Search results for " FDA"
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
In addition to assessing factors and conditions for the optimization of the purification steps, the quality-by-design (QbD) initiative introduced by FDA requires a deeper understanding of critical pro…
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Cleaning of Dedicated Equipment: Why Validation is Needed
During an inspection conducted by FDA, it was observed that tanks used for the manufacture of a single API, carried out a few months before, were not cleaned since the last campaign. The interior of t…
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Taking a “Development-by-Design” Approach to Cell Therapies
…one a step further, and broadened the International Conference on Harmonization guidances adopted by FDA into “development by design” (DbD).
“We say, first consider the endpoint, then take proces…
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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…
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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…
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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…
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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…
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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…
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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…