Business

eBook: Vaccines — COVID-19 Invigorates a Stagnant Industry

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The SARS-CoV-2 novel coronavirus has galvanized what was a stagnant and oligopoly-run vaccine industry. In this inaugural BioProcess Insider eBook, the first of four to be published in 2021, founding editor Dan Stanton explores economic and technical conditions that until now have hampered innovation in vaccine development and discouraged market entry for emerging biotechnology companies. Leveraging commentary from vaccine industry experts and analyzing the range of emerging vaccine modalities, Stanton surveys how industry responses to the COVID-19 pandemic are fostering…

February 18, 2021

The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

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The biopharmaceutical industry continues to develop advanced manufacturing processes, systems, technologies, and facilities. Regulations play a significant role in assessing and approving marketing authorizations for drug products that are submitted for approval. The industry and regulators together should form a coordinated, streamlined process that delivers much-needed medicines around the world. Global Complications The complex global nature of biopharmaceuticals sometimes means that progress is not always as smooth as it could be. One main reason is that regulatory agencies often differ…

February 4, 2021

Top Trends in Biomanufacturing

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Facing an ongoing pandemic, growing pipelines, and a possible capacity crunch, the bioprocess industry is striving to balance its priorities. Those are some of the key issues to watch according to the 17th annual report and survey of biopharmaceutical manufacturing capacity and production from BioPlan Associates. It includes survey responses from 130 decision-makers (from 33 countries) at both bioprocessing organizations and contract manufacturing organizations (CMOs) and responses from 150 bioprocess industry suppliers (1). Top trends from this report are highlighted…

February 4, 2021

Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures

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The motto of the European Serum Products Association (ESPA) — “Serum Saves Lives” — reaffirms the essential role that animal serum plays in cell-culture–based research and applications to protect the health of both human and animal populations. Animal serum, especially fetal bovine serum (FBS), needs to be available in abundant supply and at affordable prices to medical and veterinary facilities all over the world. With one billion cattle globally, the supply of FBS should be plentiful, but not all countries…

February 4, 2021

Don’t Be Forced to Accept a Bad Deal During the COVID-19 Crisis

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Your boss’s boss just gave you the mandate to procure equipment, components, and raw materials for development and production of a new vaccine. Your goal is to get those as soon as possible — in addition to securing a massive volume for the future. You and your company are in the spotlight, and under significant pressure to deliver. You simply cannot fail. Yet many other players in your industry find themselves in the very same situation. Demand is exploding, and…

December 17, 2020

Accelerated Pathways for Authorization of Medicines in Europe and the United States

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Before a medicinal product can be considered suitable for patients, it must go through laborious testing and cost-effectiveness analysis. In addition, all medicinal products must be authorized before they can be sold on the market and thus made available to patients (1). This is the case in the European Union (EU) and European Economic Area (EEA) countries as well as in the United States (US). Every year, a number of medicines receive marketing authorization. In their wake, however, several thousand…

December 17, 2020

Manufacturability Assessment: A Tool for Effective and Transparent Decision-Making and Efficient Process Development

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Design for manufacturing (DfM, also known as design for manufacturability) is a common approach in engineering industries when complex, multistep production processes are developed and installed to manufacture products. Adherence to DfM approaches has been prevalent for decades in the automotive, aerospace, and electronics industries, among others (1–3). Recently, a generalized manufacturability-assessment tool with strategies to weigh different aspects of manufacturing has been proposed with numerous similarities to that described herein specific to the field of bioprocess development (4). Although…

December 17, 2020

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 products”) have grown to become the dominant product class within the biopharmaceutical market. They have been approved for…

October 30, 2020

The Crossroads of Academia, ​Industry, and Education: Modern Training Centers Are Pivotal to the Future of R&D

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Global pharmaceutical industry research and development (R&D) investment has experienced steady growth over the past two decades, with an anticipated compound annual growth rate (CAGR) of 3.0% and projected 2024 investment of US$213 billion (1). Focused on developing innovative therapies for chronic, infectious, genetic, and lifestyle-related ailments, the fast-growing biologics segment has become a cornerstone of the pharmaceutical industry and healthcare sector. The demonstrated effectiveness and wide-ranging applicability of biopharmaceuticals also have brought considerable R&D in computational and biological technologies.…

October 29, 2020

Finding Efficiencies to Accelerate Biopharmaceutical Development

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An old engineering adage says that in any technical project, you can get speed and/or quality and/or cost-efficiency — but you never get to have all three. The idea is that emphasizing any one of those parameters necessarily deemphasizes one or both of the others. For most of the biopharmaceutical industry’s early years, companies operated on that assumption. Many organizations saw speed as the weakest link that could be more or less ignored; others had money to burn. The smartest…

June 16, 2020