کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2485895 | 1114370 | 2010 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
On Developing a Process for Conducting Extractable-Leachable Assessment of Components Used for Storage of Biopharmaceuticals
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Extractables and leachables are productârelated impurities that result from product contact with components such as gaskets, stoppers, storage bags, cartridges, and prefilled syringes that are used for processing, storage, and/or delivery of biopharmaceuticals. These impurities are a concern for patients due to potential effects on product quality and safety. It is possible that such an impurity could directly impact the patient or indirectly impact the patient by interacting with the protein therapeutics and forming protein adducts. Adducts and leachables may or may not be detected as productârelated impurities in routine stability indicating assays depending on the rigor of the analytical program. The need for the development of a thorough and holistic extractable and leachable program based on risk assessment, review of existing literature, and consolidation of industry best practices is discussed. Standardizing component use within an organization enables streamlining of the extractable-leachable program. Our strategy for an extractable-leachable program is divided into different stages, each stage detailing the activities and the department within the organization that is responsible for execution of these activities. The roles and responsibilities of the key stakeholders are identified. The integration of analytical activities with healthâbased riskâassessment information into the design of an extractable-leachable program is highlighted. © 2009 WileyâLiss, Inc. and the American Pharmacists Association J Pharm Sci 99: 2209-2218, 2010
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 5, May 2010, Pages 2209-2218
Journal: Journal of Pharmaceutical Sciences - Volume 99, Issue 5, May 2010, Pages 2209-2218
نویسندگان
Aditya A. Wakankar, Y.John Wang, Eleanor CanovaâDavis, Stacey Ma, Dieter Schmalzing, Josh Grieco, Terry Milby, Theresa Reynolds, Kellen Mazzarella, Ed Hoff, Stephen Gomez, Sherry MartinâMoe,