Search results for " activity"
Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Process Development Forum speaks with Günter Jagschies, Cytiva, who is sitting on the organizing committee for the Recovery of Biological Products XVII Conference, which will take place June 19-24, …
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve
Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …
Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
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…