Search results for " variability" in Articles / App Notes
Article
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…
Article
Mapping a Route for Cell and Gene Therapy Process Development
Any production system that is used must also ensure that processes are robust enough to enable the use of raw/starting materials with significant variability, adds Lamproye. “For instance, the variati…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
Article
Regulatory Challenges in the QbD Paradigm
The intent was to allow for corrections in real time for the manufacture of quality product with less variability and with the expected attributes. Furthermore, this principle led to Six Sigma process…