Author Archives: Andrew Weiskopf

Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management

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This two-day CASSS CMC Strategy Forum explored many technical, practical, and regulatory facets of biological drug-product (DP) analytics, process validation, and comparability. Part 1 of this report summarized the discussions on drug-product analytics and comparability in BPI’s March 2021 issue (1). Here we report on day two presentations and discussions on validation, legacy products, and lifecycle management. Session Three: Drug-Product Validation The morning session focused on principles of process validation with examples of challenges specific to drug products. New Risk-Based…

April 16, 2021

Emerging Strategies for Drug Product Comparability and Process Validation: Part 1 — Analytical Tools and Drug Product Comparability

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Process validation is a key part of the development and manufacture of all approved drug products, but its completion can be a daunting task. At a two-day CASSS CMC Strategy Forum held in July 2016 in Gaithersburg, MD, speakers and attendees addressed the many technical, practical, and regulatory facets of drug product process validation and comparability. In part 1 of this report, we summarize the key discussion points of the first day, which focused on analytics and comparability. Session One:…

March 9, 2021

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

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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…

March 20, 2017

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

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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…

April 12, 2016