Search results for " information"
Article
Being Thorough When Transferring Technology
According to Mike Ultee, principal of Ulteemit BioConsulting, companies often fail to provide complete information about their biopharmaceutical or protein. He suggests that companies should allow eno…
Article
Quality by design for biotechnology products—part 1
Based on this information, the sponsor then designs the molecule, the manufacturing process, and the control strategy to ensure that the desired product quality is met consistently.
The QbD approa…
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What's in Your SOP?
My colleagues have very different ideas on how much information should be included in the SOPs. Some want very detailed instructions and others want minimal information. Can you please advise on how d…
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N-Glycan Analysis of Biotherapeutic Proteins
N-glycosylation
The flow of biological information in the DNA-RNA-protein central dogma of molecular biology (6) is complemented by a repertoire of PTMs including phosphorylation, lipidation, N-ac…
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Analysis of Glycosylation in Biosimilars
If this information is combined with amino acid analysis to quantitate the amount of protein in the sample, the levels of different monosaccharides per unit protein can be determined. This is a simple…
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Implications of Cell Culture Conditions on Protein Glycosylation
The analysis gives some structural information in terms of an idea of what has been produced but little information in terms of the precise nature of what the glycans are. Techniques like this are, th…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
While many analysis instruments can measure particle size distribution, to identify the nature of particulates in protein therapeutics, information about particle shape and morphology is necessary, sa…
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Predicting Progress in Protein Aggregation
Thus, efforts have been invested in synthesizing analogs and studying their behavior to expand the database of information on known proteins and antibodies. Lonza’s database currently includes informa…
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Setting Up Bioprocessing Systems for Digital Transformation
The challenge here is that the Industrial Internet of Things (IIoT) has added more information from an ever-wider array of sources. “Plants need strategies and technology to maintain ‘chain-of-identit…
Article
The Importance of Partnering for Bioanalytical Studies
…ailability (BA)/bioequivalence (BE) evaluation, and some nonclinical studies requiring concentration information for pharmacokinetics, toxicokinetics, or biomarkers. Bioanalytical work serves to supp…