Search results for " drug"
Article
Transformative Medicines Challenge FDA and Manufacturers
FDA reports that some 40 companies are developing CAR-T technologies for multiple indications and that it is monitoring more than 600 active investigational new drug applications (INDs) related to gen…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
… that may potentially impact the integrity and/or stability of those transgenes and, in turn, impact drug substance production. Provided is a comprehensive, risk-based transgene characterization stra…
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The Metrics of Quality Culture
The intent of FDA to establish quality metrics first emerged in 2012 when Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) enhancing FDA’s capability to proactively …
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Biopharma Advances Demand Specialized Expertise
This reorganization was designed to enhance quality drug assessment by realigning several elements of the preapproval and surveillance inspection process. Integrating risk-based review, GMP inspection…
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Pharma Investments Reflect Key Industry Trends
First is the shift to biologic-based drugs, which has occurred along with a dramatic increase in the productivity, mainly in terms of much higher titers, of biopharmaceutical processes. “While demand …
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Quality by design for biotechnology products—part 1
The QbD approach was introduced into the US Food and Drug Administration's chemistry, manufacturing, and controls (CMC) review process in 2004 with the aim of enhancing and modernizing the regulation …
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Understanding Validation and Technical Transfer, Part I
Large-molecule drug products and attendant manufacturing processes often involve complex syntheses and purification steps that differ substantially from those employed for small-molecule pharmaceutica…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Such approaches, the authorities predict, could reduce waste, prevent drug shortages, and avoid the scale-up and production challenges that can delay final approval of innovative breakthrough therapie…
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Using Quality by Design to Develop Robust Chromatographic Methods
The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
The concept of quality by des…
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Healthcare Reform in China
The government also kick-started public hospital reform to come up with a mechanism to segregate hospital management and operations, as well as the duties between drug prescriber and dispenser in 16 p…