Jeanne Linke Northrop: What is the cell culture analytical testing and why would someone need it?
Alicia Elwood: Cell culture analytical testing allows us to observe what is happening with the cells in culture at a molecular level. Analytical testing provides quantitative data that can be used for multiple applications, such as understanding nutritional requirements of a cell line. Our cells utilize different components during their growth and productivity cycles—it is good to understand the level of those components. You can use it to characterize subculture system parameters for process optimizations. Optimal ranges can be determined for various components, and this allows you to keep your cells healthy and productive. You can use the information to extend cell viability and increase productivity—extending the cell viability by using feeds and timings can lead to increased productivity of the cells. Additionally, it could be used for investigating the cell culture performance. Variability occurs when a biological is involved, however, it is important to understand the ranges of optimal performance which helps put boundaries on variability. 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 culture. It allows us to make a better decision in the upstream process by understanding what is happening to the cells in culture. This may avoid bigger issues further down the process.
Jeanne Linke Northrop: What industries would need these analytical testing for cell culture?
Mary Szorik: We mainly work with biopharma companies that are producing therapeutic proteins, biosimilars, and monoclonal antibodies. This service is useful for smaller companies with limited resources. These companies cannot afford the set up and support an analytical testing laboratory. It can be expensive to purchase instrumentation and the capital expenditure. It is also necessary to train chemists and technicians in order to run the instrumentation. However, all companies do not have these resources available. Other companies that we support are in the cell and gene therapy industry. The companies that support biopharma’s such as contract manufacturing organizations or CMOs are participating in cell line or media development. We have been working with cultured meat industry, which is laboratory-grown meat. This is a new area of research; however, we have found that the spent media analysis can help support this industry. We are also able to support regenerative medicine product development—as well as beauty and cosmetics product development industry.
Jeanne Linke Northrop: How does analytical testing provide insight?
Mary Szorik: Analytical testing provides scientists with actual data that helps them understand their process better with information about what the cells are producing and consuming. The data helps the scientists to optimize their process to know when to adjust feed levels and other conditions to improve the productivity of their cells. Obtaining quantitative data helps reduce the risk and makes the process optimization smoother. We offer testing that includes glucose, glutamine, glutamate, lactate, ammonia, and ions such as sodium, potassium, and calcium. When a customer sends samples to a cell culture media supplier lab, they have the additional advantage of working with a team with media expertise. If a customer needs help with interpreting results, they can work with our field application specialist or our media development services. This is an advantage for our customers because they can work with one supplier who understands their whole process from media to testing to processing and process optimization. We also offer protein quality analysis, including charge variance, glycosylation, and protein aggregation. These types of results provide the scientists information on critical attributes of the protein product. It also helps them to be able to adjust their process to produce a product that meets the critical qualities. The results also help the scientists understand their ability and their process. The testing can be applicable to a wide variety of sample types, that includes chemically refined media and supplements, media containing serum or other animal products, and media containing hydrolysates. It can be applicable to many different cell lines, including CHO or HEK, insect cells, and cell lines used in the cultivated meats industries. Furthermore, we do not need to know anything about the customer's cell line to perform the testing—we do not need to know anything about their process. This may help alleviate any concerns about their IP and confidentiality.
Jeanne Linke Northrop: When is it most beneficial requesting these testing?
Alicia Elwood: It is beneficial to use this type of data early in the process. If you are aware of your cells’ nutritional needs, it may be easier to spot potential issues and adjust for optimization. Analytical testing provides a quantitative approach that delivers an insight of the cell and culture. It also improves the ability to spot issues before they become larger problems—and preventative measures are taken to create solutions for the future. It can provide process improvement by reducing the time it takes to reach the market. The information provides a foundation for a robust process with high productivity and consistent yields. Therefore, happy and healthy cells will be the most productive cells.