This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of ...

This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the regulatory processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product for commercial distr...