Search results for " assays" in Articles / App Notes
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
In comparison, biopharmaceutical innovators sought improved analytical assays and development, control systems, fill-finish services, and downstream PD services.
Why are CMOs early adopters?
…
Article
Vaccine Development Faces Urgency and Challenges
FDA would get $10 million to support oversight of vaccines and diagnostics, as well as assays to screen blood for the Zika virus. Additional resources would help the US Department of Health and Human …
Article
Tools for Continuous Bioprocessing Development
…the high-throughput platform
• Provide backward compatibility to all existing in-line and final assays/instruments performed by process development teams.
State of the art for scale-down
Ap…
Article
Biacore Concentration and Ligand-Binding Analyses
In this white
paper, the use of Biacore for active concentration measurements, target binding, and Fc receptor (FcR) analysis is reviewed along with the use of these assays for assessment of drug po…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Extensive analytical assays are needed to characterize a protein therapeutic. Biosimilars require even more analytical testing than do innovator drugs because of the need to prove biosimilarity to the…
Article
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA pro…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …