Search results for " innovation"
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Improving Upstream Predictability
“Significantly higher cell densities will result in challenges with respect to mixing and oxygen transfer, while new modalities such as cell and gene therapies will require innovation,” he says.
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Moving PAT from Concept to Reality
…rmance, according to Arpan Mukherjee, technical committee coordinator for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Raw-material characterization is performe…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
These recent innovations are better positioning exoglycosidases for routine use in analytical workflows that affect biologic drug analysis.
New problems, new solutions
An ongoing pharmaceutica…
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Automation Trend in Fill/Finish Reduces Contamination Risk
…oved process lines/equipment, increased outsourcing to contract manufacturing organizations, further innovation for fill/finish equipment, a scale-down of isolator units and automation, potent compou…
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The New World of Biopharmaceutical Manufacturing
Collaboration between stakeholders will also be critical to navigating the potentially conflicting goals of advancing standardization and technology innovation.
Langer (BioPlan Associate…
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Vaccine Development Faces Urgency and Challenges
Manufacturing challenges
In addition to support for innovation to achieve a sustainable and profitable vaccine industry, manufacturers hope to gain more streamlined vaccine development requirement…
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Framing Biopharma Success in 2016
Agility, flexibility, and a focus on science will allow external sources of innovation to be optimized. Reducing development complexity by streamlining functions and addressing unproductive infrastruc…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…
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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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Quality Systems Key to Lifecycle Drug Management
Nasr observed at the DIA workshop that lack of agreement on change management regulation has inhibited continual improvement and manufacturing innovation and has increased regulatory workloads for bot…