Search results for " biologics" in Articles / App Notes
Article
What Drove Biopharma Development in 2014?
As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that trend is only expected to rise. According…
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
DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist t…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
Can you identify geographical or company size differences in who is using QbD?
Since the early push for QbD implementation in biologics came from the U.S. FDA, major manufacturers based in North Am…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
Article
Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
An upside to this model is that many breakthrough biologics and innovative platforms are coming from small, start-up research companies, but their resources are limited. To get involved in development…
Article
Global Expansion Shapes Drug Oversight
…rector of the Center for Drug Evaluation and Research, and Karen Midthun, director of the Center for Biologics Evaluation and Research, unveiled a new initiative to collaborate more with EMA and Euro…
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.
There is a clear link between a country’s rate of economic development and the strength of its intellectual p…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Several white papers will be discussed covering both small molecules and biologics. Professor Charles Cooney and I will be presenting the white paper on continuous bioprocessing.
The transit…