Search results for " variability" in Articles / App Notes
Article
Risk Assessment: Studying Chromatography Resin Variability
Click here to read the article >>
Many factors can give rise to process variability, such as variation in different process parameters or raw materials. This article focuses on process robu…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
48-64
The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems, because the variability in …
Article
Assessing Manufacturing Process Robustness
It focuses on the evaluation of intra- and inter-batch variability, and can be applied to both large- and small-molecule pharmaceuticals (9). This review process involves comprehensive process assessm…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Starting material variability
The raw materials for allogeneic cell therapies cannot be manufactured on demand, but instead, rely on a network of volunteer donors. This creates variability in cell…
Article
Use of Multivariate Data Analysis in Bioprocessing
They demonstrate the potential of MVDA to become an integral part of upstream process control by effectively eliminating the major sources of variability, thereby leading to significant improvement in…
Article
Improving PAT for Biologics
Implementing PAT for bioprocesses presents unique challenges given the greater complexity of cell-culture and fermentation processes, the variability of raw materials (particularly living organisms), …
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…