Search results for " design"
Article
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
In April 2021, Tive, Persequor, and Itrazo joined forces in a similar collaboration designed to help improve traceability in the cold chain, with an emphasis on biopharmaceuticals. “With the COVID-19 …
Webcast
A route to deeper process understanding-Studying resin variability using a Process Characterization
Chromatography resin attributes can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
Ligand density is an important…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
“They shorten design–build–test–learn cycles and enable portable, on-demand biomanufacturing at the point-of-use.”
“Recent technical advances in cell-free protein synthesis technologies have be…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Advanced data lakes use connectors specifically designed to ensure that, as context is added to data, metadata are generated to paint a clear picture of what was added and when,” Lenich states.
Si…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Those process analytical technologies (PAT) are a critical part of control strategies that ensure continuous operation within the design space.
While …
Article
Updating Viral Clearance for New Biologic Modalities
Improvements in chromatographic separations designed to maximize HCP and impurity removal have often resulted in higher levels of viral clearance as well, he says, pointing to MilliporeSigma’s chromat…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
The best solution to managing risk factors is to use quality by design (QbD) to classify them, applying tools such as Ishikawa fishbone diagrams or failure mode and effects analysis (FMEA), agrees Luc…
Article
Good Manufacturing Practices: Challenges with Compliance
When a company can design processes that consistently meet all product quality attributes, then this not only meets the base expectations provided in the GMP regulations, it is actively pursuing excel…
Article
On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
Chromatography resin attributes, such as ligand density, can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
With a facility set up for single-use system operations, facility design can be simplified and can be executed in about half the time needed to build a traditional facility with reusable systems, Youn…