Tag: <span>media supplement</span>

Glycosylation drives protein quality and therapeutic benefits in protein-based therapies. Recently, there has been a push in the pharmaceutical industry to improve the consistency and quality of the glycan patterns on therapeutic proteins like monoclonal antibodies. Post-translational modification begins in the endoplasmic reticulum but is finished in the Golgi where more complex glycans are added. In this study, the addition of lipids via a novel mechanism provided by the medium supplement, Cell-Ess®, improves the consistency in glycan patterns so that they are more reproducible between product batches. The effect of media supplementation with Cell-Ess on the variation of glycan patterns was measured in two different media formulations across two separate experiments. Supplementation with Cell-Ess resulted in a statistically significant reduction in the variation of glycoforms when measured by the standard error of the mean. In addition, to improved consistency, there were increased higher glycoforms or galactosylation. There was also significantly more total galactosylation and significantly fewer lower glycoforms for antibodies produced by CHO cells supplemented with Cell-Ess. These data taken together suggest that the addition of lipids via Cell-Ess results in a more functional Golgi and an associated improvement of protein quality and consistency…

Biologics Production Uncategorized

Optimization of the key factors in a biopharmaceutical process is necessary to meet the continuous rise in the production demands. One of the key factors in the process addresses the diverse nutritional and growth requirements of the cell culture—peptone supplementation. Peptones are low molecular weight protein digests, which provide nutrients such as amino acids, peptides, vitamins, and minerals to the culture medium. They are widely accepted as the supplements that enhance the performance of a chemically-defined cell culture medium, and have successfully been used for over thirty years…

Biologics Production

The biopharmaceutical industry has seen a major shift away from the use of serum and other animal-derived components in the manufacture of biopharmaceuticals.  Guidance from the EMEA and FDA for the manufacture of biopharmaceuticals and medical devices encourages the use of “animal free” components to lessen concerns over contamination from adventitious agents such as prions, a cause of spongiform encephalopathy…

Manufacturing