Search results for " control" in Articles / App Notes
Article
Evaluating the Use of Continuous Chromatography
In addition, continuous processing intensifies production and lowers capital costs, while enabling better control (1).
Although significant strides have been made to advance continuous upstream pr…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of paramet…
Article
Being Thorough When Transferring Technology
This requires an understanding of what the rate limiting or controlling phenomena are and at each scale. What is limiting or rate controlling at the small scale often is not at the large scale. That i…
Article
Continued Process Verification for Biopharma Manufacturing
Some elements of CPV overlap with existing GMP systems such as the generation of data for batch release (BR) decisions, annual product review (APR), and change control.
In general, the nature and …
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
Automating the Biomanufacturing Process
As a result, data integration is needed to handle the huge increase in product data from this growth to ensure that these raw data become information that can be used to control and improve the proces…
Article
Selecting a Comprehensive Bioburden Reduction Plan
…eduction?
Mittelman and Anicetti (PDA task force): The most important consideration in bioburden control is staff training at all levels within an organization. The planning process needs to invo…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
The 1X medium was used as a control. Feed media with concentrations of 1X, 1.30X, 1.60X, 1.75X, 1.90X, and 2.50X were prepared by adding 10 N NaOH to increase the pH and dissolve all of the components…
Article
The Lifecycle Change of Process Validation and Analytical Testing
…gh the implementation of process analytical testing (PAT) technologies to support the monitoring and control of product critical to quality attributes. I think material understanding throughout the m…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
It also allows the development of an optimal process with a suitable control strategy and test methods in a timely fashion.
The implementation of a risk-based strategy for the testing of residua…