Q. How does your product impact downstream purification?

A. To date, we have not seen any effect on HPLC purification. Additionally, because Cell-Ess increases productivity without increasing viable cell density, there is no added bio-burden or host cell protein to eliminate during downstream processing.

Q. Is there any impact to the metabolic profile?

A. Cell-Ess®, while increasing protein production, does not alter the metabolic profile of many common metabolites. As an example, glutamate, lactate, and ammonia are similar to the control groups with no Cell-Ess added.

Q. Can peak protein yield be extended using Cell-Ess?

A. Yes, the increase in protein production occurs early and stays higher than control.

Q. Each time we add lipids to our media, we must make fresh solution and titrate the appropriate amount to add to avoid cell death. Do we have to do the same process with Cell-Ess?

A. Free fatty acid and free cholesterol are difficult to solubilize and are not stable in aqueous media. Sometimes a carrier is used as an alternative to ethanol as a method to solubilize free cholesterol, but the carrier can also be problematic. Solubility, stability and functional amount of cholesterol and free fatty acids have to be monitored and accounted for in cultures lasting over 4 days. Media depletion becomes an issue in longer cultures, and feeds are used to replenish missing constituents, including fatty acids and cholesterol. However, providing fatty acids and cholesterol in a feed can be problematic, because free fatty acids, free cholesterol or cholesterol with a carrier can be toxic in extended cultures. Therefore, extra steps, such as titration, are often employed in order to avoid the issues of stability, toxicity and variability of fatty acids and cholesterol.
Cell-Ess deploys a novel method of delivery overcoming the issues of stability, toxicity and variability. Because Cell-Ess is stable in solution, the extra steps are not required.

Q. Have you looked at the effect of Cell-Ess on glycosylation?

A. Cell-Ess does not significantly alter the glycosylation pattern. In fact, we have preliminary evidence to suggest Cell-Ess may create an environment for more reproducible glycosylation profiles.

Q. How is Cell-Ess manufactured?

A. Cell-Ess is produced in the USA under ISO-certified and cGMP compliance, and we are capable of providing a DMF if needed. We can also provide an MSDS and CoA upon request.

Q. Can you provide a standardized protocol to test Cell-Ess?

A. Cell-Ess was designed to be used for a variety of different applications, across a variety of different cell and media schemes. For this reason, Cell-Ess is able to be customized to fit into your needs. We recommend having a short phone conversation to discuss your process and desired outcome. At that time, we can provide recommendations for how to use Cell-Ess to best set you up for success.

Q. What is the shelf-life of Cell-Ess?

A. Shelf life of Cell-Ess liquid base is 1 year from the date of manufacture when stored at 2 -8 C, avoiding light.  However, once you add the lyophilized growth factors to the liquid component, the complete media will have a life of 4-6 weeks at 4 degrees and a life of 2-3 days at 37 degrees.  You can prepare a glycerol stock of the growth factors and only add as much growth factor as you need to extend the life of Cell-Ess liquid base, if required.

Q. Have you used Cell-Ess in perfusion systems?

A. We haven’t tested that directly. We do not know how the cells would behave when the media is fully turned over daily.

Q. Have you used Cell-Ess in perfusion systems?

A. We haven’t tested that directly. We do not know how the cells would behave when the media is fully turned over daily.

Q. With titers at 3 g/L or in most cases even better, we aren’t necessarily looking for improved titer. Are there benefits to be gained?

A. There are two different potential benefits. First, when we have used Cell-Ess as a feed, we found that increased output occurred early, so there is increased operational flexibility to stop a run early. We reached max yield of the control group 2 days earlier than in the control. Second, the quality of a protein is regulated on the lipid membranes of the endoplasmic reticulum and Golgi apparatus. Cell-Ess may support better health of both of these organelles, which may lead to more consistent protein quality.

Q. What systems has Cell-Ess been used with for production of therapeutic proteins?

A. Cell-Ess has been primarily tested in monoclonal antibody production using stably-transfected CHO cell clones. Cell-Ess has been tested in three unique media systems with different monoclonal clones, and varying lengths of manufacturing time.


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