Search results for " design"
Article
Viral Clearance Challenges in Bioprocessing
“Current filters can be used in this application, but they were not designed to run under continuous and high throughput conditions like those required for media supply,” he observes. Filter vendors a…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
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Reimagining Affordable Biosimilars
With new configurations and solid-state designs, SPR has become a workhorse in protein and nucleic acid applications. The sensor surfaces have been modified to allow cell-based binding to mimic real-t…
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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, …
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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 …
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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 …
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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…
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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…