Search results for " FDA" in Articles / App Notes
Article
A Bright Future for the Plasma Fractionation Industry
In March 2014, Biogen received its recombinant Factor IX-Fc fusion protein (Alprolix™) approved by FDA, and in December, CSL Behring also submitted a biologics license application (BLA) for the market…
Article
USP Publishes Monoclonal Antibody Guidelines
Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expa…
Article
Technologies and Practices Must Evolve to Meet Demand
3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule drugs grows, bioprocessing capabilities must kee…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implementi…
Article
Application of Quality by Design to Viral Safety
…a and publicly available information, such as a database of reported viral clearance compiled by the FDA (11). A parameter should be included as part of a design space if performance (viral clearance…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Kozlowski, “Implementation Activities for QbD: FDA Office of Biotechnology Products,” presentation at 2010 WCBP CMC Strategy Forum (Bethesda, MD, 2010).
11. L. Zang, X. L. Hronowski, Y. Lyubarskay…
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Biopharma Moves to Integrated, Single-Use, Downstream Processing
On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have histori…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
The company received FDA approval for Flucelvax, the first cell-culture vaccine in the US designed to protect against seasonal influenza in individuals 18 years of age and older, in November 2012 and …