Search results for " serum"
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Leveraging Computational Models of Glycosylation for Biopharma QA
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Impact of Media Components on CQAs of Monoclonal Antibodies
It is typically composed of a complex mixture of amino acids, vitamins, inorganic salts, glucose, and serum as a source of growth factors and hormones. The choice of cell culture media has been known …
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Fusion Proteins Pose Manufacturability Challenges
Making proteins ‘druggable’
Many proteins have short half-lives in human serum, making them unsuitable as recombinant protein drugs. When constructed as fusion proteins, however, they may become ‘…
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Application of Quality by Design to Viral Safety
These materials can be complex, such as animal serum, or purified products, such as porcine-derived trypsin or a recombinant-affinity chromatography ligand. While the quality of these biological raw m…
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Optimizing your Cell Culture Process to Improve Productivity
The testing can be applicable to a wide variety of sample types, that includes chemically refined media and supplements, media containing serum or other animal products, and media containing hydrolysa…
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Report from the 12th Plasma Product Biotechnology Forum
…ncing a new class of fully humanized, highly potent polyclonal antibodies without the need for human serum, as they are based on bovine plasma from transchromosomic cows. Despite the unusual raw mate…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Another driver pushing developers to consider suspension cell lines is the desire to move away from serum for biosafety, cost, supply, and processing needs. However, as it will be explained later, the…
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Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
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Improving Upstream Predictability
… of stable producer cell lines, which will result in increased productivity per cell, greater use of serum free or chemical defined media systems, and a better understanding and ability to measure me…
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Emerging Therapies Test Existing Bioanalytical Methods
qPCR is used to quantify a viral genome in serum, tissue, or body fluids for the purpose of pharmacokinetics (PK), biodistribution, or vector shedding evaluations (3,4,6). It is also used to measure t…