In this podcast and accompanying article, we interviewed Alyssa Master, Ph.D., Senior Manager of Science and Applications, Nucleus Biologics about some of the challenges of working with FBS, why not all FBS is created equal and suggestions for FBS customers who are trying to navigate these issues.
We began the interview by discussing why FBS is considered the gold standard of serums. Alyssa explained that FBS is a bi-product of the meat and dairy industry and it is great for in vitro cell growth because it contains a cocktail of growth factors. FBS is biochemically different from other sera like adult bovine serum or even newborn calf serum. Due to these biochemical differences, FBS has become the gold standard and as a result it is more expensive.
We then discussed why, with a desire in the industry to move to animal-free culture, does FBS remain so popular. Alyssa stated that because of its ability to support cells in vitro it is widely used throughout academia, biotech, large pharma and bioproduction, particularly in Cell Therapy and vaccine biomanufacturing. Alyssa went on to explain that since it works well for most lines and is readily available, it will always have a place in manufacturing.
Next, I asked Alyssa about some of the challenges facing customers using FBS. She identified the biggest challenges as consistency and price volatility. She said that the way the supply chain is structured in the serum industry, raw material suppliers can change frequently. This results in getting product from multiple locations and mixing it in an attempt to dilute the product to reach consistency. Genetics and food play a big role in the finished FBS product, so mixing leads to lot-to-lot variability. This variability makes testing FBS lots a must for most customers. She added, that it would be a great thing for scientists if they didn’t have to do that.
Price volatility is also a big issue. This happens due to a lot of economic factors but one of them is inconsistent sourcing. Lack of a dedicated source, makes companies have to keep changing the price because there isn’t a consistent supply. It’s even led to some cases of adulteration of product where calf serum or adult bovine serum is blended in to cut costs. Because of the biochemical differences that can appear in FBS due to feed, breed, origin, etc. these difference are not good for scientists who are relying on consistency for results.
Alyssa then shared how customers can deal with concerns about quality and cost. One of the ways customers can determine quality is by looking at the certificate of analysis and knowing what the tests mean and what is important for their particular experiments. For example, some cytokines are more relevant to certain cell models than others. Whenever you add animal source components to experiments, there is a risk. The best way to mitigate this risk is to thoroughly characterize the product so customers know what variables they’re adding to the experiment.
She then described how Nucleus Biologics deals with this issue. She said that Nucleus Biologics’ FBS has the most tests of any FBS in the industry. They want to be able to provide data to show high quality rather than just asking customers to take their word for it. In addition, if the customer’s experiment does fail, they are armed with as much data as possible about their reagents to figure out the cause.
She also said customers have to also think about country of origin and decide on their own level of risk tolerance. Some countries like Australia and NZ have very strict entry requirements for livestock and very stringent veterinary standards which makes product from these locations highly coveted. For example in Australia, they RFID chip all the animals, for the most part they are grass fed and antibiotic free. It’s very different from how things are done in the US. Not surprisingly this makes a difference in the FBS from these countries. Product from these locations have incredibly low risk for contamination compared to other places in the world. Of course, there is a limited supply of product available from these locations, so that does cause the price to be higher.
She summarized that as a scientist or a manufacturer, you have to think about product quality from a characterization standpoint and then the risk you are willing to take. Customers must ask themselves how and much does a failed experiment or production run cost in time, effort and resources.
I then asked Alyssa how as customer can ensure traceability and she described how Nucleus Biologics addresses it for their customers. Nucleus Biologics has complete control of their entire supply chain from raw material collection through processing to bottling. Nucleus Biologics FBS even comes with a Certificate of Traceability that includes information on the exact number of animals that went into that lot and their exact locations. No one else can do that because no one else has completely control over their supply chain and operations.
Next I asked Alyssa to share her advice on how to ensure you are getting the right FBS for your project whether it be for research or manufacturing. She said if you want consistent results then you have to think about quality. You want cosnsistency so that anyone can reproduce your experiments. Use of inconsistent reagents can make that difficult. So when you’re purchasing making sure you’re getting something that is highly characterized and has high lot-to-lot consistency.
I ended the interview by asking if she had anything else to add and she said that just like it is important to think about what we feed ourselves, it is very important to think about what we feed our cells. Ask suppliers questions about quality, traceability and what is the best product for their experiment. She said that she enjoys helping customers find the best product for their needs.