Search results for " productivity"
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EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
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The Need for Advanced Process Modeling for New Therapeutic Biologics
This allows for changes that can have orders of magnitude impacts on economics and looks at the best ways to achieve quality and productivity outcomes,” Sinclair concludes.
References
1. C.M.V…
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Process Chromatography: Continuous Optimization
Drug manufacturers are always seeking ways to improve the efficiency and productivity of chromatographic separations. Suppliers of chromatography resins are developing new resin chemistries and bindin…
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Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
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mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
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The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
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Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…