Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products

Abstract

Investigational new drug applications (INDs) for novel cell therapy products require written documentation not only of the proposed clinical protocol and specific product manufacturing process, but also of information on items that may be generic for all products manufactured within a given facility. For facilities supporting multiple IND-related protocols, this generic information can be organized into a Drug Master File (DMF). This chapter will discuss the rationale, design, maintenance, and use of a DMF, either as an official submission to the U.S. Food and Drug Administration, or as an internal reference document that compiles information for subsequent extraction and incorporation into IND submissions.