Search results for " analytical" in Articles / App Notes
Article
Managing Risk in Raw Material Sourcing
…ng changes to manufacturing processes, raw materials, product specifications, product transfers, and analytical testing, be managed and approved in a structured, cross-functional way,” he says.
T…
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Advancing Single-Use Technology Through Collaboration
…hat answers common questions suppliers might have about the scope, study design, sample preparation, analytical methods, and reporting involved in extractables testing. “To me, a key reason some manu…
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Efforts Accelerate to Streamline Postapproval Change Process
…ded to increase batch size, shift to a new manufacturing facility, or improve process robustness and analytical methods.
Expanded global sourcing and sales complicates lifecycle product managemen…
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Perfusion in the 21st Century
Notably, because of the sophistication and efficacy of the controls used for all aspects of perfusion processes, such as pumps with feedback control or advanced in-line and on-line analytical tools, i…
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A Q&A with Eric Langer: CMOs Embrace New Technology
In comparison, biopharmaceutical innovators sought improved analytical assays and development, control systems, fill-finish services, and downstream PD services.
Why are CMOs early adopters?
…
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Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
What general trends do you see in single-use technologies within the biopharmaceutical industry?
We are now seeing standardization of materials testing data and corresponding analytical techniques…
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Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …