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Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Some of the major strategies and tools to address these challenges include the development of highly efficient platforms, high-throughput screening (HTS) tools, and reduction of the number of unit ope…

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
Furthermore, developing this class of drugs is expensive and time consuming. Costs range from approximately $500 million to $3 billion, and development takes more than a decade, the majority of which …

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
…and where all of the cleanroom components live (inside the actual unit that is shipped or inside the existing facility infrastructure). There are modular room enclosure systems (such as from Daldrop,…

Article Maximum Output Starts with Optimized Upstream Processing
…s, viral oncolytics, and cell, gene, and gene-editing therapies—was occurring worldwide before the emergence of the COVID-19 pandemic. Demand for biosimilars is also increasing. The requirements asso…

Article Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…

Article Virus-like Particles as Therapeutic Moieties of the Future
Rathore Virus-like particles (VLPs) are viral capsid shells assembled without encapsulated nucleic acid. These particles resemble native virions, are highly ordered and repetitive, and are approxi…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Given this inherent genetic flux, recombinant genes (or transgenes, also referred to as the expression construct) expressed in CHO cells—used for therapeutic bioproduct development—can be subject to g…

Article N-Glycan Analysis of Biotherapeutic Proteins
More than half of all biotherapeutics are glycosylated (2), including monoclonal antibodies (mAbs), Fc-fusion proteins, clotting factors, and cytokines such as erythropoietin. Of these, mAbs represent…

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