Search results for " biologics" in Articles / App Notes
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…
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
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 …
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
In summary, identifying the CQAs and setting appropriate specifications and acceptable limits (or validating removal if applicable) are the foundational activities of implementing QbD for biologics. T…
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…