ISBN-13: 9781439829455 / Angielski / Twarda / 2011 / 328 str.
ISBN-13: 9781439829455 / Angielski / Twarda / 2011 / 328 str.
This text summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations.