Regulatory Affairs Archives - Page 9 of 26 - BioProcess InternationalBioProcess International

Managing Customer and Regulatory Expectations

Partnering with a contract development and manufacturing organization (CDMO) allows drug-product sponsors to turn fixed costs into variable costs. Market forecasting by pharmaceutical companies drives numerous decisions in development programs: sales-force resources, geographic resource distribution, and (of course) manufacturing planning. It is a widely accepted fact in the pharmaceutical industry that accurate forecasting is a challenge, especially for new drug launches. A number of models can be used to develop drug forecasts, but none of these models is perfect. No…

Quality By Design for Monoclonal Antibodies, Part 2: Process Design Space and Control Strategies

by Brendan Cooney, Susan Dana Jones and Howard L. Levine

Process design space and control strategy are two fundamental elements of quality by design (QbD) that must be established as part of biopharmaceutical development and regulatory filings. Like all of QbD, they are interconnected and iterative. Both are based on knowledge gained during product and process development — but both need to be in place (in a potentially very limited form) when a company begins to manufacture drug substance for clinical trials. Part 1 of this discussion appears on pages…

Regulating Quality in Continuous Processing

by Mike Quesenberry and James Hathcock

Regardless of the industry and product being manufactured, continuous processing has demonstrated numerous benefits. In addition to smaller manufacturing footprints, reduced material consumption and waste generation, increased efficiencies, and lower capital and operating costs continuous manufacturing typically leads to more consistent processes and product quality. In the pharmaceutical industry, the latter two attributes align perfectly with FDA’s Quality by Design (QbD) and process analytical technology (PAT) initiatives. The challenge is determining how to apply these concepts in practice. Applying the…

Quality By Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development

by Brendan Cooney, Susan Dana Jones and Howard L. Levine

The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate as well as improve manufacturing processes within defined ranges without obtaining regulatory approval first. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials affects a final product (1). Historically, product quality has been assured either with end-product testing…

A Turning Point for US Biosimilars

by Carlos Angulo

The next 12–18 months could be a critical time for biosimilars in the United States (1). This product class has grown rapidly since passage of the Biosimilars Price Competition and Innovation Act (BPCIA) of 2010. That landmark legislation allowed for biosimilar market approvals based on previously approved “reference products,” creating an expedited pathway that reduces biosimilar development costs and speeds regulatory review so patients get faster access to essential medicines. Increased competition from biosimilars could save the US healthcare system…

Automation of CAR-T Cell Adoptive Immunotherapy Bioprocessing: Technology Opportunities to Debottleneck Manufacturing

by David A. Brindley, James A. Smith, Brock Reeve, Kim Bure, Zeeshaan Arshad, Franziska Faulstich, David Pettitt, Georg Holländer, Andrew Ball, Kiara Biagioni, Sunil Mehta, Rajan Choudhary and Hussein Al-Mossawi

Continued clinical efficacy demonstrations of cell-based immunotherapies (iTx) such as chimeric antigen receptor T cell (CAR-T) therapies has made the prospect increasingly likely of an immunotherapy product achieving conditional market authorization in the short term. For example, Novartis and the University of Pennsylvania’s lead candidate (CTL019) for treating a range of hematological malignancies received breakthrough status from the US Food and Drug Administration (FDA) in 2014, permitting access to an expedited drug development pathway for high unmet medical needs (1).…

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…

Addressing Variability in Product Labeling: Explore Dynamic Labeling for Your Global Enterprise

by Mike Ward

Adding to the complexity of drug-product labeling, companies face a broad range of evolving requirements. Those include regional, language, customer, and regulatory requirements that must be met quickly and efficiently to prevent supply-chain disruption. Companies that cannot meet those requirements can end up with fines, dissatisfied customers, and loss of business. Enterprise labeling solutions allow drug makers to deal with variability in labeling by providing label formatting that supports myriad different label combinations with a minimum number of label designs.…

The Year of Data Integrity: 2015 Brought a Worldwide Focus on Training, System Design and Control, and Data Management

by Doug Chambers

Each year, regulatory agencies from around the world focus on critical aspects of the pharmaceutical quality management system, bringing awareness to the industry and continuing to effect positive change. In the past five years, risk assessments, electronic records, and outsourced activities have been in the spotlight. As 2015 closed out, it was clearly the year of data integrity. In March 2015, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published its GMP Data Integrity Definitions and Guidance for Industry,…

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…