Search results for " therapeutic" in Articles / App Notes
Article
Cell-free Expression Systems Pose Cell Culture Alternative
The professors explain that protein therapeutics (biologics) produced by cell culture face limitations, such as high product variability created by glycoform (micro- and macro-) heterogeneity; difficu…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Unlike other biological drug products such as therapeutic proteins, monoclonal antibodies, or vaccines, drugs based on living cells are by nature uniquely vulnerable to supply chain complications and …
Article
Science Focus Fuels Successful Process Development for Startups
BriaCell Therapeutics (BriaCell) is an immuno-oncology company that develops novel targeted immunotherapies for multiple cancer indications. These immunotherapies include Bria-IMT and Bria-OTS, which …
Article
Platform Technologies Improve Protein Expression
In addition, new technologies for genomic engineering of cells for the production of therapeutic proteins are “opening up a new world of possibilities to tailor-make protein-based drugs with appropria…
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Continuous Manufacturing: A Changing Processing Paradigm
The platform flows a liquid culture medium from a perfusion bioreactor into a preliminary multi-column chromatography system (MCCS1), then the eluate of the MCCS1 containing the recombinant therapeuti…
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Regulatory Challenges in the QbD Paradigm
This model is especially evident in FDA's Center for Drug Evaluation and Research (CDER) as used for therapeutic biological products, such as proteins and monoclonal antibodies. These products were tr…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
In the future, mAbs may represent a smaller percentage of the pipeline as portfolios concentrate more on development of antibody fragments, nanobodies, biosimilar protein therapeutics, conjugated prot…
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Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
Leronlimab is a novel CCR5 antagonist with the potential for multiple therapeutic indications. It has been and is currently being administered to COVID-19 patients at New York City area hospitals as p…
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Preclinical Evaluation of Product Related Impurities and Variants
Two case studies—one involving a microbial therapeutic product (granulocyte colony stimulating factor)—and other—a mammalian therapeutic monoclonal antibody (bevacizumab) have been used to illustrate …
Article
N-Glycan Analysis of Biotherapeutic Proteins
Figure 1A represents some of the therapeutic effects of biantennary N-glycans of the Fc region of IgGs. Interaction of the Fc region of IgG with Fc-γ receptors (FcγR) influences immune effector functi…