Search results for " activity" in Articles / App Notes
Article
Host-Cell Protein Measurement and Control
Certain HCPs with proteolytic activity can also affect drug product stability and efficacy if not adequately removed or inactivated (4). HCPs have the potential to affect both the safety and efficacy …
Article
A Bright Future for the Plasma Fractionation Industry
There is still a very bright future for the plasma fractionation industry. That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful isla…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
The collaboration of highly motivated and highly skilled people across multiple programs of activity is the key to success in both areas,” Bird states.
As one example of how Fujifilm is using tech…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Trends in Single-use Bioreactors
Both setups allow for cell-free media extraction and permit continued cellular activity inside the vessel.
Galliher (Cytiva): Yes. Because single-use bioreactors are much simpler than stainless …
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
Article
High-Throughput Process Development in an Historical Environment
Presentations, discussions, and information-sharing on modern bioprocess technology and high-throughput process development (HTPD) in an historical and culturally enriched environment is the essence…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
Is QbD activity company-wide or occurring within smaller groups in the company?
QbD implementation started off as something that smaller groups would get involved with. However, as these concepts h…