Search results for " recombinant protein"
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
CHO cells are the predominant production hosts for recombinant protein production due to their adaptability to various culture conditions and plasticity with reference to genetic alterations (2–5). In…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Over the past several decades, numerous recombinant proteins have been approved as therapeutic drugs by regulatory authorities, and many more are currently undergoing clinical development (1). Chinese…
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Elucidating Biosimilars Characterization
NIBRT: Differences regarding the approval process for small molecules as compared to recombinant protein therapeutics are reflected in the complexity that must be considered when comparing small-molec…
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A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…
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Generating a Fully Processed Antibody
Protein conversion by FGE
Figure 1: Formylglycine-generating enzyme (FGE) protein recognition site and conversion process in the context of a recombinant protein of interest.
Formylglycine-gene…
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Best Practices for Selecting a Top-Quality Cell Line
… organization of chromatin in all mammalian cells and allow for higher and more stable expression of recombinant proteins.
A panel of tens to hundreds of high-expressing clones are assessed fo…
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Fermentation for the Future
coli, is the formation of insoluble aggregates of the overexpressed recombinant protein, referred to as IBs. In most cases, the IBs consist largely of the protein of interest, but may also include oth…
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Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Application of imaging capillary IEF for characterization and quantitative analysis of recombinant protein charge heterogeneity. Electrophoresis. 2008;29:4368–76.
23. Vasilyeva E, Woodard J, Taylo…