ABSTRACT
Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 511 18.5 Process Changes and Product Comparability for Commercial
Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 515 18.5.1 Scale-Up and Post-Approval Changes . . . . . . . . . . . . . . . . . . . . . . . . 517
18.6 Regulatory Strategies to Support Process Changes . . . . . . . . . . . . . . . . . . . 519
SHUKLA: “dk3347_c018” — 2006/5/24 — 16:25 — page 508 — #2
The lifecycle for a biopharmaceutical manufacturing process begins with preclinical process development, followed by process scale-up and improvements through manufacturing campaigns for human clinical trial materials leading up to the licensed, commercial manufacturing process. After licensure, process changes may be required to accommodate further scale-up and improvements as well as transfer to new or additional manufacturing sites. The drug substance must be demonstrated to be comparable to provide an assurance that the safety and efficacy of the drug used by a patient is the same as that used in clinical trials and for which licensure was granted.
