Search results for "supplements"
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 (…
Poster
Scale-up of CHO fed-batch cultures in HyClone™ ActiPro™ medium supplemented with Cell Boost™ 7a and 7b
Comparing cell growth and recombinant protein production of multiple Chinese hamster ovary (CHO) cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplement…
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 …
Article
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…
Article
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…
Article
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…
Poster
Benchmarking, scalability, and protein production in CHO cell culture
ActiPro cell culture medium and feed supplements has a tailored formulation that supports viable cell counts of more than 25 million cells per mL and protein production greater than 5 grams per liter…
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…