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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
Reimagining Affordable Biosimilars
Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is undergoing a transformation from multi-billion-dollar blockbusters to personalized medicines. More than 300 active biopharmaceut…
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
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
Maximum Output Starts with Optimized Upstream Processing
Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the development and manufa…
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
Virus-like Particles as Therapeutic Moieties of the Future
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like particles (VLPs) are viral capsid shells assembled without encapsulated nucleic acid. These particles resemble native virions, are …
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…
Article
N-Glycan Analysis of Biotherapeutic Proteins
By Aled Jones
Protein glycosylation, the addition of single sugars or oligosaccharide chains (glycans) to a peptide backbone, is a common post-translational modification (PTM) that imparts various…