Process- and Product-Relate Impurities: Part 1 – Process-Related Impurities An Overview

Introduction by Cheryl Scott

The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of forum meetings are published in BioProcess International and on the CASSS website (www.casss.org). This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment will continue to be safe and efficacious.

This new special report series highlights a major subject area that has been covered over the first 10 years of the CMC Strategy Forum series: process-and product-related impurities. Appearing quarterly throughout 2016, these inserts will reprint four original articles along with updated discussions of their subject matter. We begin this month with a general overview of process-related impurities (1) and continue in April with an overview of product-related impurities.

This month’s installment comes from an early CMC Strategy Forum, which took place on 19–20 July 2004 and was originally published a year later as a four-part article in BPI. The first day of that conference focused on process-related impurities, with an overview in the morning and a specific session on host-cell proteins (HCPs) in the afternoon. That overview (Part 1) is reprinted in its entirety. Online you’ll find commentary from consultant Emily Shacter of ThinkFDA LLC (formerly of FDA CDER), who was one of the authors of Part 2 (which you can find online at www.casss.org/resource/resmgr/imported/2005SEP_BioProcess_Part2.pdf).

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Looking Ahead
Part 3 of “Defining Your Product Profile and Maintaining Control Over It” introduces product-related impurities, and Part 4 highlights concerns over aggregation. The former will be reprinted in its entirety in BPI’s April 2016 insert along with an executive summary of the latter. For the remainder of the year, whole reports will be featured on extractables and leachables (September 2016) and the immunogenic potential of aggregates and particles (November 2016). We will also include commentary from authors or other industry experts to update these discussions.

Our thanks go out to Karen Bertani of CASSS, an international separation science society, as well as the forum series program committee (left), for trusting BPI as their publishing partner in this endeavor. The CMC Strategy Forum series is ongoing. For information on upcoming meetings — in the United States, Europe, Japan, and Latin America — see the CASSS website.

Reference
1 Simmerman H, Donnelly RP. Defining Your Product Profile and Maintaining Control Over It, Part 1: Session One of the WCBP CMC Strategy Forum, 19–20 July 2004. BioProcess Int. 3(6) 2005: 32–40. •

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