Search results for "antibodies" in Articles / App Notes
Article
Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
One sign of progress was the opening of a JHL Biotech flexible manufacturing facility in Wuhan, China on May 10, 2016, for the manufacture of biosimilars and monoclonal antibodies (mAbs). The facility…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
Article
Biacore Concentration and Ligand-Binding Analyses
Biotherapeutic drugs including antibodies, cytokines, and hormones are used for treatment of a variety of diseases including arthritis, cancer, and diabetes. Compared to traditional small-molecule dru…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Notably, the latter changes, which will take effect in early 2016, include expectations for authentication of key biological and/or chemical resources, such as cell lines, antibodies, and other biolog…
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Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
Article
Ensuring the Quality of Biologicals
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …
Article
Modular Manufacturing Platforms for Biologics
By using modularization and the other aforementioned technologies such as continuous manufacturing, facilities to produce monoclonal antibodies (mAbs) can also be operational 12 months after project i…