Search results for " critical parameters"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A CQA may be affected by critical parameters in several different unit operations (see the Cause-and-Effect Matrix in Part 1 of this article [5]). Characterization study plans may not be able to integ…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
From the initial risk assessment of critical parameters, experimental data from formal studies will confirm the criticality assignment—critical or not—and help to assess the level of impact to CQAs.
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
Article
QbD and PAT in Upstream and Downstream Processing
O2 pressure, catalyst concentration, and pH are examples of critical parameters. It is important to note that mAbs are currently the leading area of biopharmaceutical research. One of the key paramete…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
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Regulators have been en…
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Essentials in Establishing and Using Design Space
Misconception Two: Only critical parameters should be in a design space
Design space can include all parameters affecting product quality. Design space can include parameters that were held co…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Spivey and Lane
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Analytic considerations for upstream processing – covering Process Analytic Technology (PAT), time-savings versus off-line ana…