The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
暫譯: 生物製藥CMC法規遵循的挑戰

Geigert, John

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
  • 出版商: Springer
  • 出版日期: 2013-05-07
  • 售價: $9,720
  • 貴賓價: 9.5 折 $9,234
  • 語言: 英文
  • 頁數: 338
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 1461469155
  • ISBN-13: 9781461469155
  • 相關分類: 生物資訊 Bioinformatics、資訊安全

    • 海外代購書籍(需單獨結帳)

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商品描述

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

商品描述(中文翻譯)

本書強調了當前生物製藥環境中質量保證/質量控制（QA/QC）所面臨的挑戰，並展示了QA/QC在製造控制中的戰略重要性和所產生的價值。它將從早期臨床試驗到市場批准的過程中，闡明對QA/QC採取分級方法的必要性。自2004年首次出版以來，食品藥品監督管理局（FDA）、歐洲藥品管理局（EMA）和國際會議（ICH）已發布超過50項新的監管指導，這些指導影響生物製藥的CMC監管合規性；此外，生物相似藥的應用已在歐洲發展，並在美國進行開發。修訂版將擴展至不僅包括生物製藥（生技藥物），還包括其他生物製劑（疫苗、細胞療法、血漿衍生蛋白等）。

作者簡介

John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee. Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).

作者簡介(中文翻譯)

約翰·蓋格特是生物製藥品質解決方案公司的總裁，該公司專注於為生物製藥和生物產品行業提供 CMC（化學、製造和控制）法規策略諮詢。蓋格特博士在生物製藥行業擁有超過 35 年的 CMC 工業經驗和領導能力。蓋格特博士曾擔任 PDA（製藥技術協會）董事會成員，聯合主持 PDA 生技諮詢委員會，並擔任 USP（美國藥典）生物技術委員會的專家成員。蓋格特博士為法規事務專業協會（RAPS）撰寫了大量文章，包括《高層管理人員需要了解的生技產品 CMC 法規合規性》（2009 年 8 月至 11 月，四部分系列）和《解密 CMC 法規策略》（2011 年 9 月至 2012 年 3 月，四部分系列）。

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