Search results for " biologic"
Article
Tackling Analytical Method Development for ADCs
Their composition--a biologic linked to a small-molecule cytotoxic, which enables targeted delivery--also creates challenges for analytical method development, both for characterization and lot releas…
Article
Labeling of Biosimilars
They claim that it does not highlight sufficiently the inherent differences between biosimilars and their reference products because being biological, they cannot be identical as small-molecule generi…
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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…
Article
Technology Innovations Improve Process Chromatography Performance
By Feliza Mirasol
Selecting an appropriate separation technology for biologic manufacturing is a crucial task in maximizing productivity in downstream bioprocessing. Biomanufacturers consider se…
Article
Best Practices for Selecting a Top-Quality Cell Line
Challener
Cell lines determine the performance of bioprocesses and the quality of the biologic drug substances they produce. As such, selection of the optimum cell line for each specifi…
Article
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…
Article
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…
Article
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
ELISA and SPR are commonly used for in-vitro confirmation of biological activity by measuring interactions with antigens, receptor, Fc-receptors, or other binding proteins (11, 13). Cell- or animal-ba…
Article
Selecting a Comprehensive Bioburden Reduction Plan
BioPharm: What procedure is used to identify the various points in which bioburden can be introduced? Is the identification process performed for each variety of biologic product?
Hutchinson: The …