Search results for " process characterization" in Articles / App Notes
Article
Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
Article
Addressing the Complex Nature of Downstream Processing with QbD
The impact of variability regarding raw materials can be felt first in commercial manufacturing because of a lack of relevant test material during process characterization. “The only viable approach t…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
Article
Platform Approach Speeds Process Development
In addition, small-scale systems are a prerequisite for successful process characterization studies to provide reliable evidence that process parameters and associated critical product attributes are …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
These reasons force sponsors to initiate extensive process characterization studies and to lock the production processes early in the clinical development program (41).
One new approach to genera…
Article
Improving PAT for Biologics
The recent emphasis on establishing a thorough understanding of the manufacturing process from the earliest process design stages through the use of process characterization studies is, however, a key…
Article
Use of Multivariate Data Analysis in Bioprocessing
Thus, the usefulness of MVDA in supporting key activities of successful manufacturing of biopharmaceutical products including scale-up, process comparability, process characterization, and fault diagn…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
By Feliza Mirasol
The advancement of digit…