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, Andrew Weiskopf, Author at BioProcess InternationalBioProcess International

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…

Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations

by Nadine Ritter, Reb Russell, Timothy Schofield, Laurie Graham, Paul Dillon, Frank Maggio, Lokesh Bhattacharyya, Dieter Schmalzing, Wei-Meng Zhou, Kenneth Miller and Harry Yang

To monitor the control and consistency of products derived from biological systems, a broad array of analytical methods are used for biopharmaceutical release and stability testing. These methods include both classical and state-of-the-art technologies as well as new technologies as they emerge over time.During the life cycle of a product, several reasons can arise for making changes in existing analytical methods: e.g., improved sensitivity, specificity, or accuracy; increased operational robustness; streamlined workflows; shortened testing times; and lowered cost of testing.…

New Paradigms for Process Validation

by Anthony Mire- Sluis, Vijay Chiruvolu, Brian Kelley, Linda Ng, Reb Russell, Chiang Syin, Victor Vinci, Mats Welin, Nathan McKnight, Bob Kuhn, Christian Klock, Ranjit Deshmukh and Siddharth J. Advant

Both the United States and the European Union have recently evolved guidance on how to execute process validation (1, 2) with the prospect of a more appropriate life-cycle approach. It goes beyond the traditional three to five lots run at the center point of proposed ranges for operating parameters. New approaches leverage product design and process development information. They facilitate adapting the quality by design (QbD) paradigm to allow for a science- and risk-based selection of critical process…

Covering the whole development process for the global biotechnology industry

Author Archives: Reb Russell

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

Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations

New Paradigms for Process Validation