Search results for " FDA" in Articles / App Notes
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A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Also, during this period, the number of FDA-approved recombinant therapeutics has increased by approximately 400% (6,7). In 2017, FDA set a record for the number (31 approvals) and percent (93%) of ap…
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Leveraging Data for Better Biopharmaceutical Process Control
IFPAC 2018 already showed this year several talks on MS-based multiple attribute methods (MAM), a new acronym being used by FDA’s Emerging Technology Team (ETT) to name the PAT use of these methods.
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Bioburden Entry Points in Downstream Processing
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips in this blog.
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Roadmap Leads to Innovative Biomanufacturing Strategies
In fact, a ‘regulatory’ sub-team has already been formed, and some informal communication with FDA has begun.
The intention is to keep the agencies informed of the Biomanufacturing Technology Ro…
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
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Witnessing Major Growth in Next-Generation Antibodies
In January 2017, FDA granted orphan drug status to the company’s candidate MGD006 (also known as S80880), a DART molecule for the investigational treatment of acute myeloid leukemia.
The company i…
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Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
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Ensuring the Biological Integrity of Raw Materials
(2,3)
Global regulations, including those from the United States Department of Agriculture, the European Medicines Agency, and the FDA’s Center for Biologics Evaluation and Research (CBER) set sta…
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Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…