Search results for "regulatory" in Articles / App Notes
Article
Remote Monitoring and Big Data Advance Upstream Automation
…contamination risks, batch characterization, process integration issues; infrastructure challenges; regulatory authority resistance; and access to people with the right combination of skills and abil…
Article
Technology Innovations Improve Process Chromatography Performance
“We are also seeing that, as regulatory limits impose restrictions for ensuring customer safety, like toxicology and cleaning validation for GMP [good manufacturing practices] environments, off-the-sh…
Article
Scalable Viral Vector Manufacturing
From a regulatory perspective, it is recommended to avoid any raw materials that are of animal origin such as serum and other components as these could potentially contain adventitious agents.
Is …
Article
Perfusion in the 21st Century
Equipment limitations, such as the lack of good aseptic connectors, marginal pump accuracy, and inadequate on-line monitoring, led to technical problems and regulatory uncertainties. There were questi…
Article
Tools for Continuous Bioprocessing Development
These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.
The ability to codify…
Article
Optimization of Protein Expression in Escherichia Coli
If greater control is desired, vectors containing the rhaBAD promoter—including the two regulatory genes RhaS and RhaR—allow protein expression to be tuned more efficiently (4).
The Rhamex vectors …
Article
Raw Material Variability
Moreover, with increased regulatory expectations, it is difficult to claim ‘we are in control’. Health authorities want to see process understanding, and they want to know that supplier quality is sui…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Comparison to regulatory specifications
As there is no approved cell-based LAIV on the market today, no regulatory requirements in terms of impurities are established. Hence, the output from the s…
Article
Introducing the VH3 ligand ELISA kit
Accurate testing for ligand leakage from affinity resins is a key part of this process, ensuring compliance with regulatory standards.
Our new VH3 ligand ELISA kit - the latest addition to Cytiva…
Article
Evaluating the Use of Continuous Chromatography
While regulatory agencies express interest in supporting the use of continuous processing, many companies continue to develop batch purifications first, before evaluating whether a continuous chromato…