Search results for " innovation" in Articles / App Notes
Article
Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
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Ensuring the Biological Integrity of Raw Materials
Creasey, MilliporeSigma’s head of applied solutions strategic marketing and innovation tells Biopharm International. To reduce testing delays, MilliporeSigma offers its Milliflex Quantum system, a flu…
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The Tide Stays High
Deloitte, Balancing the R&D Equation: Measuring the Return from Pharmaceutical Innovation 2016.
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Efforts Accelerate to Streamline Postapproval Change Process
He sees Q12 as an opportunity to promote drug manufacturing innovation and continual improvement and to help regulators gain more confidence in a firm’s PQS for managing post-approval CMC changes.
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Microbiological Testing: Time is of the Essence
In addition, McKee notes that the changes to the rule promote innovation in the development of sterility testing and are thus paving the way for the use of novel methods such as adenosine triphosphate…
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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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Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
By Cynthia A. Challener
Vaccine development is a complicated process that can take many yea…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
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GMP Challenges for Advanced Therapy Medicinal Products
Academics seeking to arrange preclinical and clinical trials for their innovations are so concerned about the complexities of compliance with GMP that they try to avoid having them classified as ATMPs…
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Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…