Ask BioChain: Understanding the Importance of Biospecimens and Management in Research
In the first installment of this series, we talked about how molecular biomarkers can impact your experimental outcomes. But biomarkers are just one piece of the puzzle; to access those biomarkers, you need to first access high-quality biospecimens, and then understand their importance in the research process. Effective biospecimen management requires knowing which biobanks and repositories have rigorous quality control mechanisms, a strong resource management team, and the range of specimens you need for your latest cutting-edge project.
At BioChain Institute, Inc. our scientists pride themselves on offering our clients a wide range of high-quality biological specimens for use in clinical research. The role of biospecimens in clinical research is complex and multi-faceted. In this second installment of our new series, we’ll walk you through everything you need to know about the importance of biospecimens in research, what makes our biospecimens high quality, and how BioChain sustains that guarantee.
A Biospecimen Overview: The What, Where, and Who
The term biospecimen refers to any sample of biological matter from humans, animals, or plants. Some of the most common biospecimens on the market include tissues, whole blood, plasma, buffy coats, PBMCs, saliva, or urine. Biospecimens can also be more granular, such as DNA, RNA, or protein.
BioChain carries a wide range of biospecimens from a diversity of donors; we specialize in human and animal samples but have a range of plant samples available as well. At BioChain, we understand that accessing diverse samples from different genders, ages, ethnicities, disease stages, and species is important to the generalizability and robustness of clinical research.
Our samples are not only high-quality but also come from a diversity of donor types. We carry specimens categorized according to the continent (e.g. Asian, European, African); ethnicity (e.g. Caucasian, Black); gender (e.g. male, female); age (e.g. fetal, below 90 years); and health (e.g. smokers, and non-smokers, or tumor tissue and healthy tissue). We even have samples from patients with diverse basal metabolic intakes! Our animal samples are equally diverse, with biospecimens available, including monkeys, rats, dogs, mice, pigs, and hamsters. Odds are, whichever sample you need, we will have it.
Biospecimen Procurement
Human biospecimens are procured through reputable hospital biobank vendors. As a company that prides itself on maintaining a large biorepository of high-quality and diversified specimens, BioChain has a network of reliable, transcontinental vendors in Asia, Europe, and North America. All of our vendors are IRB-approved. All of our samples have been consented by the donors and are accompanied by certification that confirms consent and approval. Additionally, we have our internal certification to work with human biological samples.
The best practice for procuring and storing biospecimens is to accompany each specimen with annotations describing the donor of the specimen and their relevant characteristics. For human samples, annotations on biospecimens are considered private patient information and can be sourced from patient self-reporting, lab tests, or clinical trial logs. BioChain’s specimens are always accompanied by the donor’s demographic information, their clinical pathological diagnosis, the date of sample excision, and the date of sample collection. We use sophisticated and comprehensive inventory software to keep track of each and every one of our high-quality samples after they are procured.
Understanding Biospecimens
Biospecimens from human donors can be cellular matter like tissue, urine, or blood, or molecular samples like DNA, RNA, or protein. They are sourced from donor patients through hospitals, clinical trials, or other reputable vendors.
Specimens are not only categorized according to their donor characteristics but also according to the way they’re sampled and stored. These types of specimens include fresh-frozen, snap-frozen, and formalin-fixed paraffin-embedded (FFPE) biospecimens. Each of these categories involves a different process of sample excision, preservation, and storage with its own unique pros and cons. At BioChain, we carry snap-frozen and FFPE biospecimens, with a large vault of archival specimens at our disposal.
The Importance of Biospecimens in Research
Biospecimens are one of the bedrocks of clinical and molecular research. The use of biospecimens has been a cornerstone of the development and growth of fields like genomics, proteomics, transcriptomics, pharmacogenomics, and precision medicine.
Common Clinical Applications of Biospecimens
At BioChain, our biospecimens are used as controls in clinical and molecular research for developing or validating new drugs and therapies, learning how diseases progress or behave, and identifying novel biomarkers. BioChain’s specimens are used across a range of clinical fields, including oncology, pharmacogenomics, and the study of rare genetic disorders. Our biospecimens have a reputation for being some of the highest quality on the market and are used in clinical work such as genomics and proteomics, stem cell research, and, most recently, in furthering the cutting-edge field of spatial multiomics.
High Quality to Save Cost
It’s a widely known fact that clinical research can be costly. Accessing and using high-quality biospecimens ensures that money isn’t wasted on trials that stumble because of unforeseen issues in their controls.
At BioChain, we employ extremely thorough quality control checks at every step of our biospecimen procurement, storage, and shipping process. Not only do we value your time and money, but we are also committed to the success and quality of the research our samples will be used in.
What Makes a Biospecimen “Good”?
Every study has its own needs and specifications. Matching the right biospecimen to the right study needs is important for the accuracy and precision of clinical research.
It’s also important to know that not all biospecimens are created equal. Biospecimen quality is determined by what are called pre-analytic and analytic variables. Pre-analytic variables are things like the physiology of the human donor prior to the sample collection, and collection and handling practices. Analytic factors, on the other hand, are related to the use and handling of the specimen after it’s been procured. These are things like the type of assays used in trials, or the type of analysis done on the biospecimen data after it is collected. The study of how these variables can affect the integrity of biospecimens in research is called biospecimen science.
Effective Biospecimen Management 101
Biospecimens are biological matter; without the right preservation techniques, they have a pretty short shelf life. Sometimes, a sample is needed for research immediately. Other times, it will be years before a specimen is taken out of storage to be used in a study.
Storage Considerations for Different Biospecimens
Different approaches to biospecimen preparation and storage are useful for different study needs and specimen origins. BioChain carries flash-frozen, as well as new and archival FFPE tissue samples from a diversity of human, animal, and plant donors. We have strict and rigorous protocols for the preparation, storage, and shipping of our samples according to the needs of the specimen and our customers.
Formalin-Fixed Paraffin-Embedded (FFPE) Biospecimens
BioChain’s FFPE tissues are tissue samples that have experienced processing for paraffin embedding. After the sample is taken from the donor, a process of paraffinization takes the tissue from an aqueous to an organic state by fixing the sample in formalin immediately after excision. This process readies the biospecimen for long-term storage while still preserving its cellular structure.
FFPE biospecimens can be used to highlight biomarkers in immunohistochemistry (IHC) studies, nucleic acid or protein extraction, and AI modeling work due to their long-term and economical storage abilities. BioChain carries a large inventory of human and animal FFPE tissue dating from the 1990s to the present. FFPE samples are more economical than frozen as they can be stored and shipped at room temperature. BioChain has a large, meticulously organized storage locker with over 500,000 archival FFPE samples available to our customers.
Frozen Biospecimens
BioChain also carries a large inventory of what are called snap- or flash-frozen biospecimens. These are biopsy materials that are immediately frozen in liquid nitrogen and then stored in our industrial freezers at below -80 degrees Celsius. Our frozen biospecimens are useful for in situ hybridization and IHC studies because the freezing process causes minimal damage to the sample’s DNA, RNA, and proteins. In clinical research, they can be used for rapid diagnosis of patient conditions as a frozen biospecimen can be created within moments after a biopsy.
Shipping, Handling, and Quality Control at Every Step
The best practices for biospecimen storage also apply when they’re in transit. Our specimens are sent to us by trustworthy and diversified vendors across the globe. In turn, BioChain ships samples to international customers regularly. Reliable protocols are vital, ensuring that the biospecimens our customers receive are the highest quality possible.
When it comes to our biospecimens, BioChain employs quality control checks at every step of the shipping and handling process. We have an in-house biospecimen resource management team who are responsible for checking the labeling, condition, and storage of our specimens.
Storage and Handling for Inbound Biospecimens
Different storage and packaging techniques are used for different types of inbound samples. Sometimes this is dependent on the type of sample – for example, frozen samples, or liquid samples. Other times, this is dependent on what the biospecimen will be used for – for example, immunohistochemistry versus transcriptomics. Frozen biospecimens need to be kept at -80 degrees Celsius at all times in transport and storage.
Depending on our customers’ study needs, we will order liquid biopsy samples such as whole blood, plasma, saliva, or urine in different types of collection tubes. Some tubes are stable at room temperature, while some tubes are only stable at -80 degrees Celcius. BioChain receives the samples stored in Streck, EDTA, and Paxgene tubes to name a few.
Finally, because BioChain is a GMP 2 facility, our in-house pathologist always conducts rigorous quality control to ensure quality when receiving new biospecimens.
Storage and Handling for Outbound Biospecimens
When our team first receives a sale order from a customer, the production team will prepare the order for shipping. For frozen samples, this means ensuring that the order is packed with dry ice or blue ice to keep it at the appropriate temperature for the duration of its journey. If shipping is expected to take two to three days, our production team makes sure that there is enough ice to last an extra three days in case of delays or issues.
After the order has been prepared, our in-house histopathologist checks that the product has been prepared according to our standard operating practice. This includes checking that the product has been prepared with the correct annotation, quantities, and temperature, as well as ensuring that it is not pathogenic in any way. These quality checks ensure that our customers receive the highest quality products; we know the high resource costs of conducting clinical studies. Our customers can rest easy knowing that a BioChain biospecimen will give them the best possible results.
BioChain tracks its shipped products meticulously to ensure any unanticipated issues that may arise during shipping are immediately addressed without compromising the quality of the biospecimens.
High-quality biospecimens and their effective storage and management are vital to the continued success of your clinical research. Here at BioChain, we have meticulous quality control checks embedded into every point in our process. From the vendors from whom we source our specimens, to our diverse stock, to how we store and ship those specimens to you, we ensure that you have reliable access to some of the best quality biospecimens available.
If you’re interested in using BioChain’s biospecimen samples for your clinical research, feel free to contact us!
