Search results for " Design Space"
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
By using DoE, it is possible to reduce the number of cultures necessary to characterize the process design space. By reducing the ability of the model to detect higher-order interactions—so that main …
Article
DoE Provides Benefits, but Preparation Is Necessary
28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist to examine the formulation design space in a statistically significant manner from the beginning of ex…
Article
QbD and PAT in Upstream and Downstream Processing
However, with current bioreactor engineering controls, these parameters may be tightly and confidently controlled within the design space of the manufacturing process permitting these parameters to be…
Article
Digitalization: The Route to Biopharma 4.0
…well as reducing the number of experiments that would be required, ensuring process operation in the design space, real-time monitoring, and process diagnosis and prognosis. Implementation of Industr…
Article
Regulatory Challenges in the QbD Paradigm
In QbD, the product defines the process, so as long as the process stays within the defined design space, product quality is acceptable. Product specifications in the traditional approach are set base…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
PDA's Technical Report for Biotech Cleaning Validation
LeBlanc
ABSTRACT
Quality by Design principles such as design space can also be applied to cleaning validation. As discussed in the recently published PDA Technical Report No. 49: Points to Consi…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
In Part III, the control strategy for the process was developed from a design space established from characterization studies. As the process-qualification stage proceeds, the continuum of criticality…
Article
Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
Article
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
natali_mis/Stock.Adobe.com
Regulators have been en…