Search results for " cell"
Article
Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and supplier…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Mammalian cells meet these criteria quite efficiently by virtue of their post-translation modification system, and this has made them a dominant production system for the biopharmaceutical industry. M…
Article
Generating a Fully Processed Antibody
…r additional post-translational modifications not typically performed by Chinese hamster ovary (CHO) cells, and more recently, numerous different multispecific antibody platforms. Each of these class…
Article
New Therapies Present Scaling Challenges
By Feliza Mirasol
The approval of emerging biologic-based therapeutics—such as cell and gene therapies—presents challenges and decisions for drug companies looking to increase the manu…
Article
Downstream Processing for Cell-Based Therapies
Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been directed towar…
Article
Patenting Prospects for Cell-Based Therapies
By Kevin Noonan
Treatment using cell-based therapies is a rapidly advancing area of clinical research and development. It is also one that involves significant investment and, therefore, can b…
Article
Tools for Continuous Bioprocessing Development
For instance, in cell culture, the typical biopharmaceutical company uses at least a dozen different platforms, including shallow-well microtiter plates; deep-well microtiter plates; shake flasks; ben…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The presence of serum, culture harvest viability, turbidity, cell lysis reagents, contaminant DNA levels, and residual transfection agents are all upstream factors. Overall process scalability and rob…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
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This article discusses efforts to limit polymer degradation without significantly impeding cell growth. The authors were able to show that a single resin can be converted to films that lead…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
These approaches did not affect product quality and were effective for multiple cell lines and applicable for large-scale manufacturing.
Recombinant protein production in the biopharmaceutical …