Search results for " bioanalytical" in Articles / App Notes
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Videos! SPR Applications in Protein Characterization
In these exclusive videos from the Biacore Analytical, Comparability and QC Symposium, Vienna, November 2017, industry thought-leaders share insights, tips, and techniques that illuminate how SPR with…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
For biosimilars, Schuman says, “There is much more dependence upon bioanalytical assays, as opposed to some other cell-based assays, because that proof has already been accomplished by the originator.…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
FDA, Guidance for Industry, Bioanalytical Method Validation (Rockville, MD, May 2001).
8. D.M. O’Hara et al., AAPS J. 14 (2), pp. 316-328 (2012).
9. R.F. Staack, et al.…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
Unlike the development of small molecules, several bioanalytical assays are necessary in the early development of biologics, which are typically produced within engineered cells from pharmacologically…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…