Search results for " degradation"
Article
Fusion Proteins Pose Manufacturability Challenges
Some fusion proteins are also prone to proteolytic degradation during production and/or after therapeutic administration, according to Carter. This issue can sometimes be overcome by modifying the jun…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
Article
Antibody Production in Microbial Hosts
coli has several cytoplasmic endogenous proteases that can cause proteolytic degradation; this represents a critical disadvantage of E. coli as a production vector. However, this problem has been succ…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Characterization of binding events is essential for confirmation of CQAs, plays a vital role in forced degradation studies, and can either complement or form the basis for potency assays. Binding assa…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
Moreover, the company failed to put in place intra-campaign controls aimed at verifying that during a production campaign the level of potential degradation residues in the equipment was maintained to…
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Optimization of Protein Expression in Escherichia Coli
Many problems are associated with protein expression, including toxicity, misfolding and degradation, aggregation in inclusion bodies, low yields, and difficulties in purification. One of the most com…
Article
Use of Multivariate Data Analysis in Bioprocessing
Similarly, application of surface-enhanced Raman scattering (SERS) spectroscopy for simple and fast analysis of cell-culture media degradation has been demonstrated (16). In this work, chemometric too…
Article
Quality by Design and Extractable and Leachable Testing
Depending upon the contents, packaging may also serve to shield the drug product from oxidation, light degradation, and moisture permeation. The packaging must clearly identify its contents and may in…
Article
Trends in Single-use Bioreactors
Recent studies have shown that this can be attributed to a degradation product of a commonly used antioxidant.
Establishing full traceability of raw materials, robust process controls, and meaning…