Search results for " production"
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EMA Collaborates with HTA Assessment Networks
This has helped to overcome concerns among Danish patients about production standards with biosimilars. Within less than two years, biosimilar somatropin, the growth hormone, rose from a market share …
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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
Paperwork and bureaucracy have increased to a point where they impede proper functioning of the quality and production systems. Management must look for new ways to provide the proper support, tools, …
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Sterilization Trends for Single-Use Consumables
Several sterilization process essentials
Contamination poses a huge risk to the production of biologic drug substances and drug products, making sterility assurance imperative, states Christy Eatmon…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
“Using model outputs linked with experimental and, where it exists, production data opens significant opportunities to apply machine learning techniques and build knowledge that has applications acros…
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Process Chromatography: Continuous Optimization
Ion exchange resins that offer high capacities at high linear flow rates help to scale-up processes for the economic production of large-volume mAb drugs, says Bulpin. “The base beads of these materia…
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Downstream Processing for Cell-Based Therapies
Unlike the traditional manufacture of monoclonal antibodies (mAbs) and other biologics, the production and processing of cellular material forms the basis of the product for CGTs (1). As such, manufac…
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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
…s of thought-provoking questions including “What metrics do manufacturers currently use to monitor production quality?” and “How frequently would such metrics need to be updated to be meaningful?”
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Applying GMPs to the BioPharma Supply Chain
At an operational level, it is vital that biopharmaceutical production is carefully controlled within defined parameters and there is no possibility of contamination. Suppliers share a commensurate re…