Search results for " antibody" in Articles / App Notes
Article
Biosimilars: Making the Switch Comes with Challenges
Biosimilar infliximab, the first biosimilar monoclonal antibody (mAb) to be approved by EMA in 2013, has had an uptake varying from approximately 10-50% in the five leading EU markets of France, Germa…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Bioprocessing equipment and materials, as well as technical discussions about process development, were in prominent positions at the INTERPHEX 2016 trade show, held in New York in late April. Rita …
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
It was also used for simultaneous determination of media components such as folic, mycophenolic, nicotinic acids, hypoxanthine, and other components in protein-containing matrices from a monoclonal an…
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
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …
Article
Best Practices in Qualification of Single-Use Systems
Figure 1 depicts a typical monoclonal antibody (mAb) drug manufacturing process. Single-use bioreactors are widely used in cell line expansion, and the use at production scale is increasing, notably i…
Article
Aseptic Processing: Keeping it Safe
Many newer facilities, such as SAFC’s new antibody-drug conjugate-focused floor in its St. Louis, MO campus, have spaces that are designed to handle media fill for various types of products and have i…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
Provided FDA begins approving antibody-based biosimilars, she expects to see an increase in litigation for these medications in 2018 or 2019.
Sources:
Nature
GEN
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…