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…

Article 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…

Article 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…

Article 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…

Article FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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 …

Article 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…

Article 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…

Article 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 …

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