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CMC Forum: Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification

by JR Dobbins, Stefanie Pluschkell, Timothy Schofield, Philip Krause, Julia O'Neill, Patrick Swann and Joel Welch

As defined in the ICH Q10 guideline, a control strategy is “a planned set of controls, derived from current product and process understanding, that assures process performance and product quality” (1). Every biopharmaceutical manufacturing process has an associated control strategy. FDA’s 2011 guidance for process validation (2) describes process validation activities in three stages (Figure 1). A primary goal of stage 1 is to establish a strategy for process control that ensures a commercial process consistently produces acceptable quality products.…

Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and Aggregates

by Anthony Mire-Sluis, Stacey Ma, Ingrid Markovic, Lorna McLeod and 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…

Science, Risks, and Regulations: Current Perspectives on Host Cell Protein Analysis and Control

by Zahra Shahrokh, Dieter Schmalzing, Rashmi Rawat, Victoria Sluzky, Kowid Ho, Jorg Engelbergs, John Bishop, Erika Friedl, Bruce Meiklejohn and Nadine Ritter

State-of-the-art analytics guide process development by providing companies with thorough understanding, effective removal, suitable control, and comparability assessment after process changes of host cell proteins (HCPs) in recombinant biotechnology products. An array of analytical techniques and approaches can be used to establish control strategies for host cell proteins. Techniques used for HCP characterization and comparability include two-dimensional (2D) gel electrophoresis with a range of stains, 2D immunoblotting, 2D high-performance liquid chromatography (HPLC), 2D difference gel electrophoresis (DIGE), and increasingly mass…

CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview

by Cheryl Scott, Siddharth J. Advant, Yves Aubin, John Bishop, Barry Cherney, Anthony Mire-Sluis, JR Dobbins, Julia Edwards, Sarah Kennett, Joseph Kutza, PhD, Timothy Schofield, Kimberly May, Stefanie Pluschkell, Nadine Ritter, Reb Russell, Oscar Salas-Solano, PhD, Dieter Schmalzing, Zahra Shahrokh, Jeffrey Staecker and Andrew Weiskopf

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. This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment…

Defining Your Product Profile and Maintaining Control Over It | A Look Back with Emily Shacter

by Leah Rosin

This is a transcript from a Q&A interview with Emily Shacter, PhD, Consultant, ThinkFDA LLC (former FDA Scientist and Regulator). We will be talking today about the CMC Forum that was published back in 2005. We are revisiting it in the magazine to specifically update our understanding of how to maintain process control; understanding your process. In general, how do you feel the discussions in the four-part paper from 2005 has held up after 10 years? Emily: I think they…

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

by Heather Simmerman and Raymond P. Donnelly

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…

Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, 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 the 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…

Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality

by Ziping Wei, Emily Shacter, Mark Schenerman, John Dougherty and Lorna D. McLeod

Cosponsored by CASSS (an International Separation Science Society) and the US FDA, the 17th CMC Strategy Forum was designed to explore the relationships between higher-order molecular structure and quality of therapeutic proteins and peptides, vaccines, and blood-derived products. Understanding those relationships is important to defining and controlling the critical quality attributes (CQAs) of biopharmaceutical products. The forum program highlighted the current state of the art for analytical tools used to monitor higher-order structure. Case studies demonstrating the effects of changes…

Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase, and Postapproval

by John Towns Keith Webber

Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios (1). Development of flexible, comprehensive approaches in strategy development addressed evaluation of critical product characteristics, appropriate process steps to test, numbers of lots and levels of testing required, and assessment of product comparability. The…

Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Roles of Bioactivity Assays in Lot Release and Stability Testing

by Noel Rieder, Helene Gazzano-Santoro, Mark Schenerman, Robert Strause, Chana Fuchs, Anthony Mire-Sluis and Lorna D. McLeod

A January 2007 CMC Strategy Forum on the roles of bioactivity assays in lot release and stability testing was held in Washington, DC (1). Its purpose was to promote an understanding of the design and utility of bioassays throughout product development and to delineate the conditions under which surrogate assays could be used to determine product potency. Topics of discussion included appropriate assay selection at each stage of product development, the potential use of binding assays for potency testing, and…