Joseph Kutza, PhD, Julia Edwards, Emanuela Lacana, Michelle Frazier, Ingrid Markovic, Demetra Macheras, Kim Wolfram, Author at BioProcess InternationalBioProcess International

Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)

by Joseph Kutza, PhD, Julia Edwards, Emanuela Lacana, Michelle Frazier, Ingrid Markovic, Demetra Macheras and Kim Wolfram

In the current global regulatory environment, management and implementation of postapproval CMC changes often can be unpredictable and inefficient. Timelines for change approval can vary from months to years, depending on regional regulatory procedures. Therefore, the challenge in postapproval lifecycle management is to maintain a constant supply of high-quality product while supporting innovation and continual improvement. This was the premise of the CASSS Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held in Gaithersburg, MD, on 20–21 July 2016. The forum…

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…

Expanded Change Protocols: Benefits, Cost Considerations, and Regulatory Views

by Nadine Ritter, Julia Edwards, Stefanie Pluschkell, Suzanne Stella, Rebekah Logan, Chana Fuchs, Wassim Nashabeh and Rohin Mahtre

The US FDA Office of Biotechnology Products’ quality by design (QbD) pilot program defines an expanded change protocol (eCP) as a particular type of comparability protocol that will “describe the quality by design, risk- based approach linking attributes and processes to product performance safety, and efficacy” (1). Sponsors have explored a wide range of potential applications for eCPs (e.g., movement within or beyond an established design space, site transfers, and additional process modifications supported by either a QbD or traditional…

Multiproduct Facility Design and Control for Biologics

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

Covering the whole development process for the global biotechnology industry