Search results for " pharmaceutical" in Articles / App Notes
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Special cell-culture considerations for biosimilars
Biosimilars are “generic” versions of protein pharmaceuticals that must be highly similar to the innovator drug in order to be classified as such…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
To date, the majority of monoclonal antibodies (mAbs) have generally targeted a particular antigen; however, there are several additional antibody formats currently in the development pipelines of pha…
Article
Antibody Fragments and Their Purification by Protein L Affinity Chromatography
Antibodies and related proteins comprise one of the largest and fastest-growing classes of protein pharmaceuticals. A majority of such molecules are monoclonal antibodies; however, many new entities…
Article
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
Article
Selecting a Comprehensive Bioburden Reduction Plan
69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations, published June 2015.
Targeting Bioburden
BioPharm: What type of planning is necessary to target all asp…
Article
Optimization of Protein Expression in Escherichia Coli
May 01, 2015
By Siavash Bashiri, David Vikström, Nurzian Ismail
BioPharm International
Volume 28, Issue 5
Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…
Article
Re-use of Protein A Resin: Fouling and Economics
30-40; Pharmaceutical Technology Europe, March (2003), pp. 45-56.
21. J. Moscariello, E. Lightfoot, and A. S. Rathore, BioPharm International 18 (8) (2005).
22. A. S. Rathore, S. Mittal, S. Lu…
Article
SEC in the Modern Downstream Purification Process
The simplicity of the separation mechanism and the power to separate large molecules or complexes from those smaller products or impurities not intended as an active pharmaceutical ingredient ensures …
Article
FDA Approves First Biosimilar
The approval is a groundbreaking decision, as Sandoz is the first pharmaceutical company to have a biosimilar product approved in the United States. Known as Zarzio outside of the US, Sandoz says its …