Search results for "supplements" in Articles / App Notes
Article
Fed-batch supplements to boost cell culture performance
This application note demonstrates the enhanced performance of commonly used cell lines for MAb production when supplemented with HyClone™ cell culture supplements. Cultures of Chinese hamster ovary (…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Establishing the role of numerous media components and supplements upon product quantity and quality is of paramount importance in media optimization with a focus upon reduced production of undesired …
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Regulatory Challenges in the QbD Paradigm
Regulators also must offer more flexibility regarding manufacturing changes and application supplements based on science and risk assessment, so that limited resources on both the industry and regulat…
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Quality Systems Key to Lifecycle Drug Management
These developments reflect the struggle for regulators trying to review thousands of supplements, and for manufacturers implementing changes in products and manufacturing facilities around the world. …
Article
New Era for Generic Drugs
…ow the program’s success has generated thousands of abbreviated new drug applications (ANDAs) and supplements that are requiring major operational changes at FDA. Hatch-Waxman also has generated a ho…
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Optimizing your Cell Culture Process to Improve Productivity
It could also be used to analyze monoclonal antibody protein quality by examining the parameters, supplements, and feed timings, which may help increase the quality of the protein being produced in cu…
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Optimization of Fed‑Batch Culture Conditions for a mAb‑Producing CHO Cell Line
The selected Cell Boost supplements were thereafter applied in fed-batch cultures to fine-tune their relative ratios. The selected fed-batch culture conditions supported mAb titers of approximately 4 …
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Replacing complex bovine serum supplements with purified bovine proteins such as albumin, insulin, transferrin, and fetuin was seen as a major advantage in the early days of serum-free media technolog…