With the completion of the Human Genome Project in 2003, basic life scientists and clinical researchers have developed alternative techniques for gene identification and analysis. Biomarker research has led to unparalleled discoveries, as investigators have isolated genotypic characteristics that correlate with morbidities.
Biospecimens constitute a large portion of this research sector and are a driving force for therapeutic advancements in molecular medicine. As long as relevant samples are available in flexible formats for a series of assays, biomarker discovery is set to continue making progress.
However, sourcing high-quality biospecimens for clinical research can be challenging and time-consuming. This is why it’s important to identify a single-source biospecimen solutions provider that can support you through all aspects of your project lifecycle.
What Is a Biospecimen?
Biospecimens are biological samples of material from the human body. They have served an integral role in the practice of medicine, defining patients’ pathobiology to determine a diagnosis.
Now, they play a more treatment-centric role, linking the biology of disease and the biology of patients to target individualized therapies.
Some research is best undertaken using biological fluids that can be excreted, secreted, or aspirated. These samples can come fresh or frozen, with or without additives.
Biofluids used in research can include:
- Whole blood
- Plasma, serum, buffy coat
- Cerebrospinal fluid
Tissues are groups or layers of cells that coordinate a specific biological function. These samples can come fresh, frozen, or fixed from diseased or healthy individuals. The highest quality tissue samples will be characterized on the molecular and genetic levels.
Biological tissues can include:
- Tumor biopsies
Viable Cells, DNA, RNA, and Protein
In some cases, research can be better conducted with small-scale specimens such as individual cells, DNA, RNA, or individual proteins.
These can include:
- Extracted DNA/RNA
- Peripheral blood mononuclear cells (PBMC)
- Bone marrow mononuclear cells (BMMC)
- Immune cell subsets
How Are Biospecimens Obtained?
Biospecimens can be collected or donated, generally following a diagnostic test or procedure. These biological samples are also annotated with associated health information and patient demographics.
Safeguards are put in place to protect the subject’s rights and safety in accordance with signed informed consent and protective practices. Legal and ethical considerations take priority in the collection, storage, use, sharing, and disposal of human biospecimens. Remember, these samples are a non-manufactured, non-renewable resource.
How Are Biospecimens Stored?
Samples must be handled, labeled, and stored in accordance with regulatory standards. Collections of biospecimens are housed, or “banked”, in a biorepository, each one richly annotated with all clinical and molecular characteristics.
A biorepository, or biobank, is any entity that receives, stores, processes, or disseminates biological specimens. These can range from free-standing local labs to larger multinational collection networks.
There are two major types of human biobanks: population-based and disease-oriented. Population-based biobanks sample the general population to study certain diseases and demographics, while disease-oriented biobanks sample diseased- individuals to study a specific disease state against control samples. Both types can vary in organizational structure.
Biobanking allows for the long-term storage of these biological specimens. Unique identifiers are assigned to each sample to help with tracking across a state-of-the-art lab inventory management system.
As long as storage requirements are met, quality can be assured at the time of retrieval.
What Benefits Do Biospecimens Provide to Clinical Research?
As we move from stratified medicine to precision medicine and precision public health, we have seen the value of using genomics for individualized, target-based therapies and population-based interventions.
There has been unprecedented growth in molecular medicine, with new discoveries identifying genotypic factors that translate to phenotypic risk for disease or response to treatment. Much of this progress has been made through clinical research via biospecimen analysis, making biological specimens an essential component of these medical advancements.
Precision medicine can give us a more foundational understanding of the underlying mechanisms by which diseases can occur, help to improve diagnostics and treatment options, and result in some newly classified disease states.
But as the industry evolves in a shifting economy, it’s important to consider the financial implications of accelerating research while simultaneously improving outcomes. Study costs can vary greatly depending on the type of biospecimens involved and whether they are collected proactively or provided retroactively from a biobank.
Plus, associated costs from technologies included in the analysis and the advancements of such technologies can rise depending on certain factors. Cost efficiency can be increased when specimens are readily available and easily retrievable.
How Can You Source a Biospecimen?
One of the biggest challenges facing biospecimen procurement is the diffuse landscape in which samples are collected and biorepositories are formed. From single-study clinical research to larger, hospital-based biobanks, the lack of standardization among biospecimens can lead to the underutilization of samples.
As strategic players in translational medicine, it is important for investigators to have open communication about their study protocol and required biospecimens. Inform your biospecimen solutions provider what you are using your samples for.
This information can allow them to accurately match and deliver upon your study requirements.
You can adjust your biospecimens by the following factors:
- Purchase price
- Depth of data
How To Choose the Right Biospecimen Solutions Provider
From design to execution of biomarker-informed research, you want a biospecimen solutions provider that partners in changing patient outcomes.
Here are the top factors to consider in a potential biobank.
Look for an Expanding Collection Network
A reputable biobank features a continuously growing collection of biological specimens with global reach.
You should look for:
- Access to samples across various institutions
- Validated and certified shipping systems
- Import and export permit coordination
- Compliant shipping procedure
The biobank you choose will be a partner in research. Therefore, make sure that the facility boasts reputable practices.
These can include:
- Sample-specific storage standards
- Backup with off-site redundancy
- Authorized security
Extensive Biospecimen Selection
Look for a selection of high-quality specimens that match the protocol, regardless of the disease state.
- A wide range of clinical sites
- Complete sample management
- Single-system annotation
When you receive your specimens, you want to make sure that they are immediately ready for research use. Look for streamlined ordering practices and rapid specimen retrieval.
To abide by ethics and ensure the highest quality research findings, make sure your biospecimen provider is familiar with and compliant with relevant regulations and practices.
You should look for:
- Storage with Current Good Manufacturing Practices (CGMP)
- College of American Pathologists (CAP) accreditation
- ISO certification.
With all the complexities surrounding clinical research, biospecimen procurement should not be one of them. All it takes is identifying a provider working toward a partnership rather than a transaction.
High-Quality Biospecimens – Superior Science
Biospecimens are the basis of the molecular characterization of disease as well as the molecular characterization of the host, prospectively defining disease susceptibility and treatment efficacy. However, specimens are exposed to a variety of factors that may weaken their molecular integrity, which can result in inaccurate data and reduced outcomes.
Specimen quality can directly impact our ability to support patients in real time and produce statistically significant data.
Standardization of specimens for specific disease states can drive the development of precision therapies. Staying cognizant of all potential pre-acquisition and post-acquisition variables affecting the composition and consistency of your biospecimens and communicating any concerns with the provider will enhance quality standards.
Pre-acquisition variables can include:
- Pre-existing medical conditions
- Drug use (prescription, over-the-counter, recreational)
- Type and duration of anesthesia
- Intraoperative blood loss
Post-Acquisition variables can include:
- Time at room temperature
- Temperature of room
- Extraction method
- Type and time in fixative
- Storage temperature and duration
Removing any barriers to the highest-quality, protocol-specific specimens can help promote timely advancements. Positive patient outcomes and interventions in precision medicine are not possible without reproducible data, and accurate data is not possible without high quality specimens.
Unlocking Your Research Potential
As we bridge translational and precision medicine, both for the individual and for the population, we can leverage cellular and molecular phenomena for the development of novel therapies and technologies. Biospecimen procurement is at the core of this research as we work collectively to build and increase the value of existing sample collections.
Explore more information related to the use of biospecimens in clinical trials.
iProcess: Bringing Research From Bench to Bedside
As a global leader in biospecimen procurement, iProcess works with numerous institutions to deliver high-quality biological specimens for even the most complex projects.
With over 17 years of experience and a global network of over 1,000 sites, iProcess is a trusted biospecimen supplier to top pharmaceutical, life science, and biotech companies around the world.
The Human Genome Project | National Human Genome Research Institute