Single Use Device Adoption Impacted by Slow Standards Setting
BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, 2011, identifies the growing need for standards to support rapidly emerging and evolving single use, disposable technologies. Standards, or the lack thereof, are inhibiting expanded use of SUS devices. For example, this year’s survey of “Factors That May Restrict Use of Disposables,” biotherapeutic developers and CMOs agreed that “No clear Regulatory Guidance on Leachables and Extractables” is reducing their usage (44.3% and 40%, respectively).
Our study indicated the industry’s expectations of which organisations should be responsible for various standards-setting. However, the diversity of opinion suggests that establishing a consensus may require time.
Fig 1 Standards-Related Factors that may Restrict Use of Disposables in Biomanufacturing.
Leachables and Extractables (L&E) Critical to Standards
In our annual survey of 352 global biotherapeutic developers and contract manufacturing organisations we asked respondents what organisations should be setting standards. We examined three categories: Leachables and Extractables, Design and Engineering, Component Manufacturing Control (Quality). Because multiple organisations can be responsible for standards in any industry, participants were able to indicate more than one group.
Leachables and extractables category, (which also leads the 2011 list of Factors Restricting Use of Disposables) are a key concern. Worries over “leachables and extractables” have increased for both groups over the past 4 years. Fortunately, standards setting may serve a role in improving SUS implementation. (see www.bioplanassociates.comfor information on organisation(s) establishing standards in biomanufacturing) 
For Leachables and Extractables, the ICH (International Conference on Harmonisation) and the USP (United States Pharmacopeia) were indicated among end-users as the organisations that should be responsible for “L&E” standards.
Design and Engineering Standards
For setting design and engineering standards, the ISPE International Society of Pharmaceutical Engineers edged out others, among both end-users and vendors/suppliers (29.9% and 37.6%, respectively). The ASME (American Society of Mechanical Engineers -BioProcessing Equipment Standard, BPE) followed, with 19.7% of end-users, and 35.5% of vendors/suppliers.
Component Manufacturing Control (Quality)
For Component Manufacturing Control (Quality), the regulatory body ICH was indicated first among end-users, followed by PDA (Parenteral Drug Association) (24.8% and 8% of end-users, respectively). Among vendors and suppliers, 22% indicated ICH should be responsible for “Component Manufacturing Control (Quality)” standards.
Single use devices are becoming standard equipment at many biomanufacturing facilities, certainly at research and clinical manufacturing scales. To achieve greater acceptance, standards are needed. Because end-users in most industries are in many cases not aware of (or particularly care about) who sets industry organisations, some in this industry are calling on the manufacturers (who have a vested interested in stability concerning standards. These makers and suppliers of single use components better understand the challenges associated with design, engineering, leachable/extractables and implementation of appropriate quality control standards. According to Katherine Ulman, Associate Scientist, Healthcare Industries, Dow Corning Corporation, it may be these vendors who should take on a more active role to become, “more of a leader in developing and setting their industry standards.”
 8th Annual Report and Survey of Biopharmaceutical Manufacturing, April, 2011, BioPlan Associates, Inc. www.bioplanassociates.com
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