Downloaded by 80.82.77.83 on May 19, 2018 | https://pubs.acs.org Publication Date: July 23, 1998 | doi: 10.1021/bk-1998-0698.pr001
Preface
T h e papers published in this volume were drawn from a session entitled Validation of Biopharmaceutical Manufacturing Processes held at the 1997 American Chemical Society National Meeting in San Francisco. The session was sponsored by the Division of Biochemical Technology. Attendance at the session was strong throughout the day, as eighteen papers were presented on many aspects of process validation. We believe this reflects the importance of validation in the licensure and manufacturing of biopharmaceuticals, including recombinant and non-recombinant proteins, vaccines, agents for genetic therapies, and carbohydrate-based drugs. These therapeutic agents and vaccines originate from biological processes, which may lead to a complex mixture of product isoforms; often, these are poorly characterized in comparison to low molecular weight compounds. This combination of biological complexity and variability during product synthesis and purification coupled with the difficulty in fully characterizing the product composition motivates extensive process validation of these processes. While the Food and Drug Administration and its international counterparts publish guidance on validation, these guidelines are general and require considerable interpretation. Various responses are possible given this incompletely defined mandate. Companies may seek to minimize the investment in validation studies, by identifying the minimally acceptable validation package. Alternatively, a validation master plan can grow to enormous proportions, as all possible studies are conducted in an effort to answer every conceivable validation question. Companies must remain focused on the primary motivation for completing a process validation package, which is to demonstrate both an understanding of the manufacturing process and how to control the process so that product of sufficient quality and yield is produced in a consistent manner. The application of sound scientific, engineering, and statistical methods are necessary to complete this task. The intent of this volume is to provide a forum for the presentation of various components of a process validation package. The papers address all aspects of biopharmaceutical manufacturing processes, including cell culture and fermentation, product purification, and fill-finish operations. A symposium series book of this size cannot possibly convey information on all topics required for ix
Kelley and Ramelmeier; Validation of Biopharmaceutical Manufacturing Processes ACS Symposium Series; American Chemical Society: Washington, DC, 1998.
complete process validation; however, we hope that this book is useful as a reference which provides insights into the design and execution of process validation studies from a number of companies, many of which hold licenses for the manufacture of biotherapeutics and vaccines. Acknowledgments
Downloaded by 80.82.77.83 on May 19, 2018 | https://pubs.acs.org Publication Date: July 23, 1998 | doi: 10.1021/bk-1998-0698.pr001
The editors thank all those who made oral presentations at the ACS meeting, and especially those who contributed manuscripts for this book. We recognize the sensitive nature of preparing material on process validation to be shared with a larger audience, and are deeply grateful to those who persevered through it all. We also thank the reviewers, whose efforts have assured that the chapters in this book are of the highest technical and compositional quality. B R I A N D. KELLEY
Genetics Institute, Inc. Andover, M A 01810 R. A N D R E W R A M E L M E I E R
Merck Research Laboratories West Point, PA 19486
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