Search results for " activity"
Article
Applying GMPs in Stages of Development
Without a robust and transparent exchange of information, the technology-transfer activity has the potential to be frustrating and delayed while people try to find a common understanding and locate ne…
Article
ADC Development Robust Despite Lackluster Performance
This ADC is expected to go into a Phase II trial in metastatic urothelial cancer in the second half of 2017 and has been undergoing a Phase I trial evaluating its safety and antitumor activity in esca…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
These products are subject to post-translational modifications such as glycosylation, phosphorylation, methylation, hydroxylation, and sulfation that affect their activity and immunogenicity. Conditio…
Article
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
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
Optimization of Protein Expression in Escherichia Coli
It should be noted that tagging of a target protein may interfere with its correct folding, assembly of complexes, the activity of protein, and even expression yields, so it is best to leave a protein…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
… the relatively high pH of the in-vivo environment or in inflammatory environments and cause loss of activity as well as elicitation of immune responses.” Thus, FDA suggests therapeutic protein produ…
Article
Labeling of Biosimilars
Instead, a biosimilar has to demonstrate similarity to the reference product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exerc…