PDA TR从初创到商业化的生物制药制造Manufacturing Biopharmaceuticals.pdf

Manufacturing Biopharmaceuticals from Start-up to Commercialization 生物制药从初创到商业化生产制造 Joseph Waggett and Laura Grayson Roselli This chapter is reprinted from Biotechnology From Idea to Market with permission. All rights reserved 10 9 8 7 6 5 4 3 2 1 ISBN: 978-1-942911-37-1 Copyright © 2019 Fred Mermelstein, Richard Prince and Carl Novina All rights reserved. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system or transmitted in any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Printed in the United States of America. Where a product trademark, registration mark, or other protected mark is made in the text, ownership of the mark remains with the lawful owner of the mark. No claim, intentional or otherwise, is made by reference to any such marks in the book. Websites cited are current at the time of publication. The authors have made every effort to provide accurate citations. If there are any omissions, please contact the publisher. While every effort has been made by the publisher and the authors to ensure the accuracy of the information expressed in this book, the organization acecpts no responsibility for errors or omissions. The views expressed in this book are those of the authors and may not represent those of either Davis Healthcare International or the PDA, its officers, or directors. PDA Global Headquarters Davis Healthcare International Publishing, LLC Bethesda Towers, Suite 150 2636 West Street 4350 East-West Highway River Grove Bethesda, MD 20814 IL 60171 United States