کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
6488581 | 43039 | 2015 | 17 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Single-use in the biopharmaceutical industry: A review of current technology impact, challenges and limitations
ترجمه فارسی عنوان
تنها استفاده در صنعت بیوفارمتیک: بررسی تاثیر فناوری فعلی، چالش ها و محدودیت ها
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کلمات کلیدی
USPDSPDFFSMBICPBSLCIPLDPECRFPDASIPEMEANVRASTMTOCSUTFDABPSAWFImAbheating ventilation air conditioningsingle-use bioreactorperformance qualificationPVACOGs - COG هاTff - TFFwater for injection - آب برای تزریقMonoclonal antibody - آنتی بادی مونوکلونالEuropean Medicines agency - آژانس دارویی اروپاEuropean standard - استاندارد اروپاییUltraviolet - اشعه فرابنفشUltrafiltration - اولترافیلتراسیونdissolved oxygen - اکسیژن محلولUnited States pharmacopoeia - ایالات متحده pharmacopoeiaISO - ایزوCho - برایSimulated moving bed - بستر متحرک متحرکbiopharmaceuticals - بیوفرم داروهاFourier-transform infrared spectroscopy - تبدیل فوریه طیف سنجی مادون قرمزChinese Hamster Ovary - تخمدان هامستر چینیcleaning-in-place - تمیز کردن در محلHVAC - تهویه مطبوعAmerican society for testing and materials - جامعه آمریکایی برای آزمایش و موادSUB - زیرInternational Organisation for Standardisation - سازمان بین المللی استاندارد سازیFood and Drug Administration - سازمان غذا و داروbiosafety level - سطح بیوشیمیCMOS - سیماس یا نیمرسانای اکسید فلزی مکمل FTIR - طیف سنج مادون قرمزMass spectrometry - طیف سنجی جرمیEuropean Pharmacopoeia - فارماکوپه اروپاییDownstream processing - فرایند فرآیند پایینReview - مرورRegulation - مقرراتCosts - هزینه هاinductively coupled plasma - پلاسما جفتشده القاییLow-density polyethylene - پلی اتیلن کم چگالیPolyvinyl acetate - پلی وینیل استاتPVC - پلیوینیل کلراید یا پیویسیCode of Federal Regulations - کد قوانین فدرالhigh-performance liquid chromatography - کروماتوگرافی مایعی کاراHPLC - کروماتوگرافی مایعی کاراGas chromatography - کروماتوگرافی گازیTotal organic carbon - کل کربن آلیPolyvinyl chloride - کلرید پلی وینیلdisposables - یکبار مصرف
موضوعات مرتبط
مهندسی و علوم پایه
مهندسی شیمی
بیو مهندسی (مهندسی زیستی)
چکیده انگلیسی
As the biopharmaceutical industry matures, the trend towards increased flexibility and productivity, faster time to market and greater profitability are driving the replacement of traditional stainless steel equipment by single-use technology (SUT). The use of SUT in the biopharmaceutical industry can significantly impact the manufacturing process efficiency by reducing capital costs, improving plant flexibility, reducing start-up times and costs, and eliminating both non-value added process steps and the risk of cross-contamination. In addition it significantly reduces process liquid waste, labour costs and on-site quality and validation requirements. This paper reviews the current status of the technology and the impact of SUT in the biopharmaceutical industry, with the aim of identifying the challenges and limitations that still need to be addressed for further adoption of these technologies. Even tough SUT has a multitude of systems available, its components and assemblies have little standardisation as well as a lack of harmonised tests and procedures among suppliers, with an array of guidelines from a variety of sources and no critical limits have been established. In addition, the use of SUT has new validation requirements such as leachables and extractables, suppliers' qualification and SUT lot-to-lot variability. The lack of expertise in these areas and the new training requirements when using SUT also need to be addressed. To date the majority of the available literature regarding SUT is found in trade journals where typically suppliers are the main contributors. There is still a lack of engagement of the academic community, which contributes to very limited scientific proof from independent peer-reviewed research to support performance of SUT. This is particularly the case during operation and integrity testing of SUT, during for example on-site testing, transport and disposal. Another area where no work has been undertaken concerns conceptual approaches for facility clean-room requirement and appropriate layout design using SUT. Investment in novel technologies, research, standardisation and training is paramount for further development and implementation of SUTs across all sectors of the biopharmaceutical industry.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Food and Bioproducts Processing - Volume 93, January 2015, Pages 98-114
Journal: Food and Bioproducts Processing - Volume 93, January 2015, Pages 98-114
نویسندگان
Adriana G. Lopes,