This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

The first edition of this book was the seminal book on pharmaceutical extrusion, focusing on extrusion as a manufacturing methodology for dosage forms. In the past 10 years, extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients. This acceptance has resulted in many hardware and process advancements which have been highlighted in this second edition. The book brings together all extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms.

When a biological drug patent expires, alternative biosimilar products are developed. Biological drugs are different in many respects from drugs based on chemically synthesized small molecules. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is complicated and difficult. This book presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and post-approval issues.