Analysis and Characterization: The CMC Strategy Forum Series, Part 3 — Introduction

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The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They 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 the forum meetings are published in BioProcess International and on the CASSS website (www.casss.org). This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment will continue to be safe and efficacious.

This special report series highlights five general subject areas that have been covered in the first 10 years of the CMC Strategy Forum series: quality by design (QbD) and risk management; manufacturing strategies; analysis and characterization; assays, biosimilars, and comparability; and process- and product-related impurities. Appearing quarterly throughout 2015 and into 2016, these topics will be represented by reprinted reports from one or more forum meetings along with additional information.

Please note that older documents may be superseded by more recent regulatory guidelines, but we believe that the view of how some of those concepts and practices have evolved is valuable in and of itself. Readers should keep in mind that some listed links may be nonfunctional, especially for older references; a search engine is always helpful in such cases. Also, in the interest of accuracy, the authors are listed with their affiliations at the time the papers were originally printed.

Looking Ahead

The importance of analytical methods has become more apparent with the advent of QbD. They are essential to development and validation of manufacturing processes for biological drug substances and final drug products, as well as quality assurance and control (QA/QC), raw materials monitoring, and environmental monitoring. This special report focuses on drug-substance characterization (structural analysis, glycosylation) and lot release of monoclonal antibody (MAb), antibody–drug conjugate (ADC), and viral drug products.

In November, we’ll follow up on those topics with a closer look at test methods and comparability: method qualification, demonstrating comparability, bio- and binding assays for lot-release and stability testing, the relationship between higher-order structure and quality, and biosimilar issues. The latter will be our main focus.

And then in early 2016, we plan to wrap up this series with a report on process and product-related impurities. This will include discussion of extractables and leachables, product profiles, mycoplasma testing, and aggregates and particles.

Our thanks go out to Karen Bertani of CASSS (www.casss.org), an international separation science society, as well as the steering committee (left) of this forum series, for trusting BPI as the publishing partner in this endeavor.

Cheryl Scott is cofounder and senior technical editor of BioProcess International, [email protected].

CMC Strategy Forum Advisory Committee

Siddharth J. Advant (ImClone); John Dougherty (Eli Lilly and Company); Christopher Joneckis (CBER, FDA); Rohin Mhatre (Biogen Idec Inc.); Anthony Mire-Sluis (Amgen, Inc.); Wassim Nashabeh (Genentech, a Member of the Roche Group); Anthony Ridgway (Health Canada); Nadine Ritter (Global Biotech Experts); Mark Schenerman (MedImmune); and Keith Webber (CDER, FDA)