کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5856167 | 1131968 | 2015 | 45 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Proof of concept for a banding scheme to support risk assessments related to multi-product biologics manufacturing
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کلمات کلیدی
ADETNFFDAacceptable daily exposuregranulocyte-macrophage colony stimulating factorMTDGM-CSFPDEmAbsLD50APICross-contamination - آلودگی صلیبRisk assessment - ارزیابی ریسکinterferon - اینترفرونIFN - اینترفرون هاinterleukin - اینترلوکینBiologics - بیولوژیکCleaning validation - تأیید اعتبارMaximum tolerated dose - حداکثر دوز قابل تحملIntravenous - داخل وریدیsubcutaneous - زیر جلدیManufacturing - ساختFood and Drug Administration - سازمان غذا و داروGranulocyte colony stimulating factor - عامل تحریک کننده کلنی گرانولسیتیکIntramuscular - عضلانیG-CSF - فاکتور محرک کُلونی گرانولوسیتtumor necrosis factor - فاکتور نکروز تومورPermitted daily exposure - قرار گرفتن در معرض روزانه مجاز استActive Pharmaceutical Ingredient - مواد اولیه دارویی فعالmedian lethal dose - میانگین دوز مرگبارImpurities - ناخالصی هاinternational unit - واحد بین المللیMonoclonal antibodies - پادتنهای تَکتیره
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
A banding scheme theory has been proposed to assess the potency/toxicity of biologics and assist with decisions regarding the introduction of new biologic products into existing manufacturing facilities. The current work was conducted to provide a practical example of how this scheme could be applied. Information was identified for representatives from the following four proposed bands: Band A (lethal toxins); Band B (toxins and apoptosis signals); Band C (cytokines and growth factors); and Band D (antibodies, antibody fragments, scaffold molecules, and insulins). The potency/toxicity of the representative substances was confirmed as follows: Band A, low nanogram quantities exert lethal effects; Band B, repeated administration of microgram quantities is tolerated in humans; Band C, endogenous substances and recombinant versions administered to patients in low (interferons), intermediate (growth factors), and high (interleukins) microgram doses, often on a chronic basis; and Band D, endogenous substances present or produced in the body in milligram quantities per day (insulin, collagen) or protein therapeutics administered in milligram quantities per dose (mAbs). This work confirms that substances in Bands A, B, C, and D represent very high, high, medium, and low concern with regard to risk of cross-contamination in manufacturing facilities, thus supporting the proposed banding scheme.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 73, Issue 2, November 2015, Pages 595-606
Journal: Regulatory Toxicology and Pharmacology - Volume 73, Issue 2, November 2015, Pages 595-606
نویسندگان
Jeffrey W. Card, Hana Fikree, Lois A. Haighton, James Blackwell, Brian Felice, Teresa L. Wright,