《生物製藥工藝案例研究》是生物製藥行業中小夥伴比較熟悉的一份資料，由於沒有中文版，給很多小夥伴增加了閱讀的壁壘。索性我就邊看邊翻譯，為公眾號的訂閱者提供一個探討的平臺，如果有翻譯不準確的地方，還請幫忙指正。
1 Introduction 介紹
1.1 Background and Acknowledgements 背景知識
In August of 2008, company representatives from Abbott, Amgen, Eli Lilly & Company, Genentech, GlaxoSmithKline, MedImmune, and Pfizer were brought together to help advance the principles contained in ICH Q8(R2), Q9 and Q10, focusing on the principles of Quality by Design. The application of QbD to biotechnology products represents an important opportunity as the manufacturing and development of such products involves unique challenges with regard to both drug substance and drug product manufacturing due to the complexity of both the products and the biological manufacturing processes.
2008年8月，來自雅培（Abbott）、安進（Amgen）、禮來（EliLilly）、美國基因泰克（Genentech）、葛蘭素史克（GSK，GlaxoSmithKline）、上海斯信生物科技（MedImmune）和輝瑞（Pfizer）公司的代表被聯合起來推進一些原則，這些原則包括ICHQ8(R2)、Q9和Q10，這些原則均是側重於質量設計的原則。QbD在生物技術產品中的應用代表了一個重要的機遇，在生物技術這類產品的製造和開發這兩方面都面臨著獨特的挑戰，原因在於原料藥（原液）和產品本身的複雜性和生物製造工藝的複雜性。
Through a series of inter-company and regulatory interactions, the group set out to create a case study that would stimulate discussion around how the core principles contained in these guidelines would be applied to product realisation programs, with a multitude of real world scenarios, as opposed to a singular approach. To that end, the CMC-Biotech Working Group set out to accomplish the following:
通過一系列公司間和監管部門的互動，該團隊著手創建一個案例研究，旨在引起一些討論：在這些指導方針中的核心原則是如何在大量的真實的場景中，應用於產品的實現的，而不是單一的方法。為此，CMC-生物技術工作組開始著手完成以下工作：
Create a comprehensive biotechnology case study that would support teaching and learning for both Industry and Regulators.
創建一個全面的生物技術案例研究，支持行業和監管機構教學。
Exemplify the more advanced principles and opportunities described in Q8(R2), Q9 and Q10 for both the active ingredient and the drug product.
舉例說明Q8(R2)、Q9和Q10中描述的對活性成分和藥物產品的更先進的原則和機會，。
Demonstrate the concept of "prior knowledge" and how it could be applied to demonstrate process understanding.
論證「先驗知識」的概念，以及它如何應用於演示工藝的理解。
Provoke and challenge current thinking in order to stimulate discussion and advance new concepts.
激發和挑戰當前的思維，以達到激發討論和提出新概念的目的。
To examine the potential opportunities to enhance science and risk based regulatory approaches associated with these advanced concepts that would encourage greater implementation of the recent ICH guidelines across the industry.
研究以加強科學和風險為基礎的法規方法的潛在機會，且伴隨著這些先進概念，將鼓勵在整個行業內更好地執行最近的ICH指南。
The Facilitators would like to thank the efforts of each of these companies and their representatives for demonstrating their eagerness to create a document for public consumption and ultimately be used as the backbone for further discussion between industry and agencies across 2009-2010 and beyond.
協調人要感謝這些公司及其代表所做的努力，他們表現出了創建供公眾使用的文檔的熱情，並最終成為2009-2010年及以後行業和機構之間進一步討論的支柱。
Many individuals and teams are owed sincere thanks for their contributions to the Biotech Working Group in creating this case study:
衷心感謝許多個人和團隊為生物技術工作組創建本案例研究所做的貢獻:
Amgen Team: Joseph Phillips (Lead), Lisa Ericson, Chulani Karunatilake, Bob Kuhn, and Anurag Rathore
Abbott Team: Ed Lundell (Lead), Hans-Juergen Krause, Christine Rinn, Michael Siedler, Sonja Simon, Carsten Weber, Brian Withers
Eli Lilly Team: Victor Vinci (Lead), Michael DeFelippis, John R. Dobbins, Matthew Hilton, Bruce Meiklejohn, and Guillermo Miroquesada
Genentech Team: Lynne Krummen (Co-Lead), Ron Taticek (Co-Lead), Sherry Martin-Moe, and Brian Kelley
GSK Team: Ilse Blumentals (Lead), John Erickson, Alan Gardner, Dave Paolella, Premthesh S. Patel, Joseph Rinella, Mary Stawicki, Greg Stockdale
MedImmune Team: Mark Schenerman (Lead), Gail Wasserman , Cindy Oliver, Kripa Ram, Laurie Kelliher, David Robbins, Jen Anderson, Sanjeev Ahuja, Nancy Craighead, Andy Niedzielski, and Orit Scharf.
Pfizer Team: Leslie Bloom (Lead), Amit Banerjee, Carol Kirchhoff, Wendy Lambert, and Satish Singh
The Team would also like to thank each of the Sub-Team Leads for their guidance and support:
生物技術工作組也要感謝每一個子團隊的指導和支持，他們是：
1) Introduction 介紹– Mark Schenerman
2) CQA 關鍵質量屬性– Mark Schenerman and Ron Taticek
3) Control Strategy控制策略 – Mike DeFelippis
4) Upstream 上遊– Ilse Blumentals
5) Downstream 下遊– Ed Lundell and John Erickson
6) Regulatory 法規– Leslie Bloom and Lynne Krummen
7) Drug Product 成品– Joseph Phillips
We would also like to thank Anjali Kataria for her help initiating the Case Study. The Group would also like to thank the MedImmune Scientific Writing Team of Nancy Craighead, Andy Niedzielski, and Orit Scharf for their assistance in getting the Case Study so nicely formatted.
我們也要感謝 Anjali Kataria 發起這個案例研究。生物技術工作組也要感謝 Nancy Craighead, Andy Niedzielski 和 Orit Scharf 的MedImmune科學寫作團隊，在他們的幫助下，使得案例研究有如此優美的格式。
Finally, the CMC-BWG has requested that CASSS and ISPE place this document in the public domain. We thank these organizations for agreeing to host the case study and to continue with its use and development.
最後，CMC生物技術工作組已經要求CASSS和ISPE將這個文檔放在公共區域。我們感謝這些組織同意主辦這個案例研究，然後繼續其使用和發展。
The Facilitator Team 協調團隊: John Berridge, Ken Seamon, and Sam Venugopal