AAPS Advances in the Pharmaceutical Sciences Series

Volume 18

Series Editors Daan J. A. Crommelin Utrecht, Utrecht, The Netherlands

Robert A. LipperBack Cove Pharma, LLC, Waldoboro, Maine, USA

The AAPS Advances in the Pharmaceutical Sciences Series, published in partner-ship with the American Association of Pharmaceutical Scientists, is designed to de-liver well written volumes authored by opinion leaders and authorities from around the globe, addressing innovations in drug research and development, and best prac-tice for scientists and industry professionals in the pharma and biotech industries.

More information about this series at http://www.springer.com/series/8825

Feroz Jameel • Susan Hershenson Mansoor A. Khan • Sheryl Martin-MoeEditors

Quality by Design for Biopharmaceutical Drug Product Development

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ISSN 2210-7371 ISSN 2210-738X (electronic)AAPS Advances in the Pharmaceutical Sciences SeriesISBN 978-1-4939-2315-1 ISBN 978-1-4939-2316-8 (eBook)DOI 10.1007/978-1-4939-2316-8

Library of Congress Control Number: 2015934451

Springer New York Heidelberg Dordrecht London© Springer Science+Business Media, LLC 2015This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed.The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use.The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made.

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EditorsFeroz JameelParenteral Product and Process DevelopmentAmgen Inc.Thousand OaksCaliforniaUSA

Susan HershensonBill and Melinda Gates Foundation, Chemistry, Manufacturing and ControlsSeattleWashingtonUSA

Mansoor A. KhanDivision of Product Quality ResearchFood and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research and Office of Pharmaceutical SciencesSilver SpringMarylandUSA

Sheryl Martin-MoeEnterprise Catalyst Group Inc.Palo AltoCaliforniaUSA

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This work is dedicated to the memory of our friend and colleague Ronald Taticek as a tribute to the imagination that led him to undertake a project of this magnitude and made him a pioneer in this field. It is also a tribute to the dedication that inspired Ron to carry this effort so far to completion before he passed away on April 23, 2014. Ron will be greatly missed.

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Preface

Occasionally in one’s professional career you become aware that the hand of history is resting on your shoulder. So it was in July 2003, in Brussels, when the members of the International Conference on Harmonisation (ICH) Expert Working Groups (EWG) for quality agreed on a new vision and strategy for ICH. Summarized in the statement, “A harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk manage-ment and science,” ICH agreed to progress three paradigm-changing guidelines. These were Q8 (pharmaceutical development), Q9 (quality risk management), and Q10 (pharmaceutical quality system). When I called to order the first Q8 EWG, we all thought that we might be able to take the existing European Note for Guidance on Development Pharmaceutics and convert it into an appropriate ICH format and that would be it: a simple task. It took us a little while to appreciate the futility of this approach, especially given the growing interest in the application of process analytical technology (PAT) and the growing appreciation that the goal of pharma-ceutical development is to design a quality product and its manufacturing process to deliver consistently the intended performance of the product. The only way to achieve that consistency would be by designing a product from the outset that would meet patients’ needs, acquiring comprehensive product and process understanding, and establishing a properly controlled manufacturing process. We needed to tell the world that quality cannot be tested into a product; it has to be designed into a product. But, of course, everyone already knew this, so there was nothing new here, but how could we help move the industry from its traditional 3-sigma processes toward 6-sigma? We needed to talk about Deming, Juran, kaizen, risk assessments, experimental designs, even the value of “failed” experiments. We needed to give the industry permission to share the fullness of their scientific knowledge without the fear of creating an ever-increasing list of regulatory questions that added little value but much time to the review and approval processes.

With these things in mind, the EWG drafted the ICH Q8 guideline. Recognizing that traditional development processes would still be needed, we referred to the new thinking as an “enhanced approach,” deliberately avoiding the moniker of “quality by design.” Even as Q8 went through its final revisions and adoption, it became clear that outside the confines of the EWG, neither the industry nor regulators had a clear understanding of the new paradigm. We were asked to use the addendum to

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Q8 to define and exemplify “quality by design,” and we did our best, comparing traditional approaches with an enhanced quality-by-design approach. But even with this effort, and with subsequent Implementation Working Group efforts (which have included question and answer documents, points to consider), there is still mystery and confusion about what QbD really means for the pharmaceutical industry.

Fortunately, our journey has been helped by the foresight and commitment of a number of early adopters. Before the ink was dry on the first part of Q8, a team within the European Federation of Pharmaceutical Industries and Associations de-veloped a mock section P2 (Examplain), which demonstrated some of the key ele-ments of QbD including a quality target product profile, risk assessments, design of experiments, and design space. Two more comprehensive case studies, intended for discussion and teaching purposes, quickly followed. The first, ACE tablets, was aspirational in many respects and explored a number of innovative concepts that industry was contemplating. The second, A-Mab, discussed the application of QbD principles to a biotechnology product, stimulating much discussion between indus-try and regulators at the same time as the FDA was introducing its pilot programs. Other case studies such as the Sakura mock P2 from Japan and A-Vax (QbD for vaccines) and the several mock ANDA submissions have strengthened our under-standing and appreciation of both business and regulatory opportunities.

Many would regard QbD for chemical substances as straightforward: our under-standing of kinetics and thermodynamics enables rapid building on prior knowledge to provide scalable syntheses. On the other hand, drug product development still remains a complex blend of art and science which may be behind the often expe-rienced challenges of establishing well characterized, robust manufacturing pro-cesses that can be described by reliable models. For biologics, it could be argued that the opposite situation pertains. The drug substance is the process: the processes are often exquisitely designed and engineered with feed-forward and feedback con-trol strategies. While the quality is designed from the outset, the many degrees of freedom and the characterization challenges mean that full application of QbD prin-ciples is not easy. The list of critical quality attributes is generally extensive, our ability to directly connect them through analytical techniques back to the critical process parameters and forward to the patient is often not straightforward, and the realization of design spaces becomes challenging, especially when you consider the risks associated with movement with a design space. However, application of QbD principles to the final steps, the drug product, is much more straightforward.

Into one insightful volume is collected a wide range of discussions and prac-tical examples of the application of QbD to biological drug products. For those still uncertain about the business benefit, this is the area to start. Biological drug product manufacturing processes lend themselves to the enhanced approach. The risks, science and engineering are all much better understood than those in many other areas of our industry. The degrees of freedom are manageable. QbD prin-ciples facilitate developing an effective control strategy, arguably the most critical deliverable of a well planned and executed development program, including real-time release-testing opportunities.

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Most of the leading pharma companies now consider QbD to be “business as usual” for the current development portfolio. An increasing number of publications attest to the business benefits that have accrued from QbD programs and filings. Experience is growing with successful regulatory submissions and approvals. For sure, both industry and agencies have been on a steep learning curve with the new paradigm, but in the USA, the small molecule pilot program followed by the bio-logics pilot program have provided valuable insight and learning. Similar initiatives have occurred elsewhere. The international agencies have mounted joint assessment and inspection programs—our new paradigm is here to stay, and the publication of this book could not be better timed. Now is the time to wholeheartedly grasp the op-portunities, to do the great science that surely motivates us all and comprehensively tell the story to the regulators. What are you afraid of? The patient is waiting.

John Berridge, Kent, UK(john.berridge@orange.net)

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Contents

1 Challenges and Opportunities for Biotech Quality by Design ............... 1Cyrus Agarabi, Mansoor A. Khan and Rakhi B. Shah

2 Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program ...................................................................................................... 17Barbara L. Rellahan, Steven Kozlowski and Patrick Swann

3 Definitions and Scope of Key Elements of QbD ...................................... 31Ron Taticek and Jun Liu

4 An Overview of Quality by Design for Drug Product ............................. 47Sheryl Martin-Moe and Carol Nast

5 Development of Drug Product Formulations: Molecular Design and Early Candidates Screening .................................................. 61Michael Siedler, Vineet Kumar, Ravi Chari, Sonal Saluja and Wolfgang Fraunhofer

6 Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations .............................. 87Bernardo Perez-Ramírez, Nicholas Guziewicz, Robert Simler and Alavattam Sreedhara

7 Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products ........................................... 115Alavattam Sreedhara, Rita L. Wong, Yvonne Lentz, Karin Schoenhammer and Christoph Stark

8 Application of QbD Principles for Lyophilized Formulation Development ............................................................................................... 137Ambarish Shah, Sajal M. Patel and Feroz Jameel

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9 Drug Substance Frozen Storage and Thawing ........................................ 159Philippe Lam, Fredric J. Lim and Samir U. Sane

10 Quality by Design as Applied to Drug Substance Formulation Using Ultrafiltration and Diafiltration .............................. 191Joseph Edward Shultz, Herb Lutz and Suma Rao

11 A QbD Approach in the Development and Scale-Up of Mixing Processes ......................................................................................... 211Feroz Jameel and Sonja Wolfrum

12 Application of QbD Elements in the Development and Scale-Up of a Commercial Filtration Process .......................................... 237Feroz Jameel

13 Application of QbD Elements in the Development and Scale-up of Commercial Filling Process ................................................... 265Feroz Jameel, Cenk Undey, Paul M. Kovach and Jart Tanglertpaibul

14 Lyophilization Process Design and Development Using QbD Principles .................................................................................................... 303Sajal M. Patel, Feroz Jameel, Samir U. Sane and Madhav Kamat

15 Visible and Subvisible Protein Particle Inspection Within a QbD-Based Strategy .................................................................................. 331Erwin Freund and Shawn Cao

16 Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products .......................................................... 353Paul Harber

17 Quality by Design for Primary Container Components ......................... 365Fran DeGrazio and Lionel Vedrine

18 Devices and Combination Products for Biopharmaceuticals ................ 403Rey T. Chern, Jeffrey C. Givand, Robin Hwang and Thomas J. Nikolai

19 Applicability of QbD for Vaccine Drug Product Development .............. 437Liuquan (Lucy) Chang, Jeffrey T. Blue, Joseph Schaller, Lakshmi Khandke and Bruce A. Green

20 Automation and High-Throughput Technologies in Biopharmaceutical Drug Product Development with QbD Approaches ................................................................................................. 475Vladimir Razinkov, Jerry Becker, Cenk Undey, Erwin Freund and Feroz Jameel

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21 Critical Quality Attributes, Specifications, and Control Strategy......... 511Timothy Schofield, David Robbins and Guillermo Miró-Quesada

22 Multivariate Analysis for Process Understanding, Monitoring, Control, and Optimization of Lyophilization Processes ... 537Theodora Kourti

23 Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-Drying Processes .............................................................. 565Davide Fissore, Roberto Pisano and Antonello A. Barresi

24 Application of Multivariate Statistical Process Monitoring to Lyophilization Process ............................................................................... 595Fuat Doymaz

25 Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process ........................................................................... 605Feroz Jameel, William J. Kessler and Stefan Schneid

26 Product Homogeneity Assessment During Validation of Biopharmaceutical Drug Product Manufacturing Processes ................ 649Fuat Doymaz, Frank Ye and Richard K. Burdick

27 Application of Quality by Design Principles to the Drug Product Technology Transfer Process ...................................................... 661Fredric J. Lim, Jagannathan Sundaram and Alavattam Sreedhara

28 Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management.......................................................... 693Lynne Krummen

Index .................................................................................................................. 707

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Contributors

Cyrus Agarabi Division of Product Quality Research, Office of Testing and Research and Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

Antonello A. Barresi Dipartimento di Scienza Applicata e Tecnologia, Politecnico di Torino, Torino, corso Duca degli Abruzzi 24, Italy

Jerry Becker Drug Product Development, Amgen Inc., Seattle, WA, USA

Jeffrey T. Blue Vaccine Drug Product Development, Merck, West Point, PA, USA

Richard K. Burdick Amgen Inc. One Amgen Center Drive, Longmont, CO, USA

Shawn Cao Process and Product Development, Amgen Inc., Thousand Oaks, CA, USA

Liuquan (Lucy) Chang Biopharm Development, Vaccine Research & Early Development, Pfizer Inc., Teva Biopharmaceuticals, Rockville, MD, USA

Ravi Chari Preformulation, Bioresearch Center, AbbVie, Worcester, MA, USA

Rey T. Chern Merck Manufacturing Division, Pharmaceutical Packaging Tech-nology & Development, West Point, PA, USA

Fran DeGrazio Global R & D, Strategic Program Management and Technical Customer Support, West Pharmaceutical Services, Exton, PA, USA

Fuat Doymaz Global Quality Engineering, Amgen Inc., Thousand Oaks, CA, USA

Davide Fissore Dipartimento di Scienza Applicata e Tecnologia, Politecnico di Torino, Torino, corso Duca degli Abruzzi 24, Italy

Wolfgang Fraunhofer Combination Products-Biologics, Drug Product Develop-ment, AbbVie, Chicago, IL, USA

Erwin Freund Parenteral Product and Process Development, Amgen, Inc., Thousand Oaks, CA, USA

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Jeffrey C. Givand Device Development, Merck Research Laboratories, West Point, PA, USA

Bruce A. Green Vaccine Research and Early Development, Pfizer, Pearl River, NY, USA

Nicholas Guziewicz Drug Product Process Technology, Amgen Inc., Thousand Oaks, CA, USA

Paul Harber Modality Solutions, LLC, Indianapolis, IN, USA

Robin Hwang ICP Consulting Corp., Thousand Oaks, CA, USA

Feroz Jameel Parenteral Product and Process Development, Amgen Inc., Thousand Oaks, CA, USA

Drug Product Engineering, Amgen, Inc., Thousand Oaks, CA, USA

Madhav Kamat Bristol-Myers Squibb, New Brunswick, NJ, USA

William J. Kessler Physical Sciences Inc., Andover, MA, USA

Mansoor A. Khan Division of Product Quality Research, Office of Testing and Research and Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

Lakshmi Khandke Vaccine Research and Early Development, Pfizer, Pearl River, NY, USA

Theodora Kourti Global Manufacturing & Supply, GSK, London, UK

Paul M. Kovach Drug Product Commercialization Technology Center, Manu- facturing Science and Technology, Eli Lilly and Company, Indianapolis, IN, USA

Steven Kozlowski Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA

Lynne Krummen Regulatory Affairs Department, Genentech, South San Francisco, CA, USA

Vineet Kumar Pharmaceuticals, Johnson and Johnson, Malvern, PA, USA

Philippe Lam Pharmaceutical Processing and Technology Development, Genentech, San Francisco, CA, USA

Yvonne Lentz Global Manufacturing Sciences and Technology Biologics, Genentech, San Francisco, CA, USA

Fredric J. Lim Pharmaceutical Processing and Technology Development, Gene- ntech, South San Francisco, CA, USA

Jun Liu Pharma Technical Operations, Development, Genentech Late Stage Pharmaceutical Development, San Francisco, CA, USA

xviiContributors

Herb Lutz Biomanufacturing Sciences Network, EMD Millipore Corp., Darmstadt, Germany

Sheryl Martin-Moe Enterprise Catalyst Group Inc., Palo Alto, CA, USA

Guillermo Miró-Quesada Quantitative Sciences, MedImmune, Gaithersburg, MD, USA

Carol Nast Enterprise Catalyst Group Inc., Palo Alto, CA, USA

Thomas J. Nikolai Biologics Processing Development, Hospira, Lake Forest, IL, USA

Sajal M. Patel Formulation Sciences, Biopharmaceutical Development, MedIm-mune, Gaithersburg, MD, USA

Bernardo Perez-Ramírez BioFormulations Development, Global Biotherapeutics, Sanofi Corporation, Framingham, MA, USA

Lynn Phelan Vaccine Research and Early Development, Pfizer, Pearl River, NY, USA

Roberto Pisano Dipartimento di Scienza Applicata e Tecnologia, Politecnico di Torino, Torino, corso Duca degli Abruzzi 24, Italy

Suma Rao Process and Product Development, Amgen Inc, Thousand Oaks, CA, USA

Vladimir Razinkov Drug Product Development, Amgen Inc., Seattle, WA, USA

Barbara L. Rellahan Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA

Amgen Inc., Rockville, MD, USA

David Robbins Purification Process Sciences, MedImmune, Gaithersburg, MD, USA

Sonal Saluja Bioresearch Center, AbbVie, Worcester, MA, USA

Samir U. Sane Pharmaceutical Processing and Technology Development, Genentech, San Francisco, CA, USA

Samir U. Sane Pharmaceutical Development, Genentech, San Francisco, CA, USA

Joseph Schaller Sterile/Liquids Commercialization, Merck, West Point, PA, USA

Stefan Schneid Syntacoll GmbH, Saal, Germany

Karin Schoenhammer Technical Research and Development, Biologics, Novartis Pharma AG, Basel, Switzerland

Timothy Schofield Regulatory Sciences & Strategy, Analytical Biotechnology, MedImmune, Gaithersburg, MD, USA

xviii Contributors

Ambarish Shah Formulation Sciences, Biopharmaceutical Development, MedIm-mune, Gaithersburg, MD, USA

Rakhi B. Shah Division of Product Quality Research, Office of Testing and Research and Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

Joseph Edward Shultz Biologics Process Research and Development, Novartis Pharma AG, Basel, Switzerland

Michael Siedler NBE Formulation Sciences & Process Development, AbbVie, Ludwigshafen, Germany

Robert Simler Formulation and Process Development, Biogen Idec., Cambridge, MA, USA

Alavattam Sreedhara Late Stage Pharmaceutical Development, Genentech, San Francisco, CA, USA

Christoph Stark Technical Research and Development, Biologics, Novartis Pharma AG, Basel, Switzerland

Jagannathan Sundaram Global Biologics Manufacturing Science and Technology, Genentech, San Francisco, CA, USA

Patrick Swann Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA

Biogen Idec, Cambridge, MA, USA

Jart Tanglertpaibul Drug Product Commercialization Technology Center, Manufacturing Science and Technology, Eli Lilly and Company, Indianapolis, IN, USA

Ron Taticek Pharma Technical Operations, Biologics, Genentech Vacaville Operations, South San Francisco, CA, USA

Cenk Undey Process Development, Amgen Inc, Thousand Oaks, CA, USA

Lionel Vedrine Device Development, Genentech, San Francisco, CA, USA

Sonja Wolfrum Institute of Particle Technology, University of Erlangen-Nuremberg, Erlangen, Germany

Rita L. Wong Global Manufacturing Sciences and Technology Biologics, Genentech, South San Francisco, CA, USA

Frank Ye Amgen Inc. One Amgen Center Drive, Thousand Oaks, CA, USA

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About the Editors

Dr. Feroz Jameel is a Principal Scientist for Parenteral Product & Process Development at Amgen Inc., in Thousand Oaks, CA, where he is involved in the development, optimization, scale-up and transfer to manufacturing of biopharmaceutical products. Feroz received his Master’s degree in Pharmaceutics from the University of Delhi and his Ph.D in Pharmaceutics from the University of Connecticut. His publications include a co-edited book, several book chapters and more than 40 peer-reviewed manuscripts and presentations. He has held multiple leadership positions at the American Association of Pharmaceutical Scientists (AAPS) including chair of the freezing and drying technologies group and lead of the industrial consortium for application of QbD to lyophilization. He is a recipient of two patents in lyophilization formulation and lyophiliztion process development. Dr. Jameel has received several awards including the AAPS and Parental Drug Association’s Fred Simon Award for the best paper published in the Journal of Pharmaceutical Science and Technology. He has also chaired several symposia on the development of biological products.

Dr. Susan A. Hershenson is the Deputy Director of Chemistry, Manufacturing and Controls at the Bill and Melinda Gates Foundation, where her major responsibilities are to support the CMC development and drug delivery needs for therapeutic projects funded by the Foundation. She has many years of experience in drug development, including biologics, small molecules, combination products and drug delivery systems. Prior to the Gates Foundation, she served as President of Pharmaceutical Transformations LLC, a consulting service for the pharmaceutical, biotechnology, drug delivery and related industries. Her clients included a wide range of biotechnology, pharmaceutical and drug delivery companies, start-ups, venture capitals, university labs and non-profit organizations. Before starting her own practice, she served in a number of positions in the biopharmaceutical industry, including Vice President of Pharmaceutical and Device Development at Genentech and Vice President of Pharmaceutics at Amgen. During her career, Dr. Hershenson has made significant contributions to the development and commercialization of numerous therapeutic products including BETASERON®, Stemgen®, Kepivance®, Aranesp®, Neulasta®, Sensipar®, Nplate®, Vectibix®, Prolia®, XGEVA® and

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Nutropin AQ NuSpin® and has supported the development of numerous clinical candidates. She received her Ph.D. in Biochemistry from Yale University and held a postdoctoral fellowship in the laboratory of Dr. Robert Stroud at the University of California, San Francisco. Dr. Hershenson publishes and teaches actively and serves on multiple scientific advisory boards.

Dr. Mansoor A. Khan is the Director of Product Quality Research and a Senior Biomedical Research Scientist at the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), where he overseas research teams on biotech products, chemistry and stability, drug delivery systems and bioavailability/bioequivalence. Prior to joining the FDA, he was a Professor of Pharmaceutics and Director of the graduate program in the School of Pharmacy at Texas Tech University Health Sciences Center. He is a registered pharmacist and earned his Ph.D. in Industrial Pharmacy from the St. John’s University School of Pharmacy. He has published more than 255 peer-reviewed manuscripts, four texts, 25 book chapters, 200 poster presentations, and more than 175 invited presentations worldwide. He has held several leadership positions at the American Association of Pharmaceutical Scientists (AAPS) including elected chair of pharmaceutics and drug delivery (PDD) and the founding chair of formulations design and development (FDD). He serves on the editorial board of Pharmaceutical Technology, the International Journal of Pharmaceutics, AAPS Pharmsci Tech, and Drug Delivery and Translational Research. He has received the AAPS Research Achievement Award in Formulations Design and Development and is an AAPS Fellow

Dr. Sheryl Martin-Moe is an Executive Vice President at Enterprise Catalyst Group in Palo Alto, CA, where she consults for biotechnology, pharmaceutical and related companies and serves on scientific advisory boards. She has managed the development of more than 90 diverse drugs and combination products. She received her Ph.D. in Cell Biology from the University of Vermont and was a postdoctoral fellow in Biochemistry at the University of California, Berkeley. She worked at Sterling Drug in its research division and held management positions in various Development and Operation areas at Centocor, Bayer, and Genentech and was most recently Global Head of Pharmaceutical Development at Novartis Biologics in Basel, Germany. Her publications include two patents, two book chapters and 21 publications and invited presentations, including a publication that won the Parenteral Drug Association’s Fred Simon Award. Dr. Martin-Moe was a member of the CMC Biotech Working Group and co-authored its A-Mab case study for QbD.

About the Editors