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8. American Type Culture Collection: A Model for Biological Materials Resource Management
– Frank Simione
25

American Type Culture Collection

I am not going to talk about what we do at the American Type Culture Collection (ATCC), but rather about the question of why we do it. I have been with the organization for a long time, and I have watched the evolution of what we do. In my opinion it is a successful model because we have been able to survive and thrive as an organization by using it, although some will contend it is not an ideal model

I will begin with a brief overview of the ATCC to show you how we evolved to this point, and then I will describe our operational focus, which offers some insight as to why we operate the way we do. The ATCC is a non-profit 501(c)(3) organization under the U.S. Code, and we are not part of the government, although some people who do not know us well think that we are. ATCC was founded in 1925. However the core collection really originated with the Winslow Collection at the Museum of Natural History in New York prior to 1925, so we can claim nearly 100 years of experience and expertise.

As mentioned in an earlier talk, in 1899, at the first meeting of the Society of American Bacteriologists a group of bacteriologists met and had a discussion about creating a collection of biological materials that the microbiologists could contribute to and draw upon. C.E.A Winslow started that collection at the Museum of Natural History, which eventually became the ATCC. It is now a diverse collection in life sciences that does not consist only of microbes, but also includes cell lines and other biological materials, because we are continually trying to keep up with what is going on in science.

We are, along with the Agricultural Research Services Collection (formerly NRRL), one of the first International Depository Authorities (IDAs) officially recognized in 1981 as a depository for materials used in support of life science patent applications. We are also a global distributor with the capability to move materials all over the world. For example, we have a contract with the Centers for Disease Control and Prevention (CDC) to develop an influenza reagent resource and manage it, and part of our service included providing support for the response to the H1N1 virus outbreak when it hit in May of this year. In response we assisted the CDC and the World Health Organization (WHO) in delivering diagnostic kits to laboratories in 133 countries in a very short time period. The WHO noted that this was the fastest response to a global disease outbreak it had ever experienced. ATCC did not develop the kits, however we assisted in their manufacture and assembly, and we distributed them.

ATCC is ISO 9001 certified, and ISO Guide 34 and ISO 17025 accredited. ISO Guide 34 establishes the requirements for reference material standards manufacture, and ISO 17025 establishes the requirements for laboratory testing. These accreditations support the activities of ATCC as a material standards provider. We are also accredited by the American National Standards Institute (ANSI) as a Standards Development Organization (SDO). ANSI accredits organizations that develop written consensus

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25 Presentation slides available at http://sites.nationalacademies.org/xpedio/idcplg?IdcService=GET_FILE&dDocName=PGA_053677&RevisionSelectionMethod=Latest.



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8. American Type Culture Collection: A Model for Biological Materials Resource Management – Frank Simione25 American Type Culture Collection I am not going to talk about what we do at the American Type Culture Collection (ATCC), but rather about the question of why we do it. I have been with the organization for a long time, and I have watched the evolution of what we do. In my opinion it is a successful model because we have been able to survive and thrive as an organization by using it, although some will contend it is not an ideal model I will begin with a brief overview of the ATCC to show you how we evolved to this point, and then I will describe our operational focus, which offers some insight as to why we operate the way we do. The ATCC is a non-profit 501(c)(3) organization under the U.S. Code, and we are not part of the government, although some people who do not know us well think that we are. ATCC was founded in 1925. However the core collection really originated with the Winslow Collection at the Museum of Natural History in New York prior to 1925, so we can claim nearly 100 years of experience and expertise. As mentioned in an earlier talk, in 1899, at the first meeting of the Society of American Bacteriologists a group of bacteriologists met and had a discussion about creating a collection of biological materials that the microbiologists could contribute to and draw upon. C.E.A Winslow started that collection at the Museum of Natural History, which eventually became the ATCC. It is now a diverse collection in life sciences that does not consist only of microbes, but also includes cell lines and other biological materials, because we are continually trying to keep up with what is going on in science. We are, along with the Agricultural Research Services Collection (formerly NRRL), one of the first International Depository Authorities (IDAs) officially recognized in 1981 as a depository for materials used in support of life science patent applications. We are also a global distributor with the capability to move materials all over the world. For example, we have a contract with the Centers for Disease Control and Prevention (CDC) to develop an influenza reagent resource and manage it, and part of our service included providing support for the response to the H1N1 virus outbreak when it hit in May of this year. In response we assisted the CDC and the World Health Organization (WHO) in delivering diagnostic kits to laboratories in 133 countries in a very short time period. The WHO noted that this was the fastest response to a global disease outbreak it had ever experienced. ATCC did not develop the kits, however we assisted in their manufacture and assembly, and we distributed them. ATCC is ISO 9001 certified, and ISO Guide 34 and ISO 17025 accredited. ISO Guide 34 establishes the requirements for reference material standards manufacture, and ISO 17025 establishes the requirements for laboratory testing. These accreditations support the activities of ATCC as a material standards provider. We are also accredited by the American National Standards Institute (ANSI) as a Standards Development Organization (SDO). ANSI accredits organizations that develop written consensus 25 Presentation slides available at http://sites.nationalacademies.org/xpedio/idcplg?IdcService=GET_FILE&dDocName=PGA_053677&Rev isionSelectionMethod=Latest. 63

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standards, and we believe that we are the first organization accredited to develop written consensus standards for biological materials. Although there are other organizations engaged in managing biological materials, few of them are developing written standards. We receive no government subsidy for our collections, and all of our financial resources are generated either through the distribution of the cultures and related products, or from other activities in biological materials management. For a time in our history we did receive some subsidies; however ATCC no longer receives any support from the government for any of its collection activities. ATCC started in Chicago, however it has moved to several other locations in its history including three locations in Washington, DC, until a more permanent home was established in Rockville, Maryland in 1964. In 1973 ATCC nearly went out of business, and since I joined in 1974 I was not there at the time, but I have heard many of the details. Financially ATCC was in trouble, the director was fired, and the government stepped in and bailed us out, however noting that the support was temporary and that the organization needed to get its act together. Despite this caution we did continue to get assistance for some of the later programs we developed. With help from a government grant we were able to expand our facilities in 1976, and in the 1980s we began to wrestle with the issue of protecting intellectual property and equitably transferring the biological materials. In 1982 we received some additional government funding in the form of a grant to assist with getting some of our scientific capabilities updated. Data management, particularly with regard to the handling of molecular biology materials, became a critical need at this time. By 1993 our facilities were in bad shape, and we did not have the financial resources to upgrade or relocate. This is typical in a non-profit model where income gets used as it is received; therefore you put your hand out and ask somebody for money. That is when Dr. Cypess arrived at ATCC, and began turning the company around by capitalizing it through better fiscal and operational management, and we eventually ended up with new facilities in Manassas, Virginia. We are now financially very strong and our products and service offerings include not only the traditional cultures, but also derived materials like DNA as well as other related products. We also have a major division that manages government and commercial contracts, generating additional revenue for support of the collections by leveraging our core capabilities in biological materials management. These activities provide much needed infrastructure support, allowing us to pay our bills and enabling the construction of new facilities. There are three areas of operational focus for the ATCC that are of particular interest here. First, we seek to protect our biological assets to ensure their continued availability in support of the advancement of life sciences. As some earlier speakers mentioned, a number of biological collections have disappeared over the years because they lost funding, and I too could offer a number of other examples of where that has occurred. Our goal is to not allow that to happen to the biological materials we have been entrusted with; some of them are over 100 years old. We have an uncompromising commitment to quality, standards, biosafety, biosecurity, and regulatory compliance. We want to make sure things are handled safely, and we want to make sure that we offer the best-quality materials. We also want to ensure standardization for global research activities so that researchers in one location are working with the same material as someone else in another. If the materials they use are different, then their research is not comparable. And, as I noted earlier, we have strains 64

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that have been around since 1925, and because some of these were materials that came to us from the Winslow collection they are actually older than that. We have to ensure that our resources meet changing scientific needs. In particular that means that while we continually add to our collections, we do not however take just anything because doing that would strain us financially. Instead we have to make sure we are adding things that are going to continue to be used as the needs of science change. ATCC has expanded its unique position as a knowledge and technology transfer broker between research and commercial entities. This is not my area of expertise However we have staff at ATCC who deal with this every day, and whose job is to manage the licensing opportunities, the material transfer agreements, and other activities that ensure equitable sharing and use. Our business is managed today in a way that ensures the ATCC enterprise continues in operation and that the biological materials under our care are not lost. Everything we do and every dollar we earn gets plowed back into the organization to ensure that ATCC will be around 100 years from now. In my opinion there are not many government-funded collections that anyone can say will be around 100 years from now, as funding priorities change. Similarly if a private collection is getting funding from an external source, it may not be around in 100 years either for the same reason. Our model for operating the ATCC is focused on ensuring its continued existence and support for scientific advancement. Quality is also important at ATCC and we maintain our cultures as close as possible to the original lines, so when you get an ATCC culture you know it is pretty close to what was put there. A seed stock system was developed at ATCC to ensure that we have low-passage material as close to the original as possible. Since living cells and organisms are perpetuated by replication in culture, genetic changes can occur and it is important to minimize the number of times a culture is sub-cultured. Our brand ensures high-quality standards with low passage numbers, and that is why we do not want others putting the ATCC label on cultures that we have no control over. We did experience problems with that at one time, but we have been able to address that problem and are now in a position to deal with the violators. As some of the microbiologists in the audience are undoubtedly aware, there were companies such as the DIFCO that sold cultures obtained from ATCC that were then used for nefarious purposes, and we would later hear from people that an ATCC culture was used in these instances. While those cultures were not obtained directly from us, the use of our name and trademark implied that we were the supplier. We constantly apply new technologies to our AAPPDD activities, that is, to acquisition, authentication, preservation, production, development, and distribution—all the activities involved in maintaining these materials. We are also continuously updating our operating procedures, and we have a robust quality systems program that manages and monitors our standard operating procedures. Planning for renovation and new facilities is an ongoing process because it is essential as we continue to grow to remain viable. ATCC’s primary focus is standardization, and our goal is to provide standard reference materials to enable scientific continuity and advancement. We are now working with official standards (certified reference materials or CRMs) under our ISO Guide 34 accreditation however we have always focused on providing standards in all of our offerings. If you obtain biological materials from the ATCC today and the same materials again 20 years from now, you can be assured they will be the same. 65

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Recently we developed a proficiency testing standards program which originated out of a need for proficiency testing standards following the H2N2 incident, in which kits were sent out for proficiency testing containing the wrong virus. This was not discovered until an astute diagnostic lab in Canada discovered the mistake, and the CDC alerted us to their concerns and we responded by putting this program in place. It is not a mandatory program and it is purely voluntary; nevertheless a lot of the proficiency testing manufacturers are now coming to us and obtaining reference standards that can be traced back to ATCC to ensure that there are no similar problems in the future. The suppliers that do not participate in this program accept the risk that they may experience a problem in the future. ATCC provides quality control reference standards, some of which are mandated or recommended both in FDA regulations and in the standards put out by such organizations as the Clinical and Laboratory Standards Institute (CLSI). Because we are now an accredited standards development organization, we also develop written consensus standards in support of the material standards we provide. One of the key concepts underlying what we do is termed “added value.” Suppose an organization has some materials that have no value to them, perhaps, for example, a pharmaceutical company has done a study that generated a set of clinical specimens, and the company has no reason to believe the specimens have any further commercial value. While they should consider sharing them with others, their concern is how they can receive some return on their investment in the materials. On mechanism is to offer them through a broker like ATCC that can find new uses for the materials. One thing that should be kept in mind concerning the microbial research commons is that if you do not have a way to support it, it is not going to last. The ATCC is a real example of a national resource that almost disappeared; however, we are not going to let that happen again. Question and Answer Session DR. KURTZMAN: Can you share with us what percent of your income may be derived from the sale of cultures versus other services? DR. SIMIONE: I can give you a high-level answer. The products and services generate about 50 percent of our revenue, and the services area generates the other 50 percent. But within the products and services, I do not know the details of the income breakdown. The cell cultures are probably our biggest seller, and probably about 80 percent of the revenue is derived from the distribution of the cells and microbes. The other 20 percent comes from the sale of culture media, reagents and other items. DR. KURTZMAN: It does. I think it also emphasizes once again that culture collections, except under your situation, are clearly not self-sustaining, and if we expect to have these cultures last for decades in the public domain, something really does need to be done beyond what we are doing now. 66

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PARTICIPANT: Have you given thought to disaster backup? I ask as someone who lived in New Orleans for many years and kept my backup strains at the Department of Agriculture in New Orleans. There was no power in either place after the Katrina hurricane disaster, and we lost them all. DR. SIMIONE: I meant to mention that. We have backed-up our entire collection since 1979, but we had it in various places starting with the government. For a while it was at Fort Dietrick, and then we moved it to a private company. Even those locations were not safe because the government said eventually, “We need the space, take your stuff out.” The private company, while it is still in business, had financial problems and presented a potential risk. We now have our own facility 60 miles west of the ATCC that we maintain with all the bells and whistles—backup generator, everything. We store our collections there in the event we have a physical disaster at the main facility, and we are working on a business continuity disaster plan right now that goes even further to ensure that if we do have a disaster at the main facility, we can continue at least to supply some of the top products . PARTICIPANT: Two questions. One is: At what rate are your collections growing? DR. SIMIONE: Good question. Steve mentioned that they are growing exponentially. Actually, they are not. The areas that the government contracts support— like the MR4, which is the malaria collection—are designed to build collections for specific uses. Those are growing rapidly, however the government is paying for them. The ATCC collections are not growing at the same rate. The main reason is not that we do not have the resources to take on additional materials. We choose very carefully because we do not want to just take a lot of new materials that are not going to be useful, and then just sit in a freezer. It was about 20 years ago we started to hear, “I am not going to give you the material anymore because it might have commercial value. And if I give it to you, you are going to make it available to everybody.” That is when we had to start changing how we operate, and while I do not know how fast they are growing, I do know that they are growing. The cell collection probably now contains about 4,000 lines. PARTICIPANT: The point of the question is not just about the ATCC, but for any collection. There are obviously financial implications as a collection grows that are key to the rate at which it grows. My second question is, are there particular components of the collection that are of greater community interest in terms of accessing them than others? DR. SIMIONE: That is an excellent question, but I cannot get into the specifics because I am not the expert. The problem with providing an answer is that it is a moving target. That is the problem with a public resource like this and I want to emphasize it is public. If we go out of business, these belong to the public; nobody owns them. But, yes, we do pay attention to what is needed over time. We have a marketing group, and while I do not like to call it that; that is what it is, people who look at this issue and ask what is needed by our customers. 67

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So, we are adding materials, but I do not know what the hot stuff is. I know that the cell lines are in great demand, although I do not know which ones. The molecular materials, such as the clones, were hot for a while, and then slowed down. DR. KYRPIDES: A very quick question. It is about the bacteria culture collections from which, if I am not mistaken, number about 15,000 or 20,000. DR. SIMIONE: Yes, I think that number is close. It is 18,000 on the slides. DR. KYRPIDES: For how many cultures do you really know what it is, in the sense that you have genomic sequencing? DR. SIMIONE: I can tell you we do that, but not for the whole 18,000. As with my answer to the previous question, we are going to focus on those that are needed by the scientific community. Now, most of them had been characterized in some way when they came in, but that was prior to the genomic sequencing. We have that capability now, but there is no way we can go back. The issue is the cost; that is it would not be cost effective. DR. KYRPIDES: Half or more than half? DR. SIMIONE: I do not know the answer. I could find out for you though, because somebody at the ATCC knows the answer. 68