Search results for " critical parameters"
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
DoE Provides Benefits, but Preparation Is Necessary
At the same time, DoE results depend on the selected critical parameters and the sample material used in the studies. In addition, a large amount of data is generated. Consequently, reaping the benefi…
Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
Monitoring and Control of Inline Dilution Processes
To ensure robust performance, system blending, flow control, and monitoring of critical parameters must be considered,” she asserts.
Another important factor for consideration, according to Vermun…
Article
Being Thorough When Transferring Technology
This becomes invaluable to others later, and helps support claims for process characterization and robustness; selection of control and critical parameters; and setting of specifications. A summary of…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Modeling Bioreactor Performance
On the other hand, modeling is less appropriate when the model is unable to hold critical parameters at the level they will be in production scale, according to McHugh. “Typically all models are usefu…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…