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Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Please feel free to email your suggestions for terms that should be added, or definitions that you think could be refined to [email protected]   A B C D E F G H I J K L M N O …

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johnathan L. Coffman, Christopher Gallo, and Ranga Godavarti ABSTRACT In recent ye…

Article Single-Domain Antibodies for Brain Targeting
Smaller recombinant antibody fragments as single-domain antibodies (sdAbs) are emerging as credible alternatives because of their target specificity, high affinity, and cost-effective recombinant prod…

Article Continuous Manufacturing: A Changing Processing Paradigm
While only a few approved biologic products in the market—less than 10%, according to estimates by Eric Langer, managing partner, BioPlan Associates—are manufactured through perfusion or continuous do…

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
In this paper, the authors review the various analytical methods that can enable use of PAT. A critical evaluation of suitability of each analytical method as a PAT tool in terms of sampling (in-line,…

Article Modular Manufacturing Platforms for Biologics
While the idea of modular construction has been used in other industries for decades, it has only started gaining traction for pharmaceutical applications during the past 20–30 years. Modular syst…

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
Facility design and control considerations for commercial biopharmaceutical manufacturing processes include environmental controls (e.g., temperature, humidity, and pressure), air quality (e.g., parti…

Article Quality by design for biotechnology products—part 1
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta, Stefanie Pluschkell, Mark Rosolowsky, Anurag S. Rathore, PhD, Ma…

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
Junker. Beth H. Junker is the senior director of fermentation and development operations at Merck Research Laboratories ABSTRACT The aim of this paper is to describe a meth…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
By Luhong He, Christopher Frye Abstract The Chinese hamster ovary (CHO) cell lines used for the production of recombinant therapeutic proteins are immortalized cells with a relatively high degre…

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