Search results for " biologics"
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Bioprocessing is no exception, as the industry continuously seeks to improve large-scale commercial production of traditional biologics, in addition to seeking innovative ways to meet the bioprocessin…
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Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
Article
Best Practices for Selecting a Top-Quality Cell Line
…tion cell line attributes,” agrees Jill Cai, vice-president of cell and protein sciences with WuXi Biologics.
Before scaling up to bioreactors, the productivity level for monoclonal antibodies…
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Using Multiple Techniques in Biosimilar Analysis
Whether they are called ‘sameness’ for generic drugs, ‘comparability’ for biologics, or ‘analytical similarity’ for biosimilars, these tests are crucial for any regulatory submission, which is vital t…
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The Challenge of Disruptive Technologies in Bioprocessing
Jul 01, 2018
Increasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
By Feliza Mirasol [1]By Feliza Mirasol [1]
Increasing demand for biologics is dri…
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Perfusion in the 21st Century
Perfusion is also used for biologics that are toxic to the producing cell line and cannot be produced under fed-batch conditions (4).
Within the past decade, however, changes in the biopharmaceuti…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Personnel Training
BioPharm: Does operating personnel need specific training on bioburden reduction?
Souza: The manufacture of biologics requires operators trained in aseptic techniques, with …