Search results for "biologic" 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
Materials based on synthesized polymers may have higher levels of extractable components, or may nonspecifically bind biological molecules via ionic or hydrophobic interactions. Regardless, the materi…
Article
DoE Provides Benefits, but Preparation Is Necessary
…rtant early in the development of a biopharmaceutical product given the limited availability of the biologic API. Further, a DoE approach can be particularly useful for combination products that have…
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
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (2012).
5. M. Schweitzer, et al., Pharm. Technol. Eur. 22 (2) 29-37 (2010).
6. V.R. …
Article
Single-Domain Antibodies for Brain Targeting
Going single domain
Biologic therapies such as monoclonal antibodies (mAbs) are enabling the targeted, personalized treatment of cancer, inflammatory diseases, infectious diseases, and diseases of…
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
…ector 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 Europ…
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
…cularly those governing data protection, patents, and trade secret protection--that are relevant to biological products.
Protecting IP, leveraging risk
The biotechnology industry is a dyna…
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…