Search results for "FDA"
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ADC Development Robust Despite Lackluster Performance
The road to market has been difficult, however, with only three ADC products approved for sale by FDA in the United States as of October 2017. This has not stopped ADC developers, though, and the biop…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
FDA’s focus on the need for updates is creating both opportunities and challenges for biologics manufacturers involved in the scale-up and transfer of production technologies. Single-use and modular t…
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The Lifecycle Change of Process Validation and Analytical Testing
… CEO, and Luke Kiernan, technical services director, of Innopharma Labs in Dublin, about the impact FDA's 2011 process validation guidance has had on analytical testing and validation.
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Sterilization Trends for Single-Use Consumables
The driver behind this trend stems back to a Form 483 issued by FDA (4) indicating that the pharmaceutical manufacturer may not have understood or challenged the statement on a supplier certificate st…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Biosimilars and the impact of FDA guidance
BioPharm: Regarding biosimilars, there have been some changes in the US, with FDA setting requirements for analytics and for interchangeability…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Yu, deputy director of the Office of Pharmaceutical Quality in FDA’s Center for Drug Evaluation and Research, talked about the future of pharmaceutical quality—and the challenges of achieving quality …
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Microbiological Testing: Time is of the Essence
In addition, FDA has made changes to its microbial testing requirements that have had a positive impact on the development of more rapid, advanced microbiological methods (2). Amendments to the Steril…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The methods are well suited for routine use in the quality-control environment and the provided identification approach meets CFR, FDA, and other regulatory agencies requirements. As part of this appr…
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Biopharma in 2015: A Year for Approvals and Innovations
One of the most groundbreaking approvals occurred in March, when the FDA approved the first biosimilar in the US (years after the first such approval in Europe), Sandoz’s Zarxio (filgrastim-sndz). The…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
FDA has approved a bispecific antibody—Amgen’s Blincyto (blinatumomab)—for the treatment of refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blincyto targets cell surface proteins CD19 …