Search results for " variability"
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…
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Biosimilar Quality Requirements
…nd later on purified through a variety of technologies, they will naturally have inherent lot-to-lot variability in their quality characteristics. Thus, it is important to sufficiently characterize t…
Article
Driving Improved Access to Biosimilars
But another company developing a biosimilar would be using a different cell line, posing potential risk because of the inherent variability in complexity for biosimilars, specifically in the drug subs…
Article
Biosimilars: Making the Switch Comes with Challenges
The issue of variability
A drive was initiated to reassure doctors and patients including a pharmacovigilance action programme to encourage reporting of adverse effects, communications with patien…
Article
The Lifecycle Change of Process Validation and Analytical Testing
To detect a small change in a process or a process drift, the underlying variability of the process when operating 'normally' must be understood. Automated algorithms can fail. Typically, this can occ…
Article
Top Tips for Successful Development of Antibody Chromatography Processes
In this interview, Jakob Liderfelt, Product Manager at Cytiva, discusses main challenges faced during chromatography process development for mAbs and mAb variants such as fragments and bispecific a…
Article
Quality by design in biotherapeutics purification white paper
One of these challenges is how process developers might gain a deeper understanding for sources of variability and set mitigation strategies. This white paper summarizes information around resin varia…