Search results for " process variability"

Article 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…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Article Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture process innovations include platform processes with high productivity and chemically defined culture media, which have helped to reduce process variability and complexity, improve efficie…

Article 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…

Article Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…

Article 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…

Article Using Digital Twins to Model Process Chromatography
… the dynamics and develop a design space that will function with simple controls even in the face of process variability. The challenges in implementing model-based control strategies are the ava…

Article Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development. Sep 1, 2014 By: Thomas A. Little, PhD BioPharm International Volume 27, Issue 9, pp. 46-49 A product’s or proc…

Article Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…

Article Process Development: 2020 Reflections and 2021 Possibilities
Another prominent topic of the year was process variability, which can significantly impact biomanufacturing outcomes and is influenced by various factors, including variations in process parameters o…

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