All About Cmc Manufacturing

In recent years the Food and Drug Administration (FDA) has worked to clarify its approach to the regulation of products that are comprised in whole or in part of living cellular materials. In fact the FDA issued a notice in the Federal Register as of October of 1993 which entitled, “Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Cell Therapy Products". This explained the regulatory frame work for somatic cell and gene therapy products. However this does not provide detailed technical guidance.

The May of 1996 guidance document describes the regulatory requirements that include clinical studies that are needed for market approval of a subset of autologous somatic cell therapy product. This area is called manipulated autologous structural cell products (MAS cell products.)

In the May 1996 guidance document it states that the biologics license application (BLA) may be submitted in lieu of the product license application (PLA) and an establishment license application (ELA). This document is used to provide guidance to manufacturers in the preparation of the chemistry, manufacturing and controls (CMC).

In part one of this guidance it describes the information that is to be submitted in the cmc information section of applications for autologous somatic cell therapy products. In part two of this guidance it includes a description of the information on the establishment that should be included in the establishment description section of the application.

Advice to the pharmaceutical industry in regards to the chemistry, manufacturing, and controls and microbiology (sterility assurance) information to be included in the regulatory submissions to the Center for Drug Evaluation and Research (CDER) can be located in the pertinent statutes, and regulations.

Neither the Act nor the regulations provide enough detail on the information that should already be included in these submissions. During the last fourteen years the CDER has issued a series of guidelines which provide specific detail related to the recommended filing mechanisms and information that CDER expects applicants to provide.