Search results for " design" in Articles / App Notes
Article
Cell-Culture Advances Test Bioreactor Performance Models
Traditional, reliable method
Typically, bench-top bioreactors are operated in the performance design space of larger bioreactors to model scale-up performance, according to Parrish M. Galliher, …
Article
Emerging Therapies Test Existing Bioanalytical Methods
In the case of chimeric antigen receptor T (CAR-T) cells, the construct and viral vector used for transduction are key in determining the design and type of assays required. The bioanalytical methods …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Factors that play a role in media design originate from three major sources, namely the attributes of the product under consideration, the cell line that is being used for protein production, and the …
Article
Fusion Proteins Pose Manufacturability Challenges
Early in 2017, for instance, Celgene acquired Delinia, which is developing DEL106, a novel IL-2 mutein Fc fusion protein designed to upregulate regulatory T cells (Tregs). Roche/Genentech is focused o…
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Being Thorough When Transferring Technology
Lonza: A mammalian process designed with insufficient appreciation of operability within a cGMP facility and lack of process understanding from the process transferring partner can increase the risk o…
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Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1), is designed to ensure that drug critical quality attributes (CQAs) are defined and maint…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Human and process-related risks
There are two main potential sources of contamination, according to Cyrill Kellerhals, COO at Andelyn Biosciences: operators and the facility design. “Proper trainin…
Article
Using Software in Process Validation
and requires a team effort that encompasses people from various disciplines within the plant?
It is important to design processes that ensure product quality, safety, and efficacy. Today’s soft…
Article
A Look at the Affinity Chromatography Landscape
Significant effort has in fact been directed at designing different libraries of affinity ligands so that structures of choice can be retrieved based on the application, according to Mario DiPaola, se…
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Putting Viral Clearance Capabilities to the Test
The studies must be designed to evaluate potential viruses, be representative of the production process, meet regulatory requirements, and provide reportable data. In addition, the testing should be c…