Search results for " variability"
Article
Reimagining Affordable Biosimilars
For biosimilars, factors that significantly impact affordability and development time include: development cost, variability in product quality, and low success rates of trials.
Cost of biosimil…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Techniques of measurement system analysis such as Gage repeatability and reproducibility (Gage R&R) studies are recommended because they provide information on the variability of the measurement syste…
Article
QbD and PAT in Upstream and Downstream Processing
The variability and complexities associated with the upstream biological process make QbD a complex process, one that relies on defining operation specific critical process parameters (CPPs). CPPs are…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A process parameter whose variability has an impact on a critical quality attribute and, therefore, should be monitored or controlled to ensure the process produces the desired quality.
• Critic…
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Understanding Validation and Technical Transfer, Part 3
…trates how some conventional validation approaches may not be applicable due to the inherent process variability and because of the low numbers of units produced.
In this example, the patient’…
Article
Continued Process Verification for Biopharma Manufacturing
For instance, when a process change or improvement shifts the mean or changes the variability, control limits should be re-set based on an appropriate number of results following the change.
The R…
Article
Quality by Design and Extractable and Leachable Testing
Within the design space, it is important to work with the packaging component supplier to understand what potential sources of variability exist for each packaging component, especially those with gre…
Article
Quality by design for biotechnology products—part 1
When a product is developed using a QbD approach, the impact of raw and starting materials and process parameters on product quality are well understood and the sources of process and product variabil…
Article
Addressing the Complex Nature of Downstream Processing with QbD
“Typically, process parameters and their variability are well characterized, whereas the interplay between them and, for instance, resin variability may represent a blind spot,” says Malmquist. The im…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Hahn agrees that data integrity is more at risk with higher data variability. “This is the case, for example, at the interfaces between upstream and downstream. An unidentified, or even unidentifiable…