Anthony Mire-Sluis, Sarah Kennett, Siddharth J. Advant, Cristina Ausin-Moreno, Barry Cherney, Steven Falcone, Jie He, Alexey Khrenov, Michael Tarlov, Kim Wolfram, Author at BioProcess InternationalBioProcess International

Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 2: Process Modeling and Analytics

by Anthony Mire-Sluis, Sarah Kennett, Siddharth J. Advant, Cristina Ausin-Moreno, Barry Cherney, Steven Falcone, Jie He, Alexey Khrenov, Michael Tarlov and Kim Wolfram

Part 1 of this article focused on the first two sessions of a CASSS chemistry, manufacturing, and controls (CMC) forum entitled “Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies,” which took place on 16–17 July 2018 in Gaithersburg, MD. Those sessions focused on upstream and downstream process technologies and strategies (1). Part 2 highlights the final two conference sessions on process modeling, control, and analytics. Process Modeling and Control The third conference session was “Modeling and Control Strategies.” Advancements in…

Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies, Part 1: Upstream and Downstream Strategies

by Anthony Mire-Sluis, Sarah Kennett, Siddharth J. Advant, Cristina Ausin-Moreno, Barry Cherney, Steven Falcone, Alexey Khrenov, Jie He and Kim Wolfram

Future biomanufacturing must address industry drivers, including the need for decreasing cost of goods (CoG), increasing market globalization, shortening development time for pipeline products, reducing risk to patient supply, and improving product quality. A CASSS chemistry, manufacturing, and controls (CMC) forum entitled “Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies” took place on 16–17 July 2018 in Gaithersburg, MD, to address those opportunities. Advanced technologies include single-use bioreactors, alternating tangential-flow (ATF) systems used during fermentation, modular and closed process equipment,…

CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations

by Siddharth J. Advant, Jee Chung, Gary Hartman, Mark H. Lee, Lana Shiu, John Towns, Sarah Kennett and Andrew Weiskopf

On 26 January 2015, CASSS hosted a program in its ongoing series of semiannual Chemistry, Manufacturing, and Controls (CMC) Strategy Forums at the Mayflower Hotel in Washington, DC. Since this series’s inception in 2002, each installment has focused on one of a wide array of topics spanning the fields of biopharmaceutical product development, manufacturing, analysis, quality, and regulation. For this forum, the program committee chose to devote a full program to a topic that was previously the focus of an…

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…

Effective Management of Contract Organizations: Keeping the Product Pipeline Moving, Compliant, and Available

by Anthony Mire-Sluis, Julia Edwards, Jeffrey Staecker, Qiao Bobo, Patricia Hughes, Stephen Liewbowitz, Shawn Novick, Siddharth J. Advant and Bernard Huyghe

Both small and large biopharmaceutical companies are increasingly pursuing the outsourcing of manufacturing and testing throughout the product lifecycle. The growing use of contract manufacturing organizations (CMOs) and contract testing organizations (CTOs) has led to increasing complexity within the biopharmaceutical industry as more third-party sites are leveraged to support global markets. To address those issues, a CASSS Chemistry, Manufacturing, and Controls (CMC) Strategy Forum was held in Washington, DC, 27–28 July 2014. The title was “Effective Management of Contract Organizations: Sponsors, Contract Organizations, Health Authorities and Patients — Keeping the Product Pipeline Moving, Compliant, and Available.” The CMC Strategy Forum is…

Multiproduct Facility Design and Control for Biologics: Challenges and Considerations

by Bo Chi, Julia Edwards, Jun Park, Stefanie Pluschkell, Nancy Waites, Elizabeth Yamashita, Siddharth J. Advant, Wassim Nashabeh and Lorna McLeod

Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a variety of…

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: Siddharth J. Advant