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
FDA, major manufacturers based in North America are the furthest along in QbD implementation followed by the major manufacturers based in Europe. These are followed by the mid-size companies based in …
Article
Application of Quality by Design to Viral Safety
… 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
FDA) about how to go about implementing QbD. The present phase (2012-ongoing) is more about refinement of QbD. Most major and mid-size biotech companies know what QbD means and how to go about impleme…
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…
Article
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
FDA has long been viewed as the gold standard for a science-based regulatory system. However, the report says, the number and complexity of regulatory requirements has increased, and executives are co…
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 …