Search results for " process control"
Article
Assessing Manufacturing Process Robustness
Part B is a diagnostic study of the current process control (a seven-step product assessment process) that results in determining the adequacy of the current control strategy.
Part A. Com…
Article
Being Thorough When Transferring Technology
Therefore, the process controls that were identified and demonstrated during process validation studies to maintain consistent and reproducible manufacturing processes and product critical quality att…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In-line, continuous monitoring, and control systems, such as those associated with PAT, are helpful in maintaining and assuring process control. Assurance of process control can be obtained by observa…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
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
Regulatory Challenges in the QbD Paradigm
…elopment that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management" (5).
The publication of F…
Article
Moving PAT from Concept to Reality
…ents cause a delay between sampling and availability of the results, preventing their use for direct process control.
Still on the learning curve
The biopharmaceutical industry and regulatory…
Article
Quality by design for biotechnology products—part 1
…tes and 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 an…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
Both, according to Cameau, offer more process control than flatware systems because bioreactors include sensors for monitoring of pH, dissolved oxygen (DO), carbon dioxide percentage, and other parame…
Article
Achieving Process Balance with Perfusion Bioreactors
“Multivariate data analysis (MVDA) using software such as our SIMCA online system allows efficient process control and early fault detection by looking for differences from the ‘golden batch’,” Adams …