Search results for " guidance"
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Ligand-Binding Assays and the Determination of Biosimilarity
FDA, in its May 2014 draft guidance on how to show biosimilarity using clinical pharmacological data, indicated that LBAs, concentration and activity assays, and PD assays were important for biosimila…
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Viral Clearance Challenges in Bioprocessing
Viral clearance is assessed in small-scale tests, and regulatory guidance documents provide a general framework for how these tests should be performed (1). Even with guidance, however, demonstrating …
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Continued Process Verification for Biopharma Manufacturing
FDA’s January 2011 process validation guidance emphasizes the need for companies to organize and use acquired knowledge and continually improve throughout the process lifecycle by making adaptations t…
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Sterilization Trends for Single-Use Consumables
The standards also, Hatchcock adds, provide guidance on how to migrate from one technology, such as gamma, to another, such as X-ray.
Hathcock goes on to point out that not all SU components and s…
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Digitalization: The Route to Biopharma 4.0
One of the critical FDA guidance documents that applies to digitalization efforts is that of Part 11 of Title 21 of the Code of Federal Regulations (Electronic Records; Electronic Signatures). This do…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Sponsors gained important advice from FDA on conducting clinical trials during the pandemic from a steady stream of new guidance documents addressing the need for flexibility while maintaining study i…
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Maximum Output Starts with Optimized Upstream Processing
Across the industry, though, Vanek believes there has been a gap in investment capital for companies that have launched these innovative products but still require guidance to fully scale and industri…
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Remote Monitoring and Big Data Advance Upstream Automation
In some cases, these activities, which can include providing guidance and training to facility workers, proceed via remote connections available in the automation systems, while in others they take pl…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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Roadmap Leads to Innovative Biomanufacturing Strategies
For example, there is already a desire to make progress in certain workstreams so that they will be in a position to influence new guidance documents expected from the International Council for Harmon…