by both vendors and end-users. Improvement is most strongly called for in "extractables and leachables” which leads the list in “Reasons for Restricting Use of Single-Use Devices”, cited by 74% of 2011 respondents (up from 68% in 2010).
These data suggest an opportunity for vendors with R&D that delivers better materials. Both significant levels of innovation and incremental changes are needed to spark improvements that facilitate use of single use devices. Survey respondents indicated the following as specific areas in need of improvement:
• Simplifying change-over and cleaning operations
• Reducing overall capital investments
• Reducing risks of product cross-contamination
• Speeding up time to get facility up and running
• Improving campaign turnaround times
• Standardising devices to avoid costs of system modifications
• More ‘modular’ approaches
• Reducing space requirements
• Improving assurance of sterility
• Decreasing documentation requirements; simplify QA/QC
• Improving sterile-sampling
• Simplifying overall operations to reduce learning curve for new operators
• Improving control of bioreactors
• Reducing the need for operations staff
• Improving strength and reliability—to reduce bag breakage
Such solutions will require innovative leadership, process documentation, and training that demonstrate how devices can be effectively integrated into operations. In fact, industry experts believe process simplification will be the real driver for single use success. Single use vendors are likely to see profitable opportunities when they go beyond the current new product strategy of simply replacing stainless steel with plastics. This overall process can be summarized as strategic productionmanagement and this is a term more and more in use.
Hand-in-hand with innovation will be the need for standardisation of the currentlyproliferated, unique designs and devices. “While there is a huge amount of specific activity, we believe the future of single-use technologies will include higher levels of integrity and quality, supply chain security, faster delivery to customers and global material and specification standards for faster implementation,” says Doug Neugold, CEO, ATMI.
To get to the next level of growth and efficiency will likely require a more ‘plug-andplay’ device approach guiding product design and innovation. This kind of standardisation will also permit greater efficiency and lower costs. Thus, to get beyond the current steady rate of adoption, innovation may focus on making production easier for people with fewer skills, on a global perspective.
[1] 8th Annual Report and Survey of Biopharmaceutical Manufacturing, Preliminary Data, Publication; Date April, 2011, BioPlan Associates, Inc. www.bioplanassociates.com
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