Search results for " FDA"
Article
Top Process Development Trends for 2021 and a Look into 2022
Another aspect of this is the manufacturing process and its robustness as it pertains to compliance with process validation requirements set forth by the FDA and ICH (International Council for Harmoni…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
COVID-19 vaccines, approved under emergency use authorization, were not required to meet serialization requirements, but they have been properly labelled to meet FDA requirements, he says, complete wi…
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High-Quality Chromatography System Meets Predesigned DeltaV for Integrated Manufacturing
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Nearly 50% of the warning letters issued by the FDA cite 21 CFR data integrity violations. Implementing a distributed control system for facility-wide control of …
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Getting Your Investigational Drug Regulatory Ready
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Navigating regulatory requirements can be overwhelming. This article outlines basic strategies for efficient regulatory review and drug approval.
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Selecting Chromatography Formats for Your Process Development Workflow
The quality-by-design initiative by the FDA puts additional demands on process development work because a higher degree of process understanding is needed.
Therefore, the choice of tools is critic…
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Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
It has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by FDA as part of Phase I, Phase I…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Although the industry as a whole has been slow to adopt these techniques, FDA actively encourages continuous production, and companies such as Sanofi and WuXi Biologics have made significant investmen…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
2019 proved to be an exciting year for biopharmaceutical developers and process engineers, filled with both advancements and lessons. Considering how far the industry has come, what direction will 2…
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
By Feliza Mirasol
With the recent FDA approvals and commercialization of cell and gene therapies in the US market and a pipeline of cell and gene therapies progressing toward regulatory review, …