We began the interview by talking about how FBS has evolved to include several different product quality levels to meet the needs of end users. Chris shared that in the 14 years that he has been working with FBS that there has been an increasing number of tests performed to meet specific application requirements. Twenty to thirty years ago there were far fewer tests conducted, now Gibco sera runs up to 96 tests to give serum a more defined scope.
Next, I asked Chris about serum origination as one way to differentiate serum, how important is it and what does it tell consumers. He explained that there are two areas where origin can be important. The first is with respect to viruses. There are some countries that still have viruses like foot and mouth and blue tongue, for example. So, it can be important to understand the origin.
The other area where origin is important is in regulatory requirements. FBS from certain countries can’t enter other countries due to regulations, thus it is important to be mindful of serum origin and the FBS import requirements for your country.
He went on to describe a recent study that Thermo Fisher Scientific conducted. The study took 18 months to complete and involved over 500 researchers. In the study, they surveyed researchers about the specifications that were most helpful to them in determining what they would purchase. Fifteen specifications came back as most important with the origin being number 12. This was a surprise as they expected origin to be higher on the list. It turned out that endotoxin, hemoglobin, total protein and filtration quality made the top of the list, but origin wasn’t in the top 10.
I thought this study was very interesting and asked Chris what were some of the characteristics of FBS that end users were looking for most. He said that endotoxin was number one as it can really define the quality of serum. Endotoxin is measured at collection and it demonstrates how well the raw serum was collected. For instance, was it collected using a closed system and aseptic techniques. Once you have that endotoxin number, it can’t be changed, so it gives researchers a real look at how carefully collection was conducted. This in turn is an indication of whether the serum was exposed to any other contaminants that would hinder research. As such, endotoxin serves as a real quality marker. In addition to endotoxin, hemoglobin, total protein, osmolarity, pH, and filtration were listed as specifications that help researchers decide what to buy.
Next I asked Chris about Thermo Fisher Scientific’s FBS categories and how they are designed to help researchers find the best product for their needs. He said that they recently changed their categorization from five categories to three. They made the change because with five categories there was too much overlap between product specifications and it was difficult to understand the product differences. The team looked at the entire portfolio and compared this to the responses that they had received in the survey to develop a system that was easier to navigate. The new categories are Value (up to 50 tests), Premium (up to 96 tests), and Specialty where products are delineated for specific applications. It became easy for customers to make decisions between the three based on the culture requirements of cells they were using and their specific application.
I followed up by asking about Specialty FBS and their custom options. Chris explained that they do have custom options available and a team that works with researchers to find the serum that best meets their needs, timeline and budget. However he also shared that before custom, customers should look at the Gibco portfolio of products to see if there is a non-custom match. He also described their iMatch program, a sera lot matching tool. Researchers can enter their FBS requirements and the program will search current inventory to find a match. If the match is 80% or greater, Thermo Fisher Scientific considers it an iMatch guarantee, which means they are confident that customers will see the same consistency as with past lots of FBS with the same requirements.
We then discussed cost and factors that can affect pricing. Chris explained that the cost and supply dynamic for FBS can be difficult to predict. He recommends that researchers work closely with suppliers to see if they have any insight on pricing changes to help plan purchasing for the future. Of course there are factors like drought, storms or geopolitical issues that can’t be predicted, but buying in larger quantities for a year or 18 month supply can help to combat pricing fluctuations. In addition, with larger purchases there are more discounts available and cost is locked in for the supply purchased.
We then talked about how selecting an FBS can be quite confusing and I asked Chris what he recommends to researchers who are unsure about finding the right FBS for their application. He agreed and said that one thing that can make selection even more challenging is that there isn’t a standardized Certificate of Analysis (CofA) or naming convention to help customers compare serums across brands. This is something that the International Serum Industry Association (ISIA) is working on, but in the meantime he recommends that researchers really look at the CofA for each serum to understand the details behind brand names or categories. It is important to be sure that researchers are comparing two like products. It is also good practice to compare the new product’s CofA to your previous FBS lot’s CofA to best understand how the new product will perform in your cell culture system.
I closed by asking Chris if he had anything else to add for listeners, specifically any new products or technologies on the horizon. He shared that Gibco has launched two new FBS products which were designed to give researchers even more information about the serum they are purchasing.
The first product is their Tet System Approved FBS that is functionally tested to ensure optimal induction for protein and gene expression systems. Tet-System Approved FBS is specially tested for cell culture applications using tetracycline and tetracycline-derivative regulated gene expression systems. Cell-based assays that detect the presence of tetracycline and tetracycline analogs are used to select FBS that delivers highest range of induction. The Tet System Approved FBS will be available in all the innovative packaging options including the 500 mL Boxy bottle and the One Shot 50 mL bottle.
The second product is their Premium Plus FBS with 96 quality tests, including functionality testing in six commonly used cell lines to test the consistency of cell proliferation. To be released, Premium Plus FBS must be greater than 80% of the control for cell proliferation. They also have growth, cloning and plating release specifications that must be greater than 80% of the control. The endotoxin specification is best in class at ≤1 EU/mL. Thermo Fisher Scientific developed this product to answer the demand for a more stringent quality serum, which is ideal for vaccine, therapeutic, diagnostic, and other demanding research applications.
Learn more about Gibco sera’s commitment to quality and innovation since 1962 at thermofisher.com/fbs