Search results for " degradation"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
The chosen separation and detection technologies must also be suitable to the analysis without degradation of the impurities occurring.
Overall, potential process-related and other residual impu…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
Article
Unifying Continuous Biomanufacturing Operations
Product quality improvements
The known benefits of continuous manufacturing include: reduction in the degradation effects of proteases (9), a smaller footprint, higher cell concentration/higher pr…
Article
Critical Quality Attributes Challenge Biologics Development
Protein modifications (such as post-translational modifications) and degradation products may affect potency as well as secondary pathways such as altered clearance or induction of immunogenicity.
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Article
Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Elimination of process collection and hold steps is a major benefit of continuous processing, concurs Snow, as product degradation and aggregation typically happen in these phases. Langer notes that p…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
…or unfolded proteins (Sil1), ubiquitin-like domain protein for endoplasmic reticulum (ER)-associated degradation (Herpud1), and three unknown genes. Instead of downregulation, these genes were either…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Formulation of the lipid nanoparticles required to protection of mRNA vaccines from degradation can be challenging, however; the correct ratio of lipids, proteins and nucleic acids is needed to form t…
Article
Reimagining Affordable Biosimilars
These methodologies elucidate 3-D conformation dynamics of proteins, thus enabling hotspot predictions for post-translation modifications (PTMs), sites, and extent of degradation (20).
Spectros…