Search results for "EX"
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of B…
Article
Single-Domain Antibodies for Brain Targeting
IgG, the main serum antibody, the intact form of which is almost exclusively used in therapeutic antibodies, is a Y-shaped, multidomain protein with antigen-binding sites located on the two Fab (antig…
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Reimagining Affordable Biosimilars
…uted to their unique target specificity in protein–protein interactions for the treatment of complex diseases such as cancer, hematological disorders, and autoimmune diseases (1).
The developmen…
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Continuous Manufacturing: A Changing Processing Paradigm
Presenters of a BioPharm International webinar, “The Future of Continuous Downstream Bioprocessing,” cite continuous biomanufacturing initiatives at an Amgen Singapore plant as an example of how manuf…
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Modular Manufacturing Platforms for Biologics
…nd 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, …
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Maximum Output Starts with Optimized Upstream Processing
“The situation is evolving as the industry continues to explore the right balance between internal capacity/capability and external capacity/capability and key strategic partnerships,” says Lynn Botto…
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Quality by design for biotechnology products—part 1
Applying those concepts to the manufacture of biotech products, however, involves some nuances and complexities. Therefore, this paper offers guidance and interpretation for implementing QbD for bioph…
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Virus-like Particles as Therapeutic Moieties of the Future
The uniformity and self-assembly of VLPs, along with their ability to withstand chemical modifications primarily on the outer surface, make them flexible and stable alternatives to nanoparticles, such…
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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…
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N-Glycan Analysis of Biotherapeutic Proteins
The complex, branched structure of N-glycans present a unique analytical challenge. A variety of approaches exist, each with their own advantages and limitations. In this article, the biological effec…