Publisher's Synopsis
Most people who pick up this book have a scientific background, perhaps from a degree, perhaps after a few years in academia. They want to take this background and jump into the pharmaceutical industry, they might be thinking of quality assurance or production, maybe even regulatory affairs.
But it's not an easy jump to make. There is a vast step between the laboratory world and that of commercial manufacturing. It is a jump from plate readers and pipettes up to a world of thousand-litre fermenters and raw materials measured out by the tonne. A world where failure can cost millions and where anxious engineers sweat over the slightest variation in pH - and a world which most of us have never experienced before. Written for those still in academia or just having moved into industry, this book will introduce the art of developing and validating a commercial process - from making that initial design through to continuing process validation. It will guide you through the many steps involved while explaining the dense cloud of jargon. Sound useful? Then read on!
