This research involves collecting biospecimens from 7,000 birthing parents and their children to investigate how prenatal and postnatal experiences influence children’s neural, cognitive, behavioral, social, emotional, and health outcomes.

The Impact of Early Experiences and Exposures on Infant Health Outcomes

The development of the human nervous system is a complex process, beginning a few weeks after conception and continuing throughout gestation and long after birth. This development is driven by a complex interplay of genetic and environmental factors, with the late prenatal stage and early infancy marking a period of exceptionally rapid and significant change. Although it is well understood that these factors impact childhood development across biological and social domains, the precise causal relationships between early exposures and subsequent behavior remain unclear. Therefore, gathering diverse data from birthing parents and their children during both prenatal and postnatal stages is essential for uncovering the biological mechanisms that link early-life exposures to developmental outcomes.

In this manuscript, the research team presents the rationale behind the study, detailing the selection of specific biospecimen collections (e.g., blood, saliva, nails) and other tests conducted at various developmental stages (i.e., prenatal, 0–1 month, 3–9 months, 9–15 months). The study design aims to balance the depth of phenotypic information collected with considerations of participant burden and other relevant factors.

EL Sullivan, R Bogdan, L Bakhireva, et al., Biospecimens in the HEALthy Brain and Child Development (HBCD) Study: Rationale and protocol, Developmental Cognitive Neuroscience, Volume 70, 2024, 101451, ISSN 1878-9293. https://doi.org/10.1016/j.dcn.2024.101451.

Cohort Selection

The HBCD study was designed to consider population diversity and specific substance exposures. Accurate representation of the broader population is essential to minimize bias in large cohort studies. At the same time, a key goal of the study is to examine infant exposure to substances such as opioids, marijuana, alcohol, tobacco, and others. To achieve both aims, the researchers organized the cohort into three categories.

1. 50% – Racially, ethnically, and socioeconomically diverse cohort representative of the U.S. population
2. 25% – Pregnant persons with use of targeted substances
3. 25% – Individuals demographically and behaviorally similar to group two but without substance use during pregnancy

All participating birthing parents are between 18 and 50 years of age and will have given birth 12 months before the start of the study.

Parameter Selection

Data is collected from biospecimen analysis (i.e., genomics/epigenomics), questionnaires, interviews, biosensors, behavioral, electroencephalogram (EEG), and magnetic resonance imaging (MRI). This enables researchers to link prenatal and postnatal experiences, including:

• Physical health
• Behavior
• Neurocognition/language capabilities
• Neurodevelopment
• Activity and sleep

Biospecimen collection is a central component of the HBCD study, providing researchers with objective insights into various biological mechanisms and exposure to specific target substances. The types of biospecimens to be collected and the rationale for their collection include:

• Blood: To assess biomarkers and environmental exposures in the birthing parent
• Urine: To assess proteins and environmental exposures
• Nails: To index substance exposure
• Saliva: For genetic material and to track epigenetic changes over time
• Stool: To facilitate microbiome studies in child participants

Sampled, a CAP-accredited and CLIA-licensed analytical laboratory and biorepository, performs the ongoing specimen collection logistics, sample storage, and analytical processing.

Implications for Research

The HBCD study aims to generate a comprehensive collection of high-quality biospecimens and associated data for future use by diverse research teams. In addition to providing these resources, the researchers offer guidance on effectively applying the data to various fields, including genomics, nutrition, toxicology, inflammation, microbiome, and metabolomics. The depth and robustness of this data will support a wide range of research areas and help address longstanding questions about how early experiences and exposures influence neurocognitive and behavioral development.

“The design of the HBCD study, pairing the longitudinal collection of extensive phenotypic data with varied biospecimens, will enable researchers to interrogate the complex relationships in child development between genetics, environment and maternal drug exposure using state-of-the-art multiomics approaches including bulk and single cell next generation sequencing, epigenomics, metagenomics, and metabolomics.“

Michael Sheldon, PhD

Dr. Sheldon has a career spanning more than 30 years in genetic research and biobanking. In 2021, he founded the Scientific Affairs department at Sampled with the mission to provide expert technical resources to clients, discovery and adoption of new technologies, and the coordination of outreach initiatives. Prior to that he served as Senior Director of Sample Processing Services at RUCDR Infinite Biologics (now Sampled), with oversight of all sample processing services relating to blood fractionation, cell and stem cell culture, and nucleic acid extraction.

Dr. Sheldon received his B.A. from Cornell University in 1983 and a Ph.D. from SUNY at Stony Brook in 1993. He is an Adjunct Professor of Genetics at Rutgers University and is a published researcher in Genetics, Neurodevelopment, and Stem Cell biology.

Safe and scalable product storage is essential for pharmaceutical and medtech companies to consistently meet market demand. However, building and maintaining large storage facilities for drugs, biologics, medical devices, and therapeutic products can drive up operational costs. Many products, such as flu vaccines, are only needed seasonally, leading to underused storage space and unnecessary expenditure. This makes outsourcing a cost-effective alternative to reduce CapEx. However, finding a reliable, WDA-licensed partner with the capacity to manage and store large volumes of inventory can be a significant hurdle.

WDA licensing, regulated by the MHRA, is mandatory for any organisation that stores or distributes human or veterinary medicines in the UK. This license ensures compliance with strict regulations, requiring that medicinal products are handled safely and maintained to high quality standards. WDA ensures customer protection by safeguarding end users from counterfeit products. It also mandates thorough documentation, which must be accurately maintained and stored for a minimum of ten years.

By obtaining WDA licensing, Sampled now offers a powerful new service covering distribution, returns, recalls, and secure long-term storage of medicinal products in two specialised warehouses (Cold 2–8 °C and Controlled Ambient 15–25 °C). This solution is ideal for large pharmaceutical manufacturers and is capable of handling substantial volumes while offering flexibility and reliability. Located on Scotland’s central M8 corridor, Sampled streamlines logistics across the UK and beyond, with key advantages for pharmaceutical and life science companies, including:

• Eliminating CapEx and maintenance costs for new storage facilities
• Scaling with demand so you only pay for what you need
• Remaining up to date with technological advancements and regulatory requirements to ensure enduring quality and compliance

“I am delighted to announce that Sampled has obtained WDA licensing, allowing us to offer extensive outsourced storage and distribution services for pharmaceutical companies operating within the UK. This marks a significant expansion of our storage and logistics offerings, further strengthening our support for life sciences organisations with flexible, compliant, and scalable solutions.”

Mike Whatmough

General Manager UK, Europe & Global Technical Services, Sampled

About Sampled

Sampled is a fully integrated laboratory and biorepository with industry-leading storage, sample management, multiomics, cellular services, and custom clinical kitting. Founded in 1999 as RUCDR at Rutgers University, Sampled operates facilities in the US and UK and is CAP accredited and CLIA licensed. Sampled is committed to providing the highest quality sample storage, processing, and analysis services that enable researchers to make new discoveries and advance human health. When combined with state-of-the-art biobanking facilities, these capabilities provide comprehensive scientific solutions that speed time to quality data.

Media Contact

Caroline Mitchell, PhD

Director, Content & Creative Strategy, Sampled

communications@sampled.com

Piscataway, NJ – Sampled, an integrated analytical laboratory and biorepository, has partnered with the European Bank for Induced Pluripotent Stem Cells (EBiSC) as the sole distributor of their stem cell line catalog to US researchers.

Induced pluripotent stem cells (iPSCs) are the bedrock of many modern research applications. Researchers use them to generate precise disease models for basic research and more precise drug screening applications. iPSC-based therapies are already showing promise in clinical trials for diseases spanning oncology, ophthalmology, hematology/immunology, and neurology. iPSCs are an enduring asset for scientific research, growing in relevance as new technologies and infrastructures facilitate their implementation.

EBiSC is a centralized biobank that maintains iPSCs and their associated data for use by both non-profit and commercial organizations. They currently store over 900 cell lines representing more than 40 diseases and address common challenges facing iPSC researchers by maintaining important GDPR regulatory and legal information. EBiSC performs functional and phenotypic characterization of derived cell lines, which helps to streamline research efforts and reduces the experimental burden on research teams. A highlight of the repository is the EBiSC-NEUR1 iPSC neurons, a doxycycline-inducible cell model that allows researchers to study diverse neuronal lineages. The EBiSC catalog, available at www.EBiSC.org, provides a comprehensive list of available cell lines and associated data.

Sampled has partnered with EBiSC as the sole distributor of their iPSC catalog to US researchers, including EBiSC-NEUR1 iPSC neurons, to support diverse applications across broad therapeutic areas. This partnership improves accessibility to important cell lines and builds on the existing cell line catalogs that Sampled distributes for organizations such as the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH) Stem Cell Center.

Sampled offers a suite of iPSC services, including iPSC reprogramming from fibroblasts and lymphocytes, gene editing, expansion, storage, and quality control. Comprehensive multiomics offerings enable on-site analysis of iPSC lines, spanning genomics, transcriptomics, proteomics, and more.

“I am thrilled to announce the partnership between Sampled and EBiSC to make their valuable iPSC collection available to investigators in the US. We consider this an important and essential addition the stem cell line repository offerings Sampled already provides.”

Mike Sheldon, PhD

Senior Director Scientific Affairs, Sampled

About Sampled

Sampled is a fully integrated laboratory and biorepository with industry-leading storage, sample management, multiomics, cellular services, and custom clinical kitting. Founded in 1999 as RUCDR at Rutgers University, Sampled operates facilities in the US and UK and is CAP accredited and CLIA licensed. Sampled is committed to providing the highest quality sample storage, processing, and analysis services that enable researchers to make new discoveries and advance human health. When combined with state-of-the-art biobanking facilities, these capabilities provide comprehensive scientific solutions that speed time to quality data.

Media Contact

Caroline Mitchell, PhD

Director, Content & Creative Strategy, Sampled

communications@sampled.com

Piscataway, NJ – Sampled, an integrated analytical biorepository and multiomics company, is proud to announce its selection as a Genomic Characterization Center for the Genome Characterization program of the National Cancer Institute (NCI), part of the National Institutes of Health. This prestigious Indefinite Delivery, Indefinite Quantity (IDIQ) contract has a funding ceiling of $150 million, positioning Sampled as a key contributor to supporting the advancement of cutting-edge cancer research and genomic discovery.

Under the award, Sampled will participate in all four contract pools, leveraging its state-of-the-art technologies and expertise to deliver comprehensive genomic solutions:

Pool 1 – DNA Sequencing

Whole Genome Sequencing and Whole Exome Sequencing using DNA extracted from FFPE or fresh frozen samples to support researchers comprehensive understanding of cancer biology by identifying mutations, structural variations, and genetic abnormalities that drive tumor progression critical for advancing precision oncology, uncovering novel therapeutic targets, and supporting large-scale cancer genomic studies.

Pool 2 – RNA Sequencing

RNAseq and microRNAseq using RNA extracted from FFPE or fresh frozen samples for transcriptomic analysis which will support researchers to analyze gene expression and regulatory pathways, revealing how genetic changes affect tumor development and behavior, essential for to identify biomarkers, study tumor microenvironment interactions, and potentially monitor responses to cancer therapies.

Pool 3 – Epigenome Characterization

Methylation and Chromatin Accessibility Characterization with array and sequencing based assays using DNA extracted from FFPE or fresh frozen samples to support NCI researchers to investigate critical changes, such as methylation patterns and chromatin remodeling, that drive cancer progression and therapeutic resistance.

Pool 4 – Single Cell/Spatial Characterization

Single-cell RNA, ATAC-seq, Spatial, and In Situ Analyses from FFPE or fresh frozen samples allowing a detailed understanding of tumor heterogeneity and the tumor microenvironment by analyzing individual cells and their interactions, for studying treatment resistance, advancing immunotherapy, and personalizing cancer care.

“Being part of the NCI Genome Characterization contract is a testament to Sampled’s unwavering commitment to delivering innovative and reliable solutions for cancer research,” said Greg Morrissey, Sr Director Government / Public Sector at Sampled. “Our participation across all four contract pools underscores our diverse capabilities in supporting the scientific community to uncover the complexities of cancer and drive precision medicine forward.”

“Sampled’s selection for this contract is an significant milestone in our mission to support cancer researchers with cutting-edge multiomics tools,” said Shareef Nahas, Chief Scientific Officer of Sampled. “Our team is deeply committed to advancing human health and medicine. This partnership with the NCI allows us to contribute directly to advancing oncology research, accelerating the discovery of novel cancer therapies, and improving patient outcomes through comprehensive genomic and molecular insights.”  

As a trusted partner to the NCI and the broader research community, Sampled’s contributions will enable groundbreaking discoveries in cancer genomics and epigenetics. The company’s integrated approach, combining cutting-edge technologies, robust infrastructure, and unparalleled expertise, ensures that researchers have access to the highest quality data and insights.

View the Press Release at PR Newswire Here

About Sampled

Sampled is a fully integrated laboratory and biorepository with industry-leading storage, sample management, multiomics, cellular services, and custom clinical kitting. Founded in 1999 as RUCDR at Rutgers University, Sampled operates facilities in the US and UK and is CAP accredited and CLIA licensed. Sampled is committed to providing the highest quality sample storage, processing, and analysis services that enable researchers to make new discoveries and advance human health. When combined with state-of-the-art biobanking facilities, these capabilities provide comprehensive scientific solutions that speed time to quality data.

Media Contact

Caroline Mitchell

Director, Content & Creative Strategy

communications@sampled.com

However, maintaining adequate -80°C freezer infrastructure is technically and economically demanding. Many research institutions have storage facilities that fail to meet their needs and lack the flexibility required to support the dynamic demands of scientific research. The risks and costs of maintaining these facilities make outsourcing storage an attractive option for small and large laboratories. Sampled offers robust and secure -80°C storage facilities that respond to clients’ specific needs and give them peace of mind for the long-term storage of precious samples.

This article will explore the critical role of -80°C freezers in modern research, examining their importance in preserving biological samples, the financial considerations involved, and the potential risks of inadequate freezer infrastructure. Additionally, we’ll discuss how Sampled offers a comprehensive solution to these challenges, ensuring sample integrity and enhancing research efficiency.

The Role of -80°C Freezers in Modern Research

Many of the most critical samples and reagents for biomedical research require storage at -80°C. This includes cell lines, biologics, drug compounds, and essential biomolecules like DNA, RNA, and protein^1–3. Robust storage of reagents and samples is crucial to research success, particularly for longitudinal studies where temperature-sensitive samples must be stored for decades. Academic labs, startups, and large life science companies need secure storage for sensitive samples and intellectual property like newly developed cell lines and innovative therapies.

Cost Considerations of -80°C Freezer Facilities

-80°C freezer infrastructure is costly to install and maintain. Modern -80°C freezers can cost over $10,000, depending on their size, and consume a significant amount of energy depending on different characteristics like age⁴. As a result, laboratory budgets are highly sensitive to changes in fluctuating energy prices and geopolitical instability. Furthermore, -80°C freezers require regular maintenance by trained personnel. In smaller research laboratories, responsibility for -80°C freezer maintenance often falls to research staff, which means highly-trained personnel spend too much time on freezer upkeep and less time performing experiments and driving innovation. Laboratory managers may look to sidestep these costs by opting for hand-me-down -80°C freezers from other laboratories or neglecting freezer maintenance altogether. However, these “solutions” pose severe risks, endangering sample integrity and jeopardizing entire research projects.

Risks of Inadequate -80°C Freezer Storage

Inadequate -80°C freezer infrastructure not only risks sample degradation but also exposes laboratories to regulatory violations and potential health hazards for their staff⁵. -80°C freezers introduce several risks into laboratories, including slipping, freezing, and tripping hazards. The latter is particularly salient in institutes lacking a dedicated freezer room, where bulky -80°C freezers must be stored alongside sensitive lab equipment in high-traffic areas.

As cell lines, biologics, and other therapies requiring -80°C storage become more prevalent, regulatory requirements for -80°C infrastructure are expected to become more stringent and comprehensive. Thus, in addition to having robust systems that ensure freezers remain at the appropriate temperature, researchers will require more detailed documentation that proves samples and therapies have been properly stored.

Sampled’s -80°C Storage Infrastructure

At Sampled, we maintain 600 mechanical -80°C freezers, with the capacity to support up to 1,000 individual freezers, all aligned with International Society for Biological and Environmental Repositories (ISBER) standards⁶. We maintain a rigorous security system for our -80°C freezer infrastructure, including individual alarms for each freezer and real-time monitoring so we always know what is happening with our clients’ samples. Furthermore, our entire storage facility can be run from a single generator, and we have four backup generators to ensure our clients’ samples are always stored appropriately.

We also provide a disaster recovery service, where our team will retrieve your temperature-sensitive samples or entire -80°C freezer setup and transfer them to our facility for secure storage. Sampled’s storage solutions offer a cost-effective, risk-free way to securely store even the most valuable samples and have earned the trust of government bodies and private sector corporations alike.

Conclusion

Maintaining optimal -80°C freezer storage is crucial yet challenging for research institutions. With high costs and operational risks, many labs struggle to preserve sample integrity in the long term. Sampled addresses these challenges with a reliable and secure storage solution, offering comprehensive infrastructure and monitoring aligned with rigorous international standards. Our services not only mitigate the risks and costs of in-house freezer management but also ensure peace of mind for researchers, safeguarding valuable samples essential for advancing scientific projects.

References

1. Comstock GW, Burke AE, Norkus EP, Gordon GB, Hoffman SC, Helzlsouer KJ. Effects of Repeated Freeze-Thaw Cycles on Concentrations of Cholesterol, Micronutrients, and Hormones in Human Plasma and Serum. Am J Epidemiol. 2008;168(7):827-830. doi:10.1093/aje/kwn327

2. Kellman BP, Baghdassarian HM, Pramparo T, et al. Multiple freeze-thaw cycles lead to a loss of consistency in poly(A)-enriched RNA sequencing. BMC Genomics. 2021;22(1):69. doi:10.1186/s12864-021-07381-z

3. Shao W, Khin S, Kopp WC. Characterization of Effect of Repeated Freeze and Thaw Cycles on Stability of Genomic DNA Using Pulsed Field Gel Electrophoresis. Biopreservation Biobanking. 2012;10(1):4-11. doi:10.1089/bio.2011.0016

4. Gumapas LAM, Simons G. Factors affecting the performance, energy consumption, and carbon footprint for ultra low temperature freezers: case study at the National Institutes of Health. WRSTSD. 2013;10(1/2/3):129. doi:10.1504/WRSTSD.2013.050786

5. Laboratory NRC (US) C on PP in the. Working with Laboratory Equipment. In: Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards: Updated Version. National Academies Press (US); 2011. Accessed October 11, 2024. https://www.ncbi.nlm.nih.gov/books/NBK55884/

6. ISBER. Accessed October 28, 2024. https://isber.org

By providing access to a diverse collection of high-quality patient-derived cell lines, NINDS facilitates breakthroughs in understanding diseases like Alzheimer’s and amyotrophic lateral sclerosis (ALS).

Partnering with SAMPLED for secure storage and efficient distribution, NINDS supports researchers worldwide in developing novel treatments and expanding knowledge in the field. This blog explores the impact of the NINDS Biorepository on cellular research and the crucial role of advanced biobanking practices, such as those implemented by SAMPLED, in preserving the integrity of these essential resources.

The National Institute of Neurological Disorders and Stroke

NINDS supports furthering our understanding of neurological disorders through education, funding, and its biorepository¹. The NINDS biorepository maintains a diverse set of patient-derived cell lines, including induced pluripotent stem cells (iPSCs) and fibroblasts for many neurological disorders such as Alzheimer’s disease. By providing high-quality cell lines for research and clinical trials, NINDS enables researchers to derive crucial information about neurological disorders and promotes the generation of novel therapies and management strategies. NINDS relies on SAMPLED as a trusted partner to securely store and distribute cells.

Sample Storage Challenges in Modern Research

Research institutions face several challenges when storing samples and reagents. Small institutions can struggle with capacity and having sufficiently skilled staff to manage storage infrastructure and data security, while large institutions can struggle with adapting their existing infrastructure to evolving research environments. For instance, personalized medicine and the discovery of biomarkers for neurological diseases from diverse tissue types mean that more samples may need to be stored for individual patients^2–4.

The high volume of samples necessitates more automated approaches to sample security. Manual monitoring becomes increasingly inefficient and unreliable as the volume of samples increases. Institutions like NINDS possess highly valuable cell lines sensitive to temperature fluctuations. Thus, they have an increased need for robust systems to ensure sample integrity. Beyond physical security, biorepositories require robust cybersecurity measures to safeguard patient data. In addition to protecting data, it is essential that samples and their related information are well-organized and readily accessible to authorized personnel.

Benefits of Advanced Biobanking

Advanced biobanking systems, such as those employed by SAMPLED in its partnership with NINDS, help to overcome many of these challenges, offering enhanced sample quality and security to bolster research efforts.

Scalability

Flexible storage capacity is essential for optimal biobanking and allows researchers to tackle more ambitious research projects incorporating more patient samples, treatments, and timepoints.

Security

Modern biobanks incorporate robust physical and data security systems to ensure patient data and samples are handled appropriately and are less vulnerable to theft or loss due to disasters. These systems include data encryption, dedicated alarm systems, real-time monitoring, and adherence to international regulatory standards such as the International Society for Biological and Environmental Repositories (ISBER)⁵ and the Health Insurance Portability and Accountability Act (HIPAA)⁶.

Automation

Modern biobanks use automation to streamline the retrieval and processing of different samples. This helps to eliminate the chances of human error, which can accelerate sample degradation and lead to sample misplacement.

The SAMPLED Framework

SAMPLED is the dedicated supplier for the NINDS Human Cell and Data Repository (NHCDR) and is trusted by other government institutions for sample storage and distribution. SAMPLED maintains a modern sample collection, storage and analysis infrastructure to help streamline the next generation of therapies for neurological disorders.

Automation

SAMPLED uses high-end automated instrumentation throughout its sample collection and storage pipeline. This helps ensure samples are stored at optimal temperatures, giving the best chances for high-quality data.

Security

SAMPLED uses dedicated alarm systems and real-time monitoring for each of its 600 mechanical -80°C freezers to ensure samples are always maintained appropriately. SampledSphere is our Title 21 CFR part 11⁷ and HIPAA-compliant cloud-based portal where clients can view their data and receive reporting tailored to their needs.

Ordering NINDS Cell Lines

SAMPLED facilitates efficient ordering of cell lines from NINDS to drive the next generation of treatments for neurological disorders.

Visit this page for a detailed guide.

Conclusion

The NINDS Biorepository, bolstered by its partnership with SAMPLED, is transforming cellular research by providing researchers with secure, high-quality, patient-derived cell lines. This resource accelerates breakthroughs in understanding neurological disorders and developing novel therapies.

With advanced biobanking practices, including automated storage, robust data security, and scalable infrastructure, NINDS ensures the preservation and accessibility of critical research materials. As a result, the biorepository plays a pivotal role in advancing scientific knowledge and treatment possibilities for neurological diseases.

Do you need high-quality cell lines for your neurology research?

Download our comprehensive whitepaper, which covers the importance of NINDS and advanced biobanking practice in more detail.

Download white paper

References

1. The NINDS Human Cell and Data Repository – Providing iPSCs and Fibroblasts for the Study of Neurological Disease. March 1, 2021. Accessed October 29, 2024. https://nindsgenetics.org/

2. Zeng X, Chen Y, Sehrawat A, et al. Alzheimer blood biomarkers: practical guidelines for study design, sample collection, processing, biobanking, measurement and result reporting. Mol Neurodegener. 2024;19(1):40. doi:10.1186/s13024-024-00711-1

3. Jiao LL, Dong HL, Liu MM, et al. The potential roles of salivary biomarkers in neurodegenerative diseases. Neurobiology of Disease. 2024;193:106442. doi:10.1016/j.nbd.2024.106442

4. Król-Grzymała A, Sienkiewicz-Szłapka E, Fiedorowicz E, Rozmus D, Cieślińska A, Grzybowski A. Tear Biomarkers in Alzheimer’s and Parkinson’s Diseases, and Multiple Sclerosis: Implications for Diagnosis (Systematic Review). Int J Mol Sci. 2022;23(17):10123. doi:10.3390/ijms231710123

5. ISBER. Accessed October 30, 2024. https://isber.org

6. CDC. Health Insurance Portability and Accountability Act of 1996 (HIPAA). Public Health Law. September 10, 2024. Accessed October 30, 2024. https://www.cdc.gov/phlp/php/resources/health-insurance-portability-and-accountability-act-of-1996-hipaa.html

7. CFR – Code of Federal Regulations Title 21. Accessed October 30, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

Historically, many labs have relied on manual accessioning methods, which can be time-consuming and error-prone. Today, digital manifests are transforming how laboratories manage samples, offering significant time savings and reducing the risk of errors.

Here, we will explore the challenges associated with manual accessioning and how switching to digital processes can streamline the process by improving efficiency and accuracy.

The Challenges of Manual Accessioning

Manual accessioning involves physically labeling samples, manually entering data into logs, and tracking sample status through manually updated records. While simple, this process is inherently slow and labor-intensive. Laboratory staff must individually handle, label, and document each sample, which not only takes time but also introduces multiple opportunities for human error.

Common errors associated with manual processes include sample mislabeling, transcription mistakes, and incomplete documentation^1–3. These errors can lead to serious consequences, such as incorrect test results, delays in processing, and compromised data integrity. In clinical settings, such errors can impact patient safety, leading to misdiagnosis or delayed diagnosis. In research settings, data errors can invalidate results, wasting valuable time and resources.

Moreover, as sample volumes increase, these issues become more pronounced. Labs may struggle to keep up with the workload, leading to backlogs that further slow the testing process. During high-demand periods, the limitations of manual accessioning have become particularly evident, underscoring the need for more efficient solutions⁴.

How Digital Manifests Improve Efficiency

Digital manifests offer a powerful alternative to manual accessioning by streamlining the entire process through automation. By using technologies like barcodes and radio-frequency identification (RFID) tags, digital systems can automatically capture and store sample information, eliminating the need for manual data entry and reducing the risk of errors^2,5.

Benefits of Digital Accessioning

Automated Data Entry

Digital systems can automatically process sample information from barcodes or RFID tags as soon as a sample is received, significantly reducing the time required to process each sample. Automated data capture also reduces the risk of transcription errors, ensuring that sample information is accurately recorded².

Streamlined Sample Tracking

Digital accessioning systems provide real-time tracking of samples throughout the laboratory workflow. Samples can be easily located using digital records, reducing the time spent searching for missing samples^2,3. This is especially useful in high-throughput settings, where keeping track of a very large number of samples can be challenging⁴.

Enhanced Workflow Integration

Digital manifests seamlessly integrate with other laboratory information management systems (LIMS) and user platforms, facilitating the automatic transfer of sample data between systems. This integration streamlines the entire workflow, from sample receipt to analysis and reporting, further reducing processing time and enhancing overall efficiency.

Scalability and Flexibility

Unlike manual processes, digital systems are highly scalable, meaning they can easily handle increased sample volumes without a corresponding increase in workload. This scalability is especially important for labs that experience fluctuating demand or are required to scale up in line with project needs⁴.

Overcoming the Barriers to Adoption

While the benefits of digital accessioning are clear, some laboratories may be hesitant to make the switch due to concerns about cost or the need for new equipment and training. However, the long-term savings in time and resources often outweigh the initial investment. Additionally, many digital systems are designed to be user-friendly, minimizing the learning curve for staff. It is also essential to consider the potential for improved data integrity and compliance. Digital systems provide detailed audit trails, helping laboratories meet regulatory standards and maintain high levels of traceability. By reducing the risk of errors and improving data management, digital manifests not only save time but also enhance the overall reliability of laboratory operations.

Sampled’s Digital Accessioning Framework

At Sampled, we use a barcode-based sample accessioning system integrated with our core LIMS, LabVantage, and our proprietary system, SampledSphere, for customer access. Combining these digital components with robust quality control measures allows us to guarantee safe sample storage and efficient, reliable analytics to our customers in line with International Society for Biological and Environmental Repositories (ISBER) best practices and regulatory requirements^6,7.

Conclusion

Digital accessioning systems offer a faster, more accurate, and scalable solution to the challenges of manual processes. By automating data entry, streamlining sample tracking, and integrating seamlessly with other laboratory systems, digital accessioning can significantly reduce the time and effort required to manage samples, allowing labs to focus on what truly matters – delivering accurate and timely results.

For labs looking to enhance efficiency and improve the reliability of their workflows, transitioning to digital accessioning is a smart move.

To learn more about the benefits of digital manifests and how they can transform your laboratory operations, download our full white paper on this topic.

Download white paper

References

1. Nakhleh RE, Idowu MO, Souers RJ, Meier FA, Bekeris LG. Mislabeling of Cases, Specimens, Blocks, and Slides: A College of American Pathologists Study of 136 Institutions. Arch Pathol Lab Med. 2011;135(8):969-974. doi:10.5858/2010-0726-CPR

2. Norgan AP, Simon KE, Feehan BA, et al. Radio-Frequency Identification Specimen Tracking to Improve Quality in Anatomic Pathology. Arch Pathol Lab Med. 2020;144(2):189-195. doi:10.5858/arpa.2019-0011-OA

3. Nakhleh RE. Lost, Mislabeled, and Unsuitable Surgical Pathology Specimens: Pathol Case Rev. 2003;8(3):98-102. doi:10.1097/01.PCR.0000065693.59517.7E

4. Pettit ME, Boswell SA, Qian J, Novak R, Springer M. Accessioning and automation compatible anterior nares swab design. J Virol Methods. 2021;294:114153. doi:10.1016/j.jviromet.2021.114153

5. Snyder SR, Favoretto AM, Derzon JH, et al. Effectiveness of barcoding for reducing patient specimen and laboratory testing identification errors: A Laboratory Medicine Best Practices systematic review and meta-analysis. Clin Biochem. 2012;45(13-14):988-998. doi:10.1016/j.clinbiochem.2012.06.019

6. ISBER. Best Practices: Recommendations for Repositories Fifth Edition. Published online 2023. Accessed January 29, 2024. https://cdn.ymaws.com/www.isber.org/resource/resmgr/best_practices/ISBERBestPractices-5thEditio.pdf

7. Health Insurance Portability and Accountability Act of 1996 (HIPAA) | CDC. June 28, 2022. Accessed March 4, 2024. https://www.cdc.gov/phlp/publications/topic/hipaa.html

ISBER’s Mission and Global Impact

Mike Thurogood: Can you provide an overview of ISBER’s mission and how it supports the global biobanking community?

Dana Cooper: “ISBER is dedicated to advancing the expertise and quality of biorepositories and biobanking science worldwide. We support the global biobanking community by fostering collaboration, creating education and training opportunities, providing a forum for the dissemination of state-of-the-art policies, processes, and research findings, and offering an international showcase for innovative technologies, products, and services.”

Key Components of ISBER’s Best Practices for Repositories

Mike Thurogood: What are the key components of ISBER’s Best Practices for Repositories, and how do they enhance the quality and reliability of biobanked samples?

Dana Cooper: “The ISBER Best Practices, Fifth Edition, is the definitive global guide for managing and operating biobanks. These practices are either evidence-based or consensus-based and cover the collection, long-term storage, retrieval, and distribution of specimens. They promote the availability of high-quality biological and environmental specimens for future research. The fifth edition has been significantly revised based on user feedback, and it incorporates the Cryo addendum previously published for the fourth edition.”

Promoting Standardization and Innovation through Collaboration

Mike Thurogood: How does ISBER collaborate with other organizations and institutions to promote standardization and innovation in biobanking?

Dana Cooper: “ISBER is a global organization with membership and contributors from around the world. Our annual and regional meetings feature insights from diverse geographical locations. We collaborate with many biobanking consortia globally, which helps us stay aware of and contribute to the global biobanking community. This international collaboration promotes standardization and innovation in biobanking.”

Addressing Challenges in Biorepositories

Mike Thurogood: What are some common challenges faced by biorepositories today, and how do ISBER’s guidelines help address these issues?

Dana Cooper: “As biobanking grows worldwide, challenges include maintaining quality and standards, recognizing the value of biobanking, and securing systemic support for biobanks. ISBER’s activities and products, such as the Best Practices Fifth Edition and our educational programs, promote quality in biorepository operations and standardize specimen management. This helps biobanks address these challenges effectively.”

Conclusion

Our interview with Dana Cooper, MBA, BKin, CAE, Executive Director of ISBER, highlighted ISBER’s crucial role in advancing global biobanking expertise and quality. ISBER’s comprehensive best practices guide ensures the reliability of biobanked samples, supporting scientific research and medical advancements. Through international collaboration, ISBER promotes standardization and innovation, addressing challenges such as maintaining quality standards and securing systemic support. As a proud long-standing Gold ISBER member, we value ISBER’s significant impact on the biobanking landscape and appreciate Dana Cooper’s insights into this evolving field.

If you have any questions about ISBER or are interested in learning more please visit the ISBER website here.

It is well recognized that suboptimal preservation and long-term storage conditions can impact sample quality⁽¹⁾, therefore, it is critical that researchers ensure biosamples are stored in appropriate conditions such as Ultra Low Temperature Storage (ULT Storage) so the samples can be accessed and used in future research.

What is ULT Storage?

ULT Storage environments typically range from -80°C mechanical freezers all the way down to -196°C liquid nitrogen storage tanks. The exact storage temperature recommended can vary depending on sample type, preparation and intended use – generally speaking, the more sensitive the sample, the lower the storage temperature required.

Maintaining ULT Storage is a complex operation, especially when performed to ISBER Best Practices such as;

• Monitoring, recording and review of critical parameters.
• Backup power and/or alternate cooling systems alongside emergency response planning.
• Storage systems should be equipped with redundancy.

Outsourcing ULT Storage of biological samples in our Global Integrated Analytical Biorepository can help simplify these complexities for researchers as well as benefitting from; financial flexibility, expertise, new technology, operational efficiency, quality assurance and disaster recovery and focusing on research aims.

Understanding ULT Storage

ULT storage is critical for maintaining the integrity of biological samples, such as DNA, RNA, proteins, and cells. It involves keeping samples at extremely low temperatures to prevent metabolic processes and biochemical reactions that could degrade the samples. Typically, ULT storage temperatures range from -80°C, commonly used in laboratory freezers, to -196°C, achieved using liquid nitrogen storage systems. These temperatures ensure that biological materials are effectively “frozen in time,” preserving their structure and function for long-term use​.

Financial Benefits of Outsourcing ULT Storage

Outsourcing ultra-low temperature (ULT) storage could transform significant capital expenditures (CAPEX) into manageable operational expenditures (OPEX), allowing research institutions to avoid the high costs of purchasing and maintaining expensive equipment as well as energy consumption. This shift enhances financial flexibility by spreading costs over time and freeing up capital for other essential projects, aiding in better financial planning and resource allocation.

Furthermore, outsourcing ULT storage reduces financial risks associated with equipment maintenance, technological obsolescence, and regulatory compliance. Leveraging specialized storage providers ensures advanced infrastructure and expertise without the burden of costly upgrades and repairs, offering scalable solutions that adapt to changing research needs without significant financial strain.²

Expertise in Sample Management

Sampled specializes in ULT storage and brings a wealth of experience and expertise to biobank services. We are CAP accredited and operate to ISBER best practices, employing stringent protocols and advanced technologies to manage sample collections and monitor storage conditions of biological materials, ensuring samples are preserved optimally. This professional oversight minimizes the risk of sample loss or degradation due to equipment failure or improper handling​ or when storing biological materials.

Access to Technology

Outsourcing ULT storage gives researchers access to state-of-the-art equipment and facilities. Sampled continuously upgrades biostorage technologies, ensuring that the latest advancements in cryogenic sample storage are available to researchers.

Sampled invest in the latest technological advancements and methodologies in ULT freezer and cryogenic storage technologies. By outsourcing, researchers benefit from these upgrades without bearing the costs and logistical challenges of updating in-house systems especially cryogenic sample storage infrastructure which can be extremely prohibitive in terms of SIVL line installation and maintenance costs.

Access to Expertise and Efficiency

With over 25 years’ experience in biobank services, Sampled have specialized knowledge and expertise, ensuring optimal long term storage conditions and handling practices. This expertise is crucial in maintaining sample viability and quality, reducing the risk of sample degradation.

Outsourcing to Sampled offers scalable biological sample storage solutions that can adjust to the changing needs of research projects. Whether the storage requirement increases or decreases, Sampled can accommodate these changes without significant investments or disruptions to ongoing research​. We can even offer solutions for entire sample freezer storage (including your own freezers on our sites) freezer boxes or down to the individual primary vessels and create aliquots for backup storage.

Quality Assurance & Disaster Recovery

Outsourcing ultra-low temperature (ULT) storage to Sampled ensures rigorous quality control measures to maintain consistent and reliable storage conditions. These measures include regular inspections, continuous remote monitoring, and thorough maintenance protocols including comprehensive temperature mapping. This attention to detail ensures the integrity, cold chain, viability, and usability of biological samples at a range of storage temperatures for future research endeavors.

By maintaining stringent quality control standards, Sampled can mitigate against potential sample degradation and loss, ensuring that the biological material maintain integrity. This reliability is critical for the success of long-term research projects, as it guarantees that stored samples will retain their necessary properties and data integrity over extended periods even in cryostorage.

Another key for disaster recovery is the availability of on-site technical services teams, redundant systems and backup generators. Our Global Integrated Analytical biorespository was design with all these features based on over 25 years experience storing biological samples to ensure the optimal environment.

Focus on Research Aims

By outsourcing ULT storage, research institutions can allocate more resources to their core research activities. This shift allows researchers to focus on their scientific inquiries rather than the logistical challenges of managing ULT storage systems for biological materials​.

Conclusion

Outsourcing ULT storage to Sampled can offer significant benefits, including financial flexibility, expertise, new technology, operational efficiency, quality assurance and disaster recovery and focusing on research aims. By leveraging the expertise of the team here at Sampled, researchers can ensure the long-term preservation of their valuable biological samples while focusing on their core scientific activities. If you are considering outsourcing your ULT storage needs for biological samples, you can learn more about our Global Integrated Analytical Biorepository and biobanking services here.

References:

1. https://www.researchgate.net/publication/263014433_Storage_of_Human_Biospecimens_Selection_of_the_Optimal_Storage_Temperature
2. https://academic.oup.com/femsre/article/29/5/897/547905

The Central Role of Sample Collection Kitting in Research and Diagnostics

Central to the success of any research or diagnostic workflow involving biological samples, the process of sample collection determines the accuracy of results, the reliability of data, and the success of research outcomes or new therapeutic developments. For example, in the realm of drug development, the collection of cell samples is essential for assessing the efficacy and safety of new compounds¹. Similarly, in genomic research, the precision in sample collection is directly linked to the accuracy of sequencing and gene expression analyses², while in diagnostics, the integrity of patient samples is crucial for test sensitivity and specificity³.

Sample Collection Kitting Challenges and Implications

However, despite the critical role of sample collection, researchers encounter numerous obstacles that can significantly affect the integrity of their research and the validity of results^4–6.

Common challenges in sample collection kitting include:

• Lack of understanding of the sample and optimal collection methods.
• Inconsistent sampling techniques.
• Sample contamination or damage.
• Loss of sample integrity.
• Limited sample availability.
• Safety issues such as exposure to hazardous materials.
• Time- and labor-intensive protocols which act as a barrier to productivity.

Strategies for Success

Central to overcoming these challenges is gaining an in-depth understanding of the sample and its collection, processing, and storage requirements⁷. Gaining such knowledge and experience takes time, especially given the high number of diverse sample types often dealt with by a lab. Moreover, precision and consistency are paramount in overcoming these challenges, which require researchers to spend time developing and optimizing standardized protocols if optimal protocols are not available⁸. It is also essential that any relevant regulations and data protection laws are adhered to^9,10, which requires extensive knowledge and a commitment to staying abreast of any changes or updates.

Gaining all of this sample-specific knowledge and experience, as well as developing and optimizing standard protocols for the lab to follow, can be challenging and time-consuming and can negatively impact laboratory productivity. Thus, it can be hugely beneficial to outsource this effort by working with a highly knowledgeable service provider on sample collection.

The Solution: Custom Kitting Services by Sampled

Sampled offers a custom sample collection kitting service designed to streamline the sample collection process for our clients. The kits, tailor-made to meet the client’s needs, are constructed from high-quality materials and are comprehensively quality-checked prior to distribution. Our sample collection kitting services are designed to meet the specific requirements of different sample types, addressing the unique challenges each type presents. Our experts are knowledgeable about sample characteristics and collection methodologies and stay abreast with regulatory changes, which they use to inform the development of our kits, minimizing the risk of sample degradation and contamination and ensuring compliance with regulatory guidelines and data protection laws.

Aside from benefits to sample integrity and resulting data reliability, utilizing Sampled’s custom kitting service can be hugely beneficial for improving laboratory efficiency and productivity. All our sample collection kits come with a single page of simple, easy-to-follow instructions for workflows that are as streamlined as possible. Protocols always follow best practices and are standardized, minimizing variability and maximizing reproducibility in sample collection¹¹. Finally, all sample collection components are barcoded, which streamlines the sample’s transportation, processing, storage, and access, and enables a full chain of custody throughout the sample’s lifecycle.

Conclusion

The significance of successful sample collection in the integrity and reliability of data resulting from analytical workflows cannot be overstated. Challenges inherent to the sample collection process, often stemming from an insufficient understanding of sample requirements or non-standardized protocols, can severely impede the success of these workflows. Sampled offers a custom sample collection kitting service that presents a robust solution to these challenges. Through extensive knowledge and expertise in sample characteristics and collection methodologies, the development of bespoke sample collection kits not only streamlines the collection process but also enhances sample integrity and compliance with regulatory standards, thereby elevating the quality and reliability of research and diagnostic pipelines.

Download the full whitepaper today to learn more about the importance of standardized sample collection procedures and how custom kitting services can help you elevate your sample collection and improve resulting data. 

References

1.            Maass KF, Barfield MD, Ito M, et al. Leveraging patient‐centric sampling for clinical drug development and decentralized clinical trials: Promise to reality. Clin Transl Sci. 2022;15(12):2785-2795. doi:10.1111/cts.13411

2.            Szczepek AJ, Frejo L, Vona B, et al. Recommendations on Collecting and Storing Samples for Genetic Studies in Hearing and Tinnitus Research. Ear Hear. 2019;40(2):219-226. doi:10.1097/AUD.0000000000000614

3.            Nichols ZE, Geddes CD. Sample Preparation and Diagnostic Methods for a Variety of Settings: A Comprehensive Review. Molecules. 2021;26(18):5666. doi:10.3390/molecules26185666

4.            Logie JJ, Chaloner C. A national survey of specimen contamination in the UK. Ann Clin Biochem Int J Lab Med. 2019;56(2):219-227. doi:10.1177/0004563218812500

5.            Vester AE, Christensen EF, Andersen SK, Tønnesen E. Ethical and practical problems in blood sampling for research purposes during pre‐hospital emergencies. Acta Anaesthesiol Scand. 2005;49(10):1540-1543. doi:10.1111/j.1399-6576.2005.00789.x

6.            Santos J, Ramos C, Vaz-Velho M, Vasconcelos Pinto M. Occupational Exposure to Biological Agents. In: Arezes PM, Boring RL, eds. Advances in Safety Management and Human Performance. Vol 1204. Advances in Intelligent Systems and Computing. Springer International Publishing; 2020:61-67. doi:10.1007/978-3-030-50946-0_9

7.            Redrup MJ, Igarashi H, Schaefgen J, et al. Sample Management: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J. 2016;18(2):290-293. doi:10.1208/s12248-016-9869-2

8.            Dinis-Oliveira RJ, Vieira DN, Magalhães T. Guidelines for Collection of Biological Samples for Clinical and Forensic Toxicological Analysis. Forensic Sci Res. 2016;1(1):42-51. doi:10.1080/20961790.2016.1271098

9.            Health Insurance Portability and Accountability Act of 1996 (HIPAA) | CDC. Published June 28, 2022. Accessed March 4, 2024. https://www.cdc.gov/phlp/publications/topic/hipaa.html

10.         UCL. Transporting Infectious and Biological Material. Safety Services. Published August 3, 2020. Accessed March 20, 2024. https://www.ucl.ac.uk/safety-services/policies/2022/dec/transporting-infectious-and-biological-material

11.         ISBER. Best Practices: Recommendations for Repositories Fifth Edition. Published online 2023. Accessed January 29, 2024. https://cdn.ymaws.com/www.isber.org/resource/resmgr/best_practices/ISBERBestPractices-5thEditio.pdf