Author Archives: Patricia Seymour

The Therapeutic Monoclonal Antibody Product Market

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Commercial development of therapeutic monoclonal antibodies (MAbs) began in the early 1980s, and by 1986 the first MAb product had been approved in the United States: muromonab-CD3 (trade name Orthoclone OKT3, marketed by Janssen-Cilag) for prevention of kidney-transplant rejection. Since its approval, therapeutic MAbs and antibody-related products such as Fc-fusion proteins, antibody fragments, and antibody–drug conjugates (collectively referred to herein as “MAb productsâ€) have grown to become the dominant product class within the biopharmaceutical market. They have been approved for…

October 30, 2020

Supply and Demand Trends: Mammalian Biomanufacturing Industry Overview

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Since the 1986 approval of the first recombinant therapeutic antibody, OKT3, biopharmaceuticals have become a large percentage of overall pharmaceutical company revenue. In 2018, sales of the top five selling recombinant proteins — Humira (adalimumab, AbbVie), Keytruda (pembrolizumab, Merck), Herceptin (trastuzumab, Genentech), Enbrel (etanercept, Amgen), and Avastin (bevacizumab, Genentech), all antibodies — totaled over US$48 billion. The compound annual growth rate (CAGR) for antibodies revenue was about 20% from 2004 to 2014. Those products include naked monoclonal antibodies (MAbs), Fc-fusion…

February 7, 2020

Outsourcing and Biomanufacturing Challenges for Emerging Therapies: A Roundtable Discussion at BIO 2016’s BPI Theater

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The biopharmaceutical industry is increasingly interested in a range of emerging therapies. “We’re really starting to get beyond the monoclonal antibody,†said Patricia Seymour (senior consultant with BioProcess Technology Consultants) in her introduction to a lunchtime BPI Theater roundtable at the 2016 Biotechnology Industry Organization annual convention in San Francisco, CA, this past June. The discussion brought together three industry insiders for strategic outsourcing to talk about emerging biotherapies and their manufacturing challenges: Mark Angelino (senior vice president of pharmaceutical…

September 15, 2016

Emerging Biotherapies and Their Manufacturing Challenges

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A BPI Theater Roundtable at the 2016 BIO Convention On Tuesday, 7 June 2016, Patricia Seymour (senior consultant in process development at Bio Process Technology Consultants) chaired a lunchtime roundtable titled, “Emerging Bio-Therapies and Their Manufacturing Challenges.†She brought together a panel of three industry experts: Mark Angelino (senior vice president of pharmaceutical sciences at BlueBird Biotechnology) Andreas Weiler (global business unit head of emerging technologies at Lonza) Chris Chen (chief executive officer of WuXi Biologics). Mark Angelino (BlueBird Biotechnology)…

August 11, 2016

BioProcess Theater: Roundtable

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Stretching for the Trifecta Innovative Strategies for Speeding Development, Lowering Costs, and Enhancing Quality On Tuesday 16 June 2015, at noon on the BioProcess Theater stage at BIO 2015, Tom Ransohoff (vice president and principal consultant at BioProcess Technology Consultants, Inc.) will moderate a roundtable discussion with the following panelists: Mark Brower (senior research chemical engineer, Merck & Co.) Parrish Galliher (Xcellerex founder and chief technology officer, GE Healthcare) Joanne Beck (senior vice president of process development, Shire) Lynne Frick…

May 12, 2015

Technology Transfer of CMC Activities for MAb Manufacturing

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    With combined 2009 revenues estimated to be over US$40 billion, monoclonal antibody (MAb) products have become the dominant component of the biopharmaceutical market (1). Continued interest and development of this exciting class of products will drive the overall sales of biopharmaceutical products in the future, making them the fastest growing segment of the overall pharmaceutical market (2). To help companies developing MAb products, BioProcess Technology Consultants recently published a comprehensive report outlining the complex technical, regulatory, and strategic…

June 1, 2010