Search results for " innovation" in Articles / App Notes
Article
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FDA Releases Draft Guidance on Emerging Manufacturing Technology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On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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…
Article
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…
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A Bright Future for the Plasma Fractionation Industry
In addition, a poster session allowed for an open discussion around some of the latest trends and innovations within the industry in combination with excellent networking opportunities.
The meet…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
Even though one of the key objectives of the Biologics Price Competition and Innovation Act (BPCIA) is to identify and limit the number of patents that can be the subject of litigation, according to E…
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New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue …