Search results for " industry"
Article
Implications of Cell Culture Conditions on Protein Glycosylation
FDA, Guidance for Industry, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, Apr. 2015).
4. FDA, Guidance for Industry, Quality Considerations in Demo…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Participants from academia and industry meet and discuss the latest developments in an environment away from the daily routines, rich in scientific quality and engagement, and free from commercial dis…
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
Fluid Handling in Biopharma Facilities
Automating this process into a closed system and out of a laminar flow hood would be of tremendous benefit to the industry.
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
What is your view of HIC in the biotech industry today and its role in the future?
HIC is a powerful purification technique that is well established and will remain important in the future. It pro…
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Breakthrough Drugs Raise Development and Production Challenges
And they indicated that additional resources from industry are warranted to support the unexpectedly large breakthrough program.
While FDA can quickly approve products with clear outstanding value…
Article
Host-Cell Protein Measurement and Control
Measuring and Monitoring Residual HCPs
To date, immunoassay, commonly in the form of sandwich enzyme-linked immunosorbent assay (ELISA) (see Figure 1), remains as the industry gold standard for HC…
Article
Continuous Chromatography: Trends, Definitions and Approaches
Read More Q&As With Industry Leaders Here
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
FDA, Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (Rockville, MD, August 2014).
Article Details
BioPharm International
Vol. 28, No. 3
Pages: 22-26 …