Many biotechnology and pharmaceutical companies depend on commercial intermediates to source clinical samples; however, this may be a disconnected process, preventing the transfer of information on the provenance of biological samples. As a result, scientists have an incomplete picture of the samples they are working with, which raises questions as to whether they are likely to be fit for their intended use.
Technological networks recently had the pleasure of speaking with Robert hewitt, founder and manager of Biological sample center, a unique platform designed to connect biotechnology and pharmaceutical companies with biobanks. Biosample Hub aims to help scientists obtain the samples they need to support testing and the development of new treatments, diagnostics and vaccines, while establishing and maintaining information on the provenance of biological samples. We interviewed Robert to find out more.
Laura Lansdowne (LL): What are biological samples, how are they used and by whom are they used?
Robert Hewitt (RH): Biological samples are biological samples that can come from any human, animal, plant or other living being. In this context, we are talking about human samples. It can be blood, solid tissue, saliva, urine, or any other secretion or excretion. They can be used for diagnosis or if they are in excess of what is needed, they can be used for research.
LL: What is the standard process for providing biological samples to researchers who need them?
HR: The standard process is for a hospital unit called a biobank to take responsibility for the collection, processing and storage of biological samples. These units have staff working to professional standards, who ensure that samples are collected with the informed consent of the patient and are processed and stored under strict standard operating procedures to maintain sample quality and reliability. They issue samples to researchers who have obtained ethical approval for the work for which they wish to use the samples.
LL: What are the main challenges in this process and what role do trading brokers play?
HR: The challenges related to the management of biobanks are numerous. A major challenge is to secure the necessary funds to enable them to function effectively with adequate personnel and equipment. Biobanks are an essential infrastructure for research, but they require ongoing maintenance funding and generally a large portion must come from the host institution where there are many other competing funding needs.
Another major challenge is to connect researchers in need of samples with the appropriate biobank. Researchers have very specific needs, and often finding the right biobank to meet those needs is like looking for a needle in a haystack! This is often not easy to do for researchers associated with academic medical centers and hospitals (public institutions) where samples are usually collected. This is much more difficult for researchers working in biotech and pharmaceutical companies (private institutions) to do, and these researchers need patient samples to test and develop the drugs, diagnostics and vaccines we all depend on.
Trade brokers play an important role in providing samples to scientists in the industry. Their role is to act as an intermediary between the hospitals and biobanks where samples are initially collected, and the industrial customer. While they perform a necessary service, there are some ways that it may not be ideal. In general, brokers avoid putting the sample requester in direct contact with the source of the biobank, as this would risk being bypassed for future requests and therefore loss of income. This lack of direct communication between biobanks and the end user tends to prevent the transfer of information on the provenance of biological samples.
LL: What is provenance in this context and why is it so important?
HR: The word “provenance” means the origin or source of something. In the medical and scientific world when applied to biological samples, it covers the following categories of information:
- Example of treatment history
- Information about the donor and their medical history
- The geographic origin of the samples which provides information on ethnicity and the environment
- Previous organizations that had custody of the samples
The history of sample processing allows the researcher to determine whether the sample is likely to be reliable for the intended research. Many variables affect the quality of the sample – for example, in the case of blood samples that require centrifugation to separate the different components, the quality of the sample can be affected by the type of primary container used, pre-centrifugation time, centrifugation conditions (eg temperature, time and g-force) and more. All of these details must be followed with meticulous attention if the researcher is to be sure that the sample is reliable.
LL: What problems can arise from a lack of provenance?
HR: One example comes from a major program in the United States called The Cancer Genome Atlas (TGCA), for which samples were requested from biobanks across the country for molecular analysis. A very high percentage of samples received were found to be of such poor quality that they were unusable, so provenance information was clearly lacking or unreliable. In 2018, renowned pathologist Carolyn Compton wrote an article in The Pathologist titled “Garbage In, Garbage Out: The Hidden Reason For Lab Test Results May Not Be As Reliable As It SeemsAnd in this article, she emphasized the importance of controlling for preanalytical variables that affect sample quality.
Over the past 10 years, major improvements have been made to biobank standards, with many biobanks in the United States, Europe and around the world striving to improve. Some have introduced quality assurance programs and obtained accreditation and certification to various quality standards. Of course, standards vary from biobank to biobank and this is why it is so important for researchers to know the identity and reputation of the biobank from which their samples come.
Our genes and our environment affect our health, the diseases we contract and also our response to various treatments. It is therefore important for researchers who use biological samples in their studies to have information on demographic factors such as age, sex, ethnicity and geographic origin.
LL: What needs to be done to ensure that biological samples are always accompanied by reliable information on provenance?
HR: The first step is to allow direct communication between the industry researcher and the source biobank. Only then can the researcher begin to have confidence in the provenance information provided. To gain full confidence, the researcher will want to know more about the biobank, whether it has some form of license, certification or accreditation and the standard operating procedures it uses.
In the future, regulatory authorities will undoubtedly have a key role. For example, to access the European market, manufacturers of medical devices including in vitro diagnostics must now demonstrate that the biological samples used to validate their devices have undergone acceptable pre-analytical processing. This is required under the new European IVD Regulation (IVDR) coming into force in May 2022.
LL: What are the alternatives? For example, could researchers build their own supplier networks? Or could an exchange or clearinghouse (as used in financial markets) solve the problem i.e. the clearinghouse knows the details of providers and users and can give users relevant information on a need-to-know basis without revealing the details of the source? Or could researchers be directly linked to sample suppliers via a central database?
HR: An alternative is for industry researchers to obtain samples through a broker that allows direct communication with the source. A few such brokers exist and they avoid circumvention through contractual agreements with their clients / partners. The problem here is that not all companies and biobanks are comfortable with deals that restrict their ability to enter into different partnerships in the future.
To get the samples they need, companies can develop their own biobank networks independently, but this is not a short-term project. They can also access publicly available biobank directories, but these are primarily designed for university researchers.
A recently established nonprofit called Biological sample center provides an additional solution, via an online platform dedicated to the partnership between industry and university biobanks. The platform presents companies with a ready-to-use network of biobanks that all want to work with industry. The platform also includes a business directory, request directory and networking features to enable members to communicate. This is received positively in Western Europe by university biobanks.
Robert Hewitt spoke with Laura Elizabeth Lansdowne, editor-in-chief of Technology Networks.