Search results for " control"
Article
Setting Up Bioprocessing Systems for Digital Transformation
Given the large-scale switch-over to single-use components in biopharmaceutical manufacturing, there is an urgent need to have greater control over manufacturing operations with single-use components,…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Specific examples include the adoption of single-use systems, particularly mobile systems designed for ballroom manufacturing and solutions that address the unique process control challenges associate…
Article
Using Software in Process Validation
It seems straightforward, but how does one achieve this when it involves a myriad of multiple systems (programmable logic controllers [PLCs], human-machine interfaces [HMIs], control systems, etc.) an…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
…ding of product quality attributes serves as the touchstone upon which process design and integrated control strategies are built.
Structural characterization is used to assess the CQAs of bioph…
Article
Quality by design for biotechnology products—part 1
…setting specifications, followed by the development of the design space and establishing the process control strategy; to later stages, including incorporating QbD into a regulatory filing and facili…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
A small-scale version of controlled freezing-thawing systems is useful for scale-down assessment of freeze-thaw process characterization (37). The authors, therefore, sought to assess the feasibility …
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 …