Lack of standards and regulations is constraining the adoption of single-use bioprocessing technology. So says the 8th Annual Report and Survey of Biopharmaceutical Manufacturing from market researcher BioPlan Associates.
Writing in Pharma IQ magazine, managing partner Eric Langer notes that, while decrying the lack of both regulations and standards, survey respondents showed little interest in pushing the matter or even in determining who should take the lead.
Specifically, more than 40% of respondents identified the lack of "clear regulatory guidance on leachables and extractables" as constraining their use of disposables. Some 352 global biotherapeutic developers and contract manufacturing organizations participated in the survey.
Manufacturers themselves may be best positioned to take on the role of standards-setters, Langer notes in the article. Suppliers "better understand the challenges" of disposable product design and engineering, leachable/extractable characteristics and standards implementation than do end users, who are primarily in research and clinical settings.
- here's the story