Search results for " biologic" in Articles / App Notes
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…
Article
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 …
Article
USP Publishes Monoclonal Antibody Guidelines
Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expa…
Article
FDA Approves First Biosimilar
To date, there are a total of five 351(k) applications that are publicly disclosed, including the one for Zarxio, said Leah Christl, associate director for therapeutic biologics and biosimilars in the…
Article
Quality by design for biotechnology products—part 1
Although biologic and biotechnology products often present a higher level of complexity than small molecules in terms of manufacturing process or product structure, the concepts of QbD are the same as…
Article
Sterilization Trends for Single-Use Consumables
Staying abreast of and managing trends in sterilization of SU consumables is therefore essential for biologics producers.
Several sterilization process essentials
Contamination poses a huge risk t…