Human biospecimens constitute an enormous sector of clinical trial and scientific research. Researchers can study these tissues to look for specific cellular pathologies, biomarkers, and other unique microscopic facets to better understand the processes of disease diagnosis and treatment.
However, how exactly are biospecimens used and how can they be implemented in your own research? Below, we will discuss the top ways human biospecimens are incorporated into research today:
What Are Human Biospecimens?
Human biospecimens are groups of cells, called tissues, that are collected or donated for the purpose of being studied with the intent of further understanding disease and its corresponding treatment.
Biospecimens can be composed of a variety of different tissues, such as solid tumor biopsies, large organ tissue, and even liquid biopsies, or blood or plasma collection. These specimens express their own unique, patient-specific cellular features and biomarkers that will allow researchers and investigators new insight into a disease.
The importance of human biospecimens in research has drastically increased in recent years. With the rise in new technologies, we now have more advanced ways to analyze biospecimens and their corresponding biomarkers quickly and cost-effectively.
Additionally, the rise in genomic medicine has paralleled these advancements, leading to new and exciting opportunities to study the human genome simultaneously to overt, observable biomarkers. Translating a patient’s genotype into their phenotypic makeup has resulted in numerous scientific and medical discoveries.
What Are the Benefits of Human Biospecimens in Research?
Utilizing human biospecimens offers some unique benefits in modern research.
Firstly, human tissues themselves have inherently more specific and translatable characteristics to human clinical trials compared to animal tissues. Certainly, animal model research has tremendous importance when investigating early preclinical drug development parameters, such as pharmacokinetic/pharmacodynamic information as well as early toxicology reports. However, there is no animal model substitute to the specificity of true human biospecimen research.
Additionally, human tissues have become more readily available as a result of biobanking and large biorepositories. These large storage companies allow frozen or preserved biospecimens to be collected in one place, and they are available for researchers in large quantities and at a much greater convenience than a prospective collection effort.
While there are certainly regulatory and ethical considerations regarding the formation of biorepositories as it relates to patient rights and confidentiality, they are an immensely popular option for human biospecimen research efforts.
Finally, as previously mentioned, new technologies allow for a greater understanding of human biospecimens. For example, prior to advancements in microscopic cancer tissue biopsy, cancer patients were evaluated from a whole-patient perspective. While this approach was not incorrect, it lacked the specificity and accuracy of a more personalized, patient-centric treatment approach that tissue biopsy allows us today.
Now, clinicians can evaluate exactly what biomarkers a patient’s tumor expresses and subsequently find a treatment option that has a higher likelihood for treatment success.
What Are Some Common Uses of Biospecimens in Research?
Biospecimen research has a variety of implementations in research today.
One of the most popular uses can be found in the world of oncology. Cancer research nearly depends on the study of human biospecimens, and the majority of new anti-cancer therapies are targeted immuno-chemotherapies that directly act on a biomarker discovered in a cancer biospecimen.
Other uses for biospecimens can be found in genomic medicine. Pharmacogenomics, or the study of how pharmaceuticals are implicated in the human genome, is becoming increasingly popular in medicine today. Genetic information can be isolated from a biospecimen and evaluated for specific genetic mutations that may guide clinicians in choosing the proper therapeutic options.
An example of a commonly sought-after genetic mutation is the EGFR-mutation, frequently found in some solid tumors such as lung cancer. Identifying this mutation may cause a clinician to avoid a drug that has been proven to lack efficacy in the patient population that expresses it.
Finally, one of the most important uses for biospecimens has been established in the drug development industry. This industry encompasses all disease states such as oncology, diabetes, hypertension, and depression. Advancements in modern medicine now allow drug developers the ability to examine the characteristics of biospecimens and retroactively implement rational drug-design.
This targeted drug development approach has numerous benefits to society. Not only does it benefit patients as targeted treatments tend to have better efficacy and safety profiles by design, but their refinement allows a more cost-effective approach to assist in clinical trials.
Biospecimen research directly assists drug development where it most commonly fails – lack of efficacy. Identifying biomarkers and other cellular characteristics during development promotes better drug design as it relates to improved safety and efficacy.
How To Avoid Common Challenges in Using Biospecimens in Research
Despite the existence of large biobanks and biorepositories, obtaining biospecimens is not always easy. There are many challenges to utilizing biospecimens and understanding exactly how to deal with or avoid them in advance can be essential to any research effort.
Regulatory concerns are one of the most frequently encountered hurdles in utilizing human biospecimens in research. The FDA has issued numerous guidances for industry relating to the proper implementation of human biospecimens in research, so understanding these or enlisting the assistance of a clinical research organization (CRO) will be imperative.
Additionally, there are numerous logistical hurdles to biospecimen implementation. Understandably, it can be fairly difficult to balance scientific accuracy with practicality and efficiency when it comes to obtaining biospecimens. Sometimes these processes take weeks or months, depending on the type of biospecimen that is desired. More specific specimens such as tissues obtained from donors with rare diseases can take a very long time to amass.
There are logistical concerns with patient-specific donation as well. Beyond the crucial informed consent and confidentiality aspects of biospecimen donation, it takes time for a pathologist to examine the tissue. Beyond this, it takes additional time for proper preservation, storage, and shipment to the biospecimen’s final storage location.
Biospecimen storage can be another substantial challenge. The vast majority of biospecimens are not immediately utilized post-collection for diagnosis or treatment. Instead, most donated specimens are secured from post-surgical procedures and then stored in specialized biorepositories. These repositories have specific usage and regulation requirements which must be understood prior to accessing them.
Some, like the Cooperative Human Tissue Network (CHTN), are more specialized in their approach to biospecimens and can provide tissues upon investigator request. However, most repositories are large tissue banks such as the National Cancer Institute (NCI) Clinical Cooperative Group Banks utilized for cancer research.
For these reasons, it can be beneficial to partner with industry leaders in biospecimen obtainment and research. Tailoring biospecimen requests either retrospectively or prospectively and whether or not to use a public or private biorepository often precludes the assistance of industry experts in the field of biospecimens.
What To Look for in a Human Biospecimen Tissue Provider
Choosing the right biospecimen tissue provider can make all the difference in a research effort. Trying to obtain the right biospecimens to fulfill the research needs while balancing cost and efficiency can be an exhausting effort. CROs can be invaluable at this stage and can assist with networking different biospecimen providers globally to find the right specimens for any specific research needs.
Company profile will be one of the largest considerations when choosing a biospecimen provider. There are advantages and disadvantages to utilizing larger specimen providers, such as easier and more comprehensive access to a variety of biospecimens. Oftentimes, these specimens come at a decreased cost. However, for more niche specimens, sometimes it can be beneficial to work with smaller operations that can provide specialty services that work with you more directly.
In addition to company profile, you will want to select a provider that prioritizes quality of the samples from initial acquisition to final storage after preservation. Depending on the sample, there are numerous ways to prepare a specimen such as freezing, formalin-fixture, and phosphate-buffered saline (PBS). Ensuring the biospecimen is preserved correctly and then stored in a quality-controlled environment is essential.
One final consideration for finding the right biospecimen provider is shipping and logistics. Shipping method, speed, and international shipping regulations are all major concerns when it comes to finding a quality provider. Multiple distribution locations can be a huge advantage to making sure a shipment can arrive quickly and affordably due to close proximity and access to donor tissue samples from multiple patient demographics geographically.
Why Choose iProcess as Your Human Biospecimen Tissue Provider
At iProcess Global Research, you can expect to work with a well-connected, networked, and experienced team of researchers who can work with any research needs to supply even the most specific biospecimens.
Not only will you receive an individualized approach to your research, but you can be comfortable with the fact that iProcess is a global supplier of biospecimens with over 100,000 samples shipped.
Extensive industry experience coupled with regulatory expertise allows iProcess to maintain a global network of over 1,000 sites internationally. With access to both biobanked and prospective tissue samples, you can contact iProcess and obtain a quote today.