Biospecimen acquisition is a complex process with ethical, legal, and regulatory considerations (see figure below). Researchers can obtain samples directly from biobanks, hospitals, or clinics, but this approach poses several challenges:
- Many biobanks and collection sites are not well-known to biopharma companies.
- Biobanks and collection sites don’t always have the administrative resources to manage many sponsors simultaneously.
- The client must negotiate ethics and legal documents with each site, requiring time and expertise.
- The client must manage logistics with each site.
As a result, many pharmaceutical companies opt to use commercial biospecimen providers. These entities act as intermediaries between the client and source, facilitating sample acquisition. While convenient, this strategy has potential drawbacks. We’ll discuss the largest risks that biopharma companies face when using commercial biospecimen providers and how best to mitigate them.
Biospecimen acquisition process
1. Biospecimens are not ethically sourced
Specimen providers may use fraudulent documents to hide unethical practices. When vetting a provider, scrutinize relevant documentation, such as approval from the institutional review board, standard operating procedures, and informed consent forms. We’ve encountered providers that have passed off non-authorized copies of documents from other biobanks, collection sites, and clients. If the documents are not written in the local language of the biobank, ask for the originals along with an English translation. A provider that fails to comply is highly suspect and should be avoided. Proper ethics review is critical to protect donor rights and privacy. It also ensures that biospecimens are used appropriately in research that has merit.
2. Biospecimens are duplicates from the same patient
Commercial biospecimen providers can source samples directly from collection sites or go through another provider. In either scenario, but especially the latter, the origin of a sample can be obscured. Say you need to acquire rare specimens, and you contact multiple commercial providers to secure the number needed for your study. The vendors, working independently, may contact the same collection site or rely on overlapping networks of intermediaries to find the samples. The upshot is that you receive duplicates from the same donor, with different patient IDs. If the providers don’t disclose where they obtained the samples, you probably won’t realize the problem. This “double dipping” is a major threat to experimental data. It’s best to seek out providers that can offer full traceability of samples.
3. Biospecimens do not match your study specifications
Many biomarker discovery studies require fit-for-purpose specimens — that is, samples in a particular format from a certain demography with a specific disease at a defined stage. Without clearly communicating these requirements to a biospecimen provider, you may receive the wrong samples. One contributing factor is that criteria for diagnosing diseases can vary from country to country. For example, mantle cell lymphoma is diagnosed using cyclin D1 immunohistochemistry staining in the United States, but this is not the standard method practiced in every country. For breast cancer, at least five sets of guidelines are used globally. If samples are sourced from different geographical regions, you may end up with samples that lack conformity. Another factor is that sample processing, handling, and storage can vary across collection sites. Poor-quality or heterogeneous samples compromise research. By setting expectations early and clearly with a provider, you improve the odds of receiving exactly what you need.
4. Biospecimens lack ethnic or genetic information
Not knowing where your samples come from may lead to false or misleading results. Ethnicity, genetic background, and environment often influence the interpretation of biomarkers. For example, Asian and Caucasian subjects have different immune signatures. If you were to develop a new immunotherapy based on Caucasian immune signatures but unknowingly analyzed samples exclusively from Asian subjects, you would likely draw the wrong conclusions. Biospecimen providers may not be forthcoming about sample origin. We’ve encountered companies headquartered in the US that sell specimens from China without informing customers.
5. Biospecimens are not legally exported
Export permits are required for human specimens in many countries, but this is not widely known in the pharmaceutical industry. Let’s consider the rules in China. Exporting biospecimens is forbidden without permission from the government — a long and onerous process. First, approval must be granted before samples are collected, followed by another lengthy procedure to secure an export permit. We’ve seen many cases where specimens lack both approval from China’s regulatory body and a valid export permit. This poses a risk to the end user, as the samples were not legally collected and exported. Despite claims from sellers, you should perform due diligence to ensure that samples are compliant with country-specific regulations. Ask your provider where samples originated. If they are sourced abroad, request the appropriate documentation and scrutinize it as best possible.
Checklist when sourcing biospecimens
Transparency and traceability of samples are essential for optimal research. Here is a recommended checklist to help you avoid the pitfalls described above:
- Ask your biospecimen provider where the samples have been collected
- Ask to see documentation regarding approvals for sample collection and the informed consent process
- Ask for an official export authorization form for countries that require it
- Ask whether samples have been sold or will be sold to another vendor or broker
When sourcing biospecimens, be proactive and vigilant to ensure you receive samples that are unique, compliant, and fit for purpose. Experienced providers like Azenta Life Sciences offer full transparency and close collaboration, making the process smoother and more trustworthy. Learn how to start planning a sourcing project by watching our workshop, where we covered key topics including, inclusion/exclusion criteria, preanalytical considerations, and regulations for acquiring human biospecimens. Ready to speak with our experts about your sample sourcing needs? Let’s chat! Fill out this form to get started.