How COVID-19 has affected Biotech's Supply Chain


Hello and welcome to the very first of the video series we're calling Carl Chats. Today, you'll be hearing from two Rockland veterans. Our chief scientific officer, Dr. Carl Ascoli has been with Rockland for the past 30 years. Carl plays an active role at Rockland and is also known as a key opinion leader in our industry with publications on antibody validation and reproducibility, and more recently, the COVID-19 virus.

Speaking with Carl today is Todd Giardiello, a product manager at Rockland, who's played various roles for the past 13 years, but more recently has been tasked with our COVID-19 efforts, coordinating our COVID research assistance program and the development of our very successful SARS-CoV-2 antibodies and supporting reagents. Today, Todd and Carl will be discussing the COVID-19 virus and the effect that it has had and continues to have on the global supply chain.

So without further ado, let's begin.

Todd Giardiello: All right. I'd like to begin with a brief overview of COVID-19, starting with why some coronaviruses give us mild colds while the virus that causes COVID-19 has more severe effects.

Dr. Carl Ascoli: Coronaviruses are respiratory viruses when they infect mammals and birds, and they have other types of illnesses in other animals. Some coronaviruses have little effect or very mild effect. Other coronaviruses have very severe effects and can result in death.

Todd Giardiello: So when we first recognized that this was a new virus in the world, many academic institutions either shut down their other programs that weren't related or funneled a lot of funding into researching this virus. Did those collaborations really help us understand the virus in a better way?

Dr. Carl Ascoli: Yes, absolutely. SARS-CoV-2, the virus that causes COVID-19 is generally thought to be a respiratory virus. Certainly the general public thinks of it that way. But many studies have been done that have resulted in peer-reviewed articles published and in top tier journals really throughout the world have shown that when highly specific antibodies for SARS-CoV-2 are used, the virus is present in many tissues and organs other than just lung. There have been studies showing SARS-CoV-2 in brain, in liver, in gallbladder, in muscle, in placenta, and many other tissues. I think it's going to take quite a lot of time for researchers to really understand the biology of this virus and understand what the long-term consequences are of infection, especially when the virus is present in tissues other than lung.

Todd Giardiello: So this work research was being done by researchers and institutions from around the globe. So let's talk for a minute about the global supply chain. How did the COVID-19 pandemic really shine a light on the biotechnology supply chain?

Dr. Carl Ascoli: Well, there has been a trend to outsource critical reagent development for R&D and for the in vitro diagnostic industry, as well as biotherapeutics to a global marketplace, not only just over the last few years, but perhaps a decade or more. And a lot of that offshoring has been done to areas like China, specifically the Hubei province, where Wuhan is the capital city. And when the SARS-CoV-2 pandemic really came into being, that entire region of China was completely shut down. Every aspect of life stopped. And so multi-billion-dollar industries, automotive, electronics, mining and health care were significantly impacted by a total shutdown of manufacture and distribution coming out of that region.

Todd Giardiello: What do you believe are the main obstacles in establishing a stable, long-term supply chain?

Dr. Carl Ascoli: Well, there needs to be good planning, and risk mitigation strategies are a part of good planning. Companies and industries, in fact, may want to reevaluate or rethink the offshoring of critical reagent development, or at least manage it in a different way so that the vulnerability of all of these industries, including the health care industry, is lessened if a supply chain interruption like this one happens again in the near future.

For researchers, risk mitigation strategies mean different things for different groups of people. If you're a researcher and you're performing work, planning is so important. And if you identify a critical reagent, whether it's an antibody or an ELISA kit, whatever is necessary for you to complete your work. Once you determine through validating that, let's say, an antibody in your laboratory, that that's essential for your work, you should purchase all of the material that you need at the onset of your work and store it in your own laboratory. You want that same material, that same lot number to do all the experiments that you may need to do, even if it spans a few years.

Generally, materials are very safely stored for long terms. For instance, antibodies at cold temperatures. So that's not an issue. If you run out of the material, it may be very difficult to reproduce your work, especially if there's a supply chain interruption. Perhaps the most vulnerable type of critical reagent if we're talking about immunoassays are ELISA kits.

Consider what's in an ELISA kit. You have a primary antibody, a secondary antibody, blocking buffers, stabilizers, substrates, so many different components, controls, standards. All you need is one of these components in a kit to be caught up in a shortage that's due to a supply chain interruption. And you may no longer have that kit available to do your work.

Planning ahead is the best way. Buy a sufficient amount of this material, keep it on your shelf where you know you have access to it. Regardless of what might be going on with insecurities and supply chains.

Todd Giardiello: You had mentioned that critical reagents in immunoassays are not just the antibodies detecting the pathogens or the disease markers. Can supply chain instability affect the other products as well?

Dr. Carl Ascoli: Oh, without a doubt. For instance, consider mouse serum. Mouse serum can be used in its native state. You can purify gamma globulin from it, you can purify mouse IgG from it, and it can be used in so many different ways. In research, it's used in, let's say, milligram quantities. In the IVD industry in can be used in kilogram quantities. It can be used as a dilution, a stabilizer, it can be used in flow cytometry as a control, in coating biomagnetic particles, in the preparation of biosensors. It can be used in so many ways.

The labor costs in producing mouse serum are incredibly high. It's prohibitive to do it in developed countries like the United States and Western Europe. So a great amount of mouse serum is produced on a global scale and a lot of it is made in China in the Hubei province. So when the COVID-19 pandemic struck, literally the global supply of mouse serum and its derivative products came to a complete halt. There was no material. No material could be found anywhere unless you had a manufacturer or supplier that deployed really good risk mitigation strategies. And there are strategies that could defend against shortages like this, even for things like mouse serum.

Todd Giardiello: So how can a critical reagent supplier help a diagnostic manufacturer?

Dr. Carl Ascoli: Well, there's this mindset that I guess has become very current, very popular over the last few decades of just-in-time sourcing of critical materials. For instance, there's no need to warehouse it in your facility. FedEx or UPS or whomever can ship it to you overnight. So that's great. Unless there's a supply chain interruption. And the risk mitigation strategy there is to have a deep reserve or a deep inventory of material. For instance, Rockland immunochemicals as a critical reagent supplier to the in vitro diagnostic industry for mouse serum had a reserve of thousands of liters of mouse serum.

And we were able to see our in vitro diagnostic manufacture clients through the tough time because we actually had a reserve of material in the United States to provide to them to use carefully for those critical projects to get through the shortages that the global pandemic and supply chain instability caused. So there's this, it's almost like a yin and the yang. On one side, you have deep, deep reserves of inventory, on the other side some may have the mentality of a just-in-time supply and distribution. Just-in-time works if there's no interruption to the supply chain. But if there is, you better have a deep reserve of material.

Todd Giardiello: Great. There's a lot of good information in there, and it's always an enlightening experience whenever we get to chat. So thank you for your time. Dr. Ascoli.

Dr. Carl Ascoli: Thank you, Todd.

Thanks for watching. We hope you enjoyed our first Carl chat video. Be sure to stay tuned for our next conversation where Todd and Carl will discuss the role of amino acids as it relates to COVID-19 vaccines and therapeutics. If you'd like to learn more about our COVID Research Assistance Program or our COVID-19 antibodies and supporting reagents, be sure to check out our website.