Search results for " control" in Articles / App Notes
Article
Continuous Manufacturing: A Changing Processing Paradigm
…fact that continuous manufacturing reduces manual handling of products and allows for better process control. An agency representative said at an International Forum and Exhibition on Process Analyti…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
In this approach, criticality is used as a risk-based tool to drive control strategies (Stage 1), qualification protocols (Stage 2), and continued process verification (Stage 3). Overall, a clear road…
Article
Improving Upstream Predictability
…ents in most aspects of upstream processing, from bioreactor design and media development to process control, automation, and modeling.
Some of the most significant gains have been made in …
Article
Mapping a Route for Cell and Gene Therapy Process Development
Importantly, the process control strategy could be different for different cell therapy applications. “While production of large numbers of actively proliferating cells would be the primary focus for …
Article
Achieving Process Balance with Perfusion Bioreactors
“The most specific need is that the cell retention device and system to control the perfusion recirculation flow, cell bleed, and product-containing flow must be integrated with the bioreactor effecti…
Article
Tools for Continuous Bioprocessing Development
• Bioreactors themselves, which control this large number of parameters, are large, complex to operate, and have not been standardized.
• Standardization is hampered by use of various platforms and…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The common factor across all of these considerations is the need for better process understanding and control to ensure that quality objectives are met.
Advances in analytical instruments are one …
Article
Understanding Validation and Technical Transfer, Part 3
If controlled environments are necessary, validation studies should demonstrate their suitability.
Processing, holding, and expiration periods should be evaluated and established to ensure prod…
Article
Reconciling Sensor Communication Gaps
For most of the history of the biomanufacture of therapeutic proteins, in-process measurement and control focused on upstream operations. Historically, cell culture and fermentation persist longest am…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…