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

In this article we will look at how safe and correct storage of samples is crucial from the nascent stages of drug discovery to post-market surveillance and how Sampled’s biorepository services can play a pivotal role in advancing medical breakthroughs.

1. Role of biobanking in early Research and Development:

In the initial stages of drug discovery, researchers must rely on access to high-quality biological specimens to unravel the underlying mechanisms of diseases and identify potential therapeutic targets. Sampled’s biobanking infrastructure serves as a vital resource, enabling researchers to securely store and access a diverse array of samples, including:

• DNA/RNA
• Whole blood
• Serum
• Saliva
• Urine
• Stool
• Hair
• Cell pellets
• Protein Samples

By providing centralized storage facilities equipped with state-of-the-art preservation technologies, Sampled empowers researchers to accelerate the pace of discovery and validation of novel drug candidates as well as biomarker discovery. Furthermore, our secure facilities are monitored 24 hours a day, all year round with multiple backup power generators to ensure their security and integrity.

2. Preclinical Testing:

As drug candidates progress through preclinical testing, the demand for well-characterized biological samples becomes increasingly critical. Sampled holds both CAP and CLIA licenses so that our biorepository sample storage services facilitate the procurement and distribution of meticulously annotated specimens, thereby streamlining preclinical studies and enhancing the reproducibility of research outcomes. Additionally, by offering customizable sample management and biobanking solutions, Sampled enables researchers to optimize experimental protocols and improve the predictive value of preclinical models, ultimately reducing the risk of late-stage drug failures.

3. Clinical Trials:

Throughout the clinical trial phase, the availability of high-quality biospecimens is indispensable for assessing drug safety, efficacy, and pharmacokinetics. Sampled’s expertise in sample collection, processing, and biosample storage ensures compliance with stringent regulatory requirements while maintaining sample integrity and traceability. By leveraging Sampled’s comprehensive biobanking infrastructure, pharmaceutical companies can mitigate the logistical challenges associated with multi-site clinical trials, streamline sample logistics, and enhance data quality, thereby expediting the development timeline and reducing costs.

The ability to package, transport and store samples in a systematic and highly structured manner by following best practices gives researchers the confidence that their sample’s integrity is intact which means the data generated from them is accurate and reproducible. Furthermore, our ability to scale to meet your sample storage needs through every stage of your clinical trial means that you can focus on what matters most instead of setting up a new, or expanding an existing, biorepository. 

4. Post-Market Surveillance:

Even after a drug/therapeutic has been approved for market release, the need for continuous monitoring of safety and efficacy remains paramount. Sampled’s biobanking services extend beyond the realm of drug development and supports post-market surveillance initiatives aimed at detecting adverse drug reactions, monitoring long-term outcomes, and evaluating real-world effectiveness. By establishing longitudinal sample collections linked to comprehensive clinical data, Sampled empowers researchers to conduct retrospective analyses and identify emerging safety signals, thereby safeguarding public health and informing regulatory decision-making.

Similarly, another consideration to be made for pharmaceuticals is how their archived or legacy sample collections (perhaps through acquisitions or donations) are processed and stored. It is crucial that your documenting and SOPs for storing multiple sample collections is standardized across the entire collection so that sample integrity is prioritized but also so that they are categorized correctly. Failure to properly organize and maintain high uniform storage conditions can result in some sample collections being lost, mislabeled or destroyed by mistake.

In conclusion, Sampled’s biobanking services represent a cornerstone of the drug discovery pipeline, offering versatile solutions that span multiple stages of pharmaceutical research and development. By providing researchers with access to a wide range of storage solutions from ambient storage to -196°C Liquid Nitrogen tanks, coupled with robust infrastructure and tailored support services, Sampled accelerates the pace of innovation and fosters collaboration across the biomedical community. As the search for transformative therapies continues, Sampled remains committed to advancing precision medicine and driving the next wave of scientific breakthroughs.

If you would like to learn more about our Biobanking services, speak to one of our experts today

Q1: Can you tell us a bit about yourself and your role at Sampled?

I founded the Sampled Scientific Affairs Department with the mission to provide expert technical resources to clients, discovery and adoption of new technologies and the coordination of outreach initiatives designed to enhance the profile of the company. After a career as an academic researcher spanning more than two decades, I 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. I’m proud to have been a member of the team that established the SAMPLED SARS-CoV2 testing lab, serving the states of New Jersey and Minnesota as well as many sites across the United States.

Q2: Can you tell us what biobanking involves and why it’s so important to store your samples correctly?

Genetic studies designed to elucidate the causes of human disorders with the goal of developing treatments depend on the collection and analysis of large numbers of biological samples of utmost quality.   At the heart of the process, Biobanking involves the collection, processing, storage, and distribution of these samples for research, clinical, or diagnostic purposes. It’s crucial to store samples correctly to maintain their integrity and viability over time. Correct processes leading up to meticulous storage protocols ensure that researchers have access to high-quality samples for current and future studies. Incorrect storage conditions can compromise sample quality, leading to inaccurate results and potentially undermining the validity of research findings. Therefore, storing samples in controlled environments with monitored temperature and security measures is essential to preserve their biological properties and maximize their utility for scientific inquiry.

Q3: What is involved in setting up a high quality, functional biobank? What can researchers expect?

Setting up a high-quality, functional biobanking operations requires careful planning, investment in infrastructure, and adherence to stringent quality standards. Researchers can expect a comprehensive process that includes:

Facility Design: Designing a biobank facility involves considerations such as layout optimization, temperature control systems, security protocols, and backup power supply to ensure uninterrupted sample storage. This means securing a large space within your facility in order to house all of the equipment and samples.

Equipment Acquisition: Procuring specialized equipment such as ultra-low temperature freezers, liquid nitrogen tanks, and automated sample handling systems is essential for maintaining sample integrity and accessibility.

Quality Management Systems: Implementing robust quality management systems, including standard operating procedures (SOPs), quality control measures, and documentation protocols, is crucial for ensuring compliance with regulatory requirements and maintaining sample quality.

Data Management: Establishing secure data management systems for tracking sample information, storage locations, and relevant metadata is essential for efficient sample retrieval and traceability.

Staff Training: Providing comprehensive training for staff members involved in sample handling, storage, and management is critical to ensure adherence to standard protocols and best practices.

Overall, researchers should expect a significant time and resource cost in order to establish a biobank that prioritizes sample integrity, regulatory compliance, and efficient sample management.

Q4: What are the advantages of outsourcing sample storage to a service provider such as Sampled?

Outsourcing sample storage to a service provider like Sampled offers several advantages:

Cost Savings: Outsourcing eliminates the need for investing in infrastructure, equipment, and personnel required for in-house sample storage, resulting in cost savings for researchers.

Expertise and Experience: Sampled brings extensive experience and expertise in sample storage and management, ensuring optimal storage conditions and adherence to quality standards. Our track record of support for some of the largest genetic studies in the world, funded by NIH and major pharma, gives our clients the confidence to put their precious and irreplaceable samples in our hands from the point of collection through processing, analysis and sharing with the global community.

Scalability and Flexibility: Sampled’s facilities are equipped to accommodate varying sample volumes and storage requirements, providing researchers with scalable and flexible storage solutions.

Risk Mitigation: By outsourcing sample storage, researchers mitigate risks associated with equipment failure, natural disasters, and regulatory non-compliance, as Sampled assumes responsibility for maintaining sample integrity and security.

Focus on Core Research Activities: Outsourcing sample storage allows researchers to focus on their core research activities, without the burden of managing sample storage logistics.

Q5: Tell us why Sampled has positioned itself to be the world’s only Global Integrated Analytical Biorepository (GIAB) and what impact that has on researchers?

Sampled has positioned itself as the world’s only Global Integrated Analytical Biorepository (GIAB) by integrating sample storage with analytical capabilities, providing researchers with comprehensive “end to end” solutions for sample management and analysis. This integration enables researchers to access not only stored samples but also analytical services such as sample characterization, biomarker discovery, and genomic sequencing within the same facility.

By offering a one-stop solution for sample storage and analysis, Sampled streamlines the research process, reduces turnaround times, and enhances research efficiency. This integrated approach empowers researchers with a deeper understanding of their samples and facilitates translational research efforts, ultimately accelerating scientific discovery and innovation. As a result, Sampled’s GIAB model has a profound impact on researchers by providing them with comprehensive support and resources to advance their research goals effectively.

If you want to learn more about our biobanking services, contact one of our experts here

How the Sampled’s GIAB Meets the Challenges of PBMC Isolation

As living cells, PBMCs are vulnerable to many environmental variables. Temperature and time before processing can affect cell viability and impact immunological phenotypes such as cytokine production, which can hamper studies that require statistically reproducible results. Here, we break down the different stages of PBMC isolation and discuss how mismanagement of these processes can ruin studies and lead to long and costly delays in the drug development pipeline. For each challenge discussed, we provide a description of the robust solutions that Sampled’s GIAB offers.

Logistics and Processing

PBMCs are best isolated from whole blood within twenty-four hours of phlebotomy, and that has not been frozen. In multicentre trials, whole blood samples can be subjected to temperatures ranging from  -1 °C to 35 °C, affecting viability⁴, the effectiveness of cryopreservation⁵, and important immunological phenotypes⁴. Time prior to analysis is also an important factor⁶. Contamination with other cell types such as granulocytes can occur during PBMC isolation and affect T-cell activation⁷. Thus, robust and reproducible isolation protocols are essential.

How the Sampled’s GIAB enhances PBMC logistics and processing

Streamlined Logistics and Data Storage

We provide optimal transport materials through our custom kitting service and organize a trusted courier to ensure all samples arrive on time and are maintained in optimal conditions. We also ensure accurate and secure data collection and storage and allow clients to view and audit their data via our cloud platform, SampledSphere.

Automated and Manual Processing

At Sampled, we use the Hamilton EasyBlood, a high-capacity automated instrument for PBMC isolation. Automation minimizes human errors and allows samples to be processed simultaneously, preventing inter-run variation and ensuring the isolation of a pure pool of PBMCs. We also have on-site experts to perform manual isolation for challenging, low-volume, or low-cell number samples. This combination allows us to maximize study success.

Sample Handling and Storage

Handling and storage conditions can introduce variables that impact PBMC viability and function. In fact, temperature prior to cryopreservation of PBMCs can significantly impact immunological phenotypes after thawing, such as interferon-gamma production by T-cells⁵. Lack of suitable storage capacity can mean that precious samples are left to deteriorate and cannot be used for follow-up studies. Large longitudinal studies can require decades of secure dedicated storage space that many facilities cannot provide. Furthermore, having reliable backup plans for power outages and freezer breakdowns can make the difference between study success and needing to start from scratch.

Sampled’s GIAB Provides Handling and Storage Capacity to Meet the Requirements of any Study

Storage

The Sampled GIAB is home to 600 -80 °C freezers with a capacity for 1,000 freezers and adheres strictly to the International Society for Biological and Environmental Repositories standards⁸. This means no sample is left to deteriorate at suboptimal conditions and we can accommodate large-scale studies that require high-volume, secure storage.

Study Management

We work with clients to immortalize samples, ensuring, where possible, that there is enough left over for future studies. Our broad processing capabilities mean we can process and store multiple important biomolecules from PBMCs, such as DNA, protein, and serum.

Disaster Recovery

Sometimes disasters like freezer malfunctions are unavoidable, and having a detailed disaster recovery plan can help to mitigate risk. Sampled offers an on-call team of technical experts who can retrieve your samples and store them in our freezers with dedicated alarms and multiple backup generators, helping to secure your samples should the worst happen.

Analytical Considerations

Data analysis is where all of the variables introduced in PBMC processing appear, and it can be challenging to determine what results are genuine and which are artifacts. Quality control (QC) is important to determine cell viability and number and can help identify confounding variables that may have been introduced. As such, failure to perform QC can waste time and resources.

How Sampled’s GIAB Enhances Data Analysis

QC

For PBMC counting and viability tests, Sampled uses standardized pre-calibrated single-use cassettes and automated fluorescence microscopy (ChemoMetec Nucleocounter®). We perform plasma QC with the Lunatic spectrophotometer from Unchained Labs and cDrop analysis software. QC saves time and resources by ensuring only good-quality samples are brought forward for analysis.

Dedicated Bioinformatics Team

Sampled has a team of expert bioinformaticians who can use sophisticated analyses that take confounding factors into account. Even if damaging variables have been introduced, our team can salvage your data, allowing you to achieve study success even where best practices were not followed.

PBMCs are pivotal in immunological research and many drug discovery pipelines. However, PBMC processing is fraught with challenges, including variability in isolation and environmental sensitivity, which can compromise research integrity. Sampled’s GIAB addresses these obstacles through streamlined logistics, robust quality control, and advanced storage solutions, ensuring sample viability and purity. By mitigating variables at each processing stage, the Sampled GIAB enhances the reproducibility of immunological research, accelerating drug development and improving study outcomes.

If you want to learn more about how Sampled’s GIAB can help you succeed with PBMC studies, you can check out our latest white paper[1] .

References

1. Lim WA, June CH. The Principles of Engineering Immune Cells to Treat Cancer. Cell. 2017;168(4):724-740. doi:10.1016/j.cell.2017.01.016
2. Speiser DE, Chijioke O, Schaeuble K, Münz C. CD4+ T cells in cancer. Nat Cancer. 2023;4(3):317-329. doi:10.1038/s43018-023-00521-2
3. Serra V, Fiorillo E, Cucca F, Orrù V. Quantifying the Detrimental Effects of Multiple Freeze/Thaw Cycles on Primary Human Lymphocyte Survival and Function. Int J Mol Sci. 2022;24(1):634. doi:10.3390/ijms24010634
4. Olson WC, Smolkin ME, Farris EM, et al. Shipping blood to a central laboratory in multicenter clinical trials: effect of ambient temperature on specimen temperature, and effects of temperature on mononuclear cell yield, viability and immunologic function. J Transl Med. 2011;9(1):26. doi:10.1186/1479-5876-9-26
5. Owen RE, Sinclair E, Emu B, et al. Loss of T cell responses following long-term cryopreservation. J Immunol Methods. 2007;326(1-2):93-115. doi:10.1016/j.jim.2007.07.012
6. Yi PC, Zhuo L, Lin J, Chang C, Goddard A, Yoon OK. Impact of delayed PBMC processing on functional and genomic assays. J Immunol Methods. 2023;519:113514. doi:10.1016/j.jim.2023.113514
7. Agashe C, Chiang D, Grishin A, et al. Impact of granulocyte contamination on PBMC integrity of shipped blood samples: Implications for multi-center studies monitoring regulatory T cells. J Immunol Methods. 2017;449:23-27. doi:10.1016/j.jim.2017.06.004
8. ISBER. Accessed February 16, 2024.
9. Lim WA, June CH. The Principles of Engineering Immune Cells to Treat Cancer. Cell. 2017;168(4):724-740. doi:10.1016/j.cell.2017.01.016
10. Speiser DE, Chijioke O, Schaeuble K, Münz C. CD4+ T cells in cancer. Nat Cancer. 2023;4(3):317-329. doi:10.1038/s43018-023-00521-2
11. Serra V, Fiorillo E, Cucca F, Orrù V. Quantifying the Detrimental Effects of Multiple Freeze/Thaw Cycles on Primary Human Lymphocyte Survival and Function. Int J Mol Sci. 2022;24(1):634. doi:10.3390/ijms24010634
12. Olson WC, Smolkin ME, Farris EM, et al. Shipping blood to a central laboratory in multicenter clinical trials: effect of ambient temperature on specimen temperature, and effects of temperature on mononuclear cell yield, viability and immunologic function. J Transl Med. 2011;9(1):26. doi:10.1186/1479-5876-9-26
13. Owen RE, Sinclair E, Emu B, et al. Loss of T cell responses following long-term cryopreservation. J Immunol Methods. 2007;326(1-2):93-115. doi:10.1016/j.jim.2007.07.012
14. Yi PC, Zhuo L, Lin J, Chang C, Goddard A, Yoon OK. Impact of delayed PBMC processing on functional and genomic assays. J Immunol Methods. 2023;519:113514. doi:10.1016/j.jim.2023.113514
15. Agashe C, Chiang D, Grishin A, et al. Impact of granulocyte contamination on PBMC integrity of shipped blood samples: Implications for multi-center studies monitoring regulatory T cells. J Immunol Methods. 2017;449:23-27. doi:10.1016/j.jim.2017.06.004
16. ISBER. Accessed February 16, 2024. https://isber.org

Haris Choudhery (HC): Talk us through why it’s so important to get PBMC isolation done correctly and what downstream applications it leads to

Jennifer Moore (JM): PBMC isolation is crucial because it enables researchers to separate peripheral blood mononuclear cells (PBMCs) from whole blood, allowing for focused study on these specific cells. Correctly isolating these PBMCs ensures purity and viability, which is essential for downstream applications such as biomarker discovery, drug development, oncology research, and clinical trials. PBMCs serve as valuable indicators of immune response, disease progression, and treatment efficacy in various medical and research contexts. Therefore, accurate isolation of these cells is fundamental to obtaining reliable data as failing to do this can lead to low reproducibility between investigations.

HC: Why might researchers choose to automate PBMC isolation instead of manually isolating them?

JM: Researchers often opt for automated PBMC isolation for several reasons. Firstly, automation streamlines the process, reducing human error and variability inherent in manual isolation techniques. This consistency ensures reproducibility and reliability of results which is critical for research validity. Additionally, automation increases throughput, enabling the processing of larger sample volumes in a shorter time frame, which is advantageous for high-throughput studies or clinical trials. Furthermore, automated systems often offer integrated data management, traceability, and quality control features, enhancing efficiency and compliance with regulatory standards.

HC: What hurdles do researchers face when isolating PBMCs themselves?

JM: Researchers will encounter various challenges when isolating PBMCs if they are unfamiliar with best practices and standard operating procedures. Regarding manual isolation methods, these can be labor-intensive, time-consuming, and prone to inconsistencies, leading to variable outcomes. Achieving high purity and viability of PBMCs consistently requires expertise and experience in handling blood samples and performing centrifugation techniques. Additionally, manual workflows pose risks of contamination and sample mishandling, jeopardizing data integrity and experimental validity. Moreover, manual isolation may not be scalable for studies requiring processing of large sample cohorts, limiting research efficiency and productivity.

HC: How easy or difficult is it to set up automated PBMC isolation in your own labs?

JM: Researchers who are new to automated PBMC isolation may encounter several challenges or hurdles:

• Initial Investment: Acquiring automated PBMC isolation equipment represents a significant upfront capital expenditure for research laboratories, which may pose financial challenges, especially for smaller or resource-constrained institutions.

• Technical Complexity: Operating automated systems requires technical expertise and training. Researchers may face a learning curve in understanding the operation, maintenance, and troubleshooting of the equipment and software.

• Protocol Optimization: Despite being automated, PBMC isolation protocols may still require optimization to ensure optimal performance and yield. Researchers may need to experiment with various parameters to achieve desired results. This may increase turn around times initially while researchers learn how to achieve the desired results.

• Integration with Workflows: Integrating automated PBMC isolation into existing laboratory workflows and processes can be challenging. Researchers need to ensure seamless integration with sample handling, data management, and downstream analysis procedures.

• Quality Control: Maintaining quality control measures is crucial in automated PBMC isolation to ensure consistency and reliability of results. Researchers must establish robust quality control protocols and monitor process parameters effectively.

• Validation and Compliance: Validating automated PBMC isolation protocols and ensuring compliance with regulatory standards are essential but can be time-consuming and complex processes requiring careful documentation and adherence to guidelines.

Overall, while automated PBMC isolation offers numerous benefits, researchers new to this technology must navigate various challenges to maximize its potential and integration into their research workflows.

HC: How does Sampled help researchers who require PBMC isolation? What are the benefits of outsourcing PBMC isolation?

JM: Sampled provides comprehensive PBMC isolation services, offering researchers a range of benefits:

• Expertise: Sampled’s experienced team ensures accurate and reproducible PBMC isolation using well established protocols and state-of-the-art equipment, such as the Hamilton EasyBlood platform, which minimizes variability and ensures reproducibility.

• Efficiency: Outsourcing PBMC isolation to Sampled saves researchers time and resources by eliminating the need for specialized equipment, personnel training, and protocol optimization. This allows researchers to focus on core research activities and accelerate project timelines whilst saving on capital expenditure.

• Quality Assurance: Sampled maintains rigorous quality control measures throughout the isolation process, ensuring high purity and viability of PBMCs for downstream applications. This commitment to quality assurance provides researchers with confidence in the reliability and consistency of their data.

• Scalability: Sampled can meet your changing needs and enables processing of large sample volumes efficiently, catering to diverse research needs and timelines. Whether for small-scale studies or high-throughput projects, Sampled offers flexible solutions to meet researcher requirements.

In summary, outsourcing PBMC isolation to Sampled offers researchers a convenient, reliable, and cost-effective solution, enabling them to obtain high-quality PBMCs for their research endeavors.

If you would like to learn more about our automated PBMC isolation services and the advantages of outsourcing this service, contact one of our experts today

In this evolving paradigm, the need for sophisticated analytical platforms and robust biorepositories has become paramount. Sampled’s Global Integrated Analytical Biorepository (GIAB) emerges as a cornerstone for researchers, offering unparalleled capabilities in managing and analyzing complex biological samples. In this article we look at 5 reasons how the GIAB is poised to revolutionize clinical trials.

1. Access to Expertise

At the heart of Sampled’s GIAB lies our team of technical experts. With extensive experience in biobanking, sample processing, kitting and multiomics analysis, our experts ensure the highest standards of sample management, storage, and analysis by following up to date SOPs and best practices.

One example of how our experts can help is when it comes to completing sequencing investigations, this type of research can be daunting if you are new to sequencing or have never performed whole exome sequencing before. Even if you have the right sequencing platform in-house, you may not have the right team of experts to sequence your samples, and just one mistake in sequencing can result in costly errors that could lose your team time and resources.

This is especially important to consider if the sample you’re looking to sequence is finite or irreplaceable such as patient samples. This is another reason why researchers are outsourcing their work to Sampled, as our highly trained experts are able to help you with experimental design and reduce turn-around-times.

2. Compliance with Clinical Trial Regulatory Bodies

Navigating the regulatory landscape is a daunting challenge for pharmaceutical companies conducting clinical trials. Our GIAB alleviates this burden by adhering rigorously to regulatory guidelines and industry best practices. For example, regulatory bodies such as the FDA require access to a wide range of data from cryostorage temperature logs for samples that were transported between sites to genomic data. If your data is unreliable, inaccurate or does not comply with their rules and regulatory standards it could spell disaster and delay the product’s release.

Outsourcing cryogenic storage to our GIAB, ensures samples are stored under regulatory-compliant conditions, facilitating smooth regulatory review processes. This is because our team of experts are trained to follow the latest SOPs that conform to processes laid out by regulatory bodies such as the FDA. Not only will your sample’s integrity be preserved for years to come, but they will also meet the requirements laid out by major regulatory bodies should they be recalled from storage for review.

3. Cost-effective and Resource Optimization

Running clinical trials, especially those involving biologics, demands significant financial resources and infrastructure. Sampled’s GIAB offers a cost-effective solution by streamlining sample management processes and optimizing resource utilization. By outsourcing sample handling and analysis to Sampled, researchers can minimize overhead costs associated with in-house biorepositories (which can be prohibitively expensive in labs based in major cities) and focus their resources on core research activities, accelerating the pace of drug development.

Likewise, by outsourcing research to our trained experts, researchers can save on overheads associated with hiring and training new staff which saves on capital expenditure and time. Similarly, since Sampled is a service partner with many major platform manufacturers such as 10X Genomics, Illumina, Olink, PacBio and Twist Biosciences, researchers no longer need to purchase costly platforms. Instead, they can work with Sampled’s experts to ensure their samples are analyzed in the manner they wish without having to spend time optimizing multiple platforms and maintaining them.

4. Centralized Sample Management

One of the most significant advantages of Sampled’s GIAB is its centralized sample management system. By consolidating samples from multiple clinical sites into a single biorepository, our GIAB facilitates seamless collaboration and data sharing among researchers. This centralized approach not only enhances efficiency but also ensures sample consistency and uniformity, mitigating variability and improving the reliability of research outcomes.

By taking a consistent and uniform approach to sample storage, management analysis and kitting, researchers can significantly reduce the risk of generating results that are not reproducible. In turn giving researchers the confidence that the results they are seeing are not only accurate but reproducible.

5. Enhanced Data Security and Quality Control

Data security and quality control are paramount in clinical research, especially when dealing with sensitive patient information and biological samples. Our GIAB employs stringent protocols and SOPs to safeguard data integrity and confidentiality. From robust data encryption to real-time monitoring of sample conditions, Sampled prioritizes data security and implements rigorous quality control measures at every stage of the sample lifecycle.

In conclusion, Sampled’s GIAB stands at the forefront of innovation in clinical trial management, offering researchers a comprehensive solution for handling, storing and analyzing complex biological samples. With our expertise, regulatory compliance know how, cost-effectiveness and centralized sample management, we are poised to revolutionize the way clinical trials are conducted in the era of biologics dominance. Ultimately, helping researchers to unlock new insights, accelerate drug discovery, and improve patient outcomes.

Speak to one of our experts today to learn more about how we can help your clinical research

Key Considerations for Robust Pre-analytical Work

1. Sample Collection and Processing: Proper sample preparation is the first step in ensuring sample integrity and analytical accuracy. Common sample collection and processing challenges include suboptimal collection apparatus, processing delays, inappropriate processing temperatures, and human errors⁵. These issues, which may seem minor, can have significant impacts: damaging proteins, DNA, and RNA, affecting analytical outcomes, and making distinguishing between true biological changes and procedural artifacts challenging⁶. Moreover, there is often a lack of standardization in pre-analytical processes, which can lead to variable results, even among case-matched samples⁷. Implementing strict functional quality control (FQC) measures, including visual inspection and functional QC, is critical to retaining sample quality, avoiding wasted time, resources, and money, and ascertaining the validity of research findings⁸.
2. Sample Handling and Storage: [2] After collection and processing, samples must be aliquoted and stored under specific, temperature-controlled conditions. The optimal storage temperature is determined by the sample type, storage duration, and retrieval frequency, and getting this right is pivotal since incorrect storage temperatures can lead to loss of sample viability and integrity, particularly detrimental for precious patient samples or rare cell lines. Selecting the most suitable storage vessel and strategically storing aliquots are also essential for preserving sample utility and ensuring efficient tracking and retrieval⁹. Disaster recovery measures, such as backup generators, alarmed continuous temperature monitoring systems, and on-call technicians, are critical to protect against catastrophic sample loss in case of system failure or natural disaster. Moreover, implementing measures to prevent sample degradation and contamination during handling, such as limiting freeze-thaw cycles and handling samples under aseptic environments, is essential for preserving sample quality and ensuring the reliability of subsequent analyses^10–12.
3. Analytical Considerations: The strategic selection of the most optimal analytical method considering the impact of pre-analytical processes is an often overlooked but nonetheless critical component of the pre-analytical phase, with significant implications for the quality and consistency of research outcomes. When planning projects, researchers should consider factors related to pre-analytical processes, including the sensitivity of assays to sample degradation and the requirement for fresh samples¹³, alongside practical limitations such as resource availability and processing capacity. Distinguishing actual biological changes from pre-analytical variations is essential for ensuring data validity and facilitating comparisons across studies¹⁴. This requires rigorous pre-analytical QC and detailed documentation of sample handling procedures to identify and minimize pre-analytical errors, ultimately conserving resources by avoiding the analysis of degraded or unsuitable samples. Moreover, variability in equipment, methodologies, and processing techniques between different sites can introduce notable inconsistencies in data and should be standardized or minimized by using a single service provider¹⁵.

The Global Integrated Analytical Biorepository Strategy for Robust Pre-analytical Work

Sampled is the world’s first Global Integrated Analytical Biorepository (GIAB)[3] , providing a new, innovative pathway for biorepository services by combining traditional sample storage with a comprehensive array of pre-analytical and analytical services. Unlike standard biorepositories that focus mainly on sample storage and access, Sampled offers an integrated solution encompassing sample storage, processing, and logistics, cellular services, advanced multiomics, and bioinformatic analysis. This integrated approach supports a wide range of research needs through streamlined sample management, analysis, and reporting, thus accelerating research and development efforts. Notably, the integration of all the required services of a research project, from sample collection to data analysis and transfer, along with a full chain of custody and robust pre-analytical measures, ensures sample integrity and data validity throughout the process.

Sampled’s GIAB supports robust pre-analytical work through services such as:

• Clinical and research kitting
• Robust sample accessioning procedures
• Stringent QC
• Disaster recovery
• Transparent reporting

Ultimately, the GIAB approach ensures sample integrity and data reliability by coupling streamlined sample collection support with stringent quality controls, advanced sample accessioning, and a customizable reporting system. Its integrated, end-to-end model facilitates seamless sample collection to data reporting by a single provider, guaranteeing accurate and reliable data for successful research and clinical analysis and representing a comprehensive solution to the significant challenges associated with suboptimal pre-analytical work.

If you’re interested in learning more about the key components of robust pre-analytical work, check out our latest white paper. We delve deeper into the specifics and explore how Sampled’s GIAB approach supports this critical research phase for data you can trust.

References

1.  Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020;323(9):844. doi:10.1001/jama.2020.1166

2.  Brown DG, Wobst HJ, Kapoor A, Kenna LA, Southall N. Clinical development times for innovative drugs. Nat Rev Drug Discov. 2022;21(11):793-794. doi:10.1038/d41573-021-00190-9

3.  Plebani M. Quality indicators to detect pre-analytical errors in laboratory testing. Clin Biochem Rev. 2012;33(3):85-88.

4.  Naz S, Mumtaz A, Sadaruddin A. Preanalytical Errors and their Impact on Tests in Clinical Laboratory Practice. Pak J Med Res. Published online 2012.

5.  Agrawal L, Engel KB, Greytak SR, Moore HM. Understanding preanalytical variables and their effects on clinical biomarkers of oncology and immunotherapy. Semin Cancer Biol. 2018;52:26-38. doi:10.1016/j.semcancer.2017.12.008

6.  Holland NT, Smith MT, Eskenazi B, Bastaki M. Biological sample collection and processing for molecular epidemiological studies. Mutat Res Mutat Res. 2003;543(3):217-234. doi:10.1016/S1383-5742(02)00090-X

7.  Masucci GV, Cesano A, Hawtin R, et al. Validation of biomarkers to predict response to immunotherapy in cancer: Volume I — pre-analytical and analytical validation. J Immunother Cancer. 2016;4(1):76. doi:10.1186/s40425-016-0178-1

8.  Ntzifa A, Lianidou E. Pre-analytical conditions and implementation of quality control steps in liquid biopsy analysis. Crit Rev Clin Lab Sci. 2023;60(8):573-594. doi:10.1080/10408363.2023.2230290

9.  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

10.       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

11.       Permenter J, Ishwar A, Rounsavall A, et al. Quantitative analysis of genomic DNA degradation in whole blood under various storage conditions for molecular diagnostic testing. Mol Cell Probes. 2015;29(6):449-453. doi:10.1016/j.mcp.2015.07.002

12.       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

13.       Magnette A, Chatelain M, Chatelain B, Ten Cate H, Mullier F. Pre-analytical issues in the haemostasis laboratory: guidance for the clinical laboratories. Thromb J. 2016;14(1):49. doi:10.1186/s12959-016-0123-z

14.       Monach PA. Repeating tests: different roles in research studies and clinical medicine. Biomark Med. 2012;6(5):691-703. doi:10.2217/bmm.12.57

15.       Rimm DL, Han G, Taube JM, et al. A Prospective, Multi-institutional, Pathologist-Based Assessment of 4 Immunohistochemistry Assays for PD-L1 Expression in Non–Small Cell Lung Cancer. JAMA Oncol. 2017;3(8):1051. doi:10.1001/jamaoncol.2017.0013

In this article, we look at how the GIAB can integrate these omics technologies, so that researchers can gain a comprehensive understanding of complex biological systems, unlocking new insights into health, disease, and drug development.

The Value of Multiomics

• Genomics: Studies the entire set of DNA within an organism. It offers foundational insights into genetic variations and predispositions to diseases.
• Transcriptomics: Focuses on RNA transcripts produced by the genome. It sheds light on gene expression patterns and regulatory mechanisms under various conditions.
• Proteomics: Examines the entire set of proteins, including their modifications and interactions. It provides a direct measure of the functional molecules driving cellular processes.
• Metabolomics: Analyzes the complete set of metabolites, which are the end products of cellular processes. It reflects the physiological state of cells in real-time.

Key Benefits of a Multiomics Approach

The integration of these diverse datasets through a multiomics approach yields comprehensive insights that cannot be achieved by any single omics analysis. This holistic perspective enables researchers to:

• Unravel complex disease mechanisms by connecting genetic predispositions with phenotypic outcomes.
• Identify novel biomarkers and therapeutic targets by revealing the underlying molecular pathways.
• Accelerate drug discovery and development by providing a more precise understanding of drug mechanisms and patient responses.

Integrating these perspectives, multiomics provides a holistic view of biological systems. This approach enables researchers to uncover hidden connections, identify biomarkers, elucidate disease mechanisms, and discover novel therapeutic targets. It accelerates research in the discovery and pre-clinical phases, helping biopharmaceutical companies save time and resources by focusing on the most promising drug candidates.

How the GIAB supports Multiomics

At Sampled, we understand the transformative potential of multiomics at the research and discovery/pre-clinical stage. That’s why we offer a wide range of services tailored to support multiomic workflows. From sample collection and processing to sequencing and bioinformatics, we provide end-to-end solutions designed to meet the diverse needs of our clients.­­

Analytical Sample Processing

We offer a suite of analytical sample processing services, including sample aliquoting, DNA/RNA extraction, fractionation, normalization, and sample processing quality control (QC). In our aliquoting workflow, we handle samples received from various sources, ensuring proper storage throughout the handling process.

These critical first steps ensure the integrity and uniformity of biological samples, laying a solid foundation for downstream multiomics analyses. By employing stringent QC protocols, Sampled ensures the reliability and reproducibility of data generated from its repository, which is particularly important for research involved in clinical trials.

Sequencing

Our sequencing services give our clients invaluable insights into their samples, expediting academic, industrial, and clinical research. By partnering with key technology platform manufacturers such as 10X Genomics, Illumina and PacBio, Sampled facilitates a wide range of omics analyses, including whole genome sequencing (WGS), whole exome sequencing (WES), targeted sequencing, Sanger sequencing, RNA sequencing, methylation sequencing, and advanced proteomics.

This complete and comprehensive suite of sequencing services enables researchers to delve deep into the genetic, transcriptomic, and epigenetic landscapes of biological samples, uncovering novel insights into disease mechanisms, biomarker discovery, and personalized medicine.

Proteomics and Protein Biomarker Discovery

Through partnership with Olink, we offer advanced proteomics and analyses through the Explore HT and 3072 platforms, allowing researchers to dissect the functional aspects of biology and uncover novel biomarkers for disease diagnosis and treatment. The Explore HT platform allows levels of over 5400 proteins to be determined from minimal sample volume giving researchers unprecedented access to discover new biomarkers from a wide range of medical fields including but not limited to oncology, cardiology, neurology, inflammation, and diabetes.

Microarrays

Sampled’s GIAB also offers microarray services, including genotyping, transcriptome profiling, and methylation profiling arrays. These high-throughput platforms enable researchers to interrogate genetic, transcriptomic, and epigenomic variations on a genome-wide scale, facilitating the identification of disease-associated biomarkers, therapeutic targets, and molecular signatures. By harnessing the power of microarrays, Sampled empowers researchers to unravel the intricacies of complex diseases and accelerate drug discovery efforts.

Bioinformatics

In addition to its analytical capabilities, Sampled offers comprehensive bioinformatics services, including data analysis and custom reporting tailored to individual client needs. Sampled obtains data from its in-house analytics pipeline or directly from clients. The data is securely stored on the laboratory information management system (LIMS) and can be accessed through SampledSphere. We offer tailor data analysis to meet client-specific requirements, which vary based on sequencing or array types.

Outsourcing multiomics services to Sampled offers numerous benefits, including access to state-of-the-art technologies, expertise, and scalability. Our platforms are designed to streamline sample processing and analytical workflows, reducing turnaround times and maintaining sample integrity throughout the analysis pipeline. This efficiency ensures that you receive your results promptly, allowing you to move forward with your research without unnecessary delays.

In conclusion, the Global Integrated Analytical Biorepository represents a critical advancement in the era of multiomics, offering researchers unprecedented opportunities for discovery and innovation. By providing end-to-end support for multiomics workflows, Sampled empowers researchers to gain a comprehensive understanding of complex biological systems. This holistic approach paves the way for breakthroughs in disease diagnosis, treatment, and prevention, highlighting the benefits of outsourcing multiomics services to accelerate research. For those ready to explore the frontiers of multiomics, Sampled stands ready to guide you through this exciting journey, unlocking the mysteries of life one molecule at a time.

For more information on accelerating your research through outsourcing multiomics workflows, contact Sampled today and speak with one of our experts.

As the world’s only Global Integrated Analytical Biorepository, Sampled are uniquely positioned to ensure sample integrity by minimizing risk to samples. Clients no longer need to risk the integrity of their samples or becoming compromised due to repeated shipment between multiple sites for analysis at third party labs before being sent back into storage. Instead, their samples are stored in the same facility as the one they are analyzed in, ensuring that they are subjected to the same SOPs, storage conditions and limited amount of handling.

Here is how Sampled can aid oncology researchers in the first three key stages of their research by utilizing the Global Integrated Analytical Biorepository.

1. Research and Discovery Stage

Groundbreaking discoveries in oncology all start with the research and discovery stage, where researchers explore potential biomarkers, therapeutic targets, and disease mechanisms in order to exploit them. Outsourcing key services to Sampled can accelerate this stage by:

• Efficient storage and retrieval.

Example: A dedicated sample storage service ensures the preservation of valuable biological specimens. By outsourcing cryogenic storage to our specialized facility with CAP/CLIA accreditation researchers have access to well-preserved samples that are cared for round the clock by a dedicated team of experts working to ISBER best practices.

• Access to High-throughput analysis

Utilizing outsourcing services for transcriptome analysis using microarrays or next generation sequencing enables researchers to examine gene expression at a large scale. This can uncover potential biomarkers and pathways associated with specific cancers, providing a wealth of data for further investigation.

• Gaining comprehensive genomics insights

Outsourcing next-generation sequencing (NGS) allows researchers to delve deep into the genomic landscape of cancers. This can unveil genetic mutations, the epigenetic landscape and potential therapeutic targets that may guide subsequent stages of research.

2. Preclinical Research Stage

After promising leads have been identified, the preclinical research stage aims to validate and optimize potential therapies before moving to clinical trials. Outsourcing services during this stage provides several advantages:

• Cryogenic Storage

Outsourcing cryogenic storage ensures that preclinical samples, including cell lines and animal tissues, are securely stored in facilities equipped with backup power, up-to-date SOPs and trained staff. Our centralized Global Integrated Analytical Biorepository facility minimizes the risk of sample degradation and ensures uniform handling as well as correct documentation and recording for request by governing bodies such as the FDA etc.

• Comparative analysis

Outsourcing next generation sequencing services for comparative genomic and transcriptomic analysis between normal and cancerous tissues helps identify potentially important variations associated with tumor development. This aids in validating potential targets and stratifying patient populations for future clinical trials. Similarly, Sampled can provide access to cutting edge single cell and spatial RNA sequencing platforms to provide a global view of gene expression patterns, aiding in the identification of potential biomarkers at high resolution as well as therapeutic targets.

• Targeted sequencing for validation

Targeted sequencing allows researchers to validate candidate genes identified in the discovery stage efficiently. This stage may involve screening a larger number of samples to confirm the relevance of genomic alterations and assess their potential as therapeutic targets. Sampled can scale our services to meet your needs allowing you to be agile and able to meet shifting deadlines.

3. Clinical Trial Phase

Moving into the clinical trial phases requires meticulous planning, adherence to regulatory standards, and precise execution. Outsourcing critical services can streamline this process and ensure that your research meets the expectations of regulatory bodies.

• CAP/CLIA accredited sample storage

Sampled offers sample storage services that either meet or exceed the industry standards as set out by the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). This ensures compliance with regulatory requirements for clinical trials since our facilities are equipped with scalable storage solutions which can accommodate the increased volume of patient samples while maintaining the necessary levels of quality control.

• Biomarker identification and patient stratification

Utilizing outsourcing services for transcriptome analysis in clinical trials allows for the identification of predictive biomarkers. This information is crucial for stratifying patient populations, optimizing treatment strategies, and improving the overall success rate of the trial.

• Real-time genomic monitoring

Outsourcing real-time sequencing services during clinical trials enables researchers to monitor genomic, epigenetic and transcriptomic changes in patients over the course of the study. This dynamic approach allows for adaptive trial design, optimizing treatment protocols based on evolving insights.

4. Regulatory Review and Approval

The difference between a drug/therapy gaining regulatory approval or being delayed can lie in the details that are involved in the meticulous review process. Here, regulatory bodies such as the FDA require access to a wide range of data from cryostorage temperature logs for samples that were transported between sites to genomic data. If your data is unreliable, inaccurate or does not comply with their rules and regulatory standards it could spell disaster and delay the product’s release.

• Ensuring compliant sample preservation

Outsourcing cryogenic storage to our Global Integrated Analytical Biorepository, ensures samples are stored under regulatory-compliant conditions, facilitating smooth regulatory review processes. This is because our team of experts are trained to follow the latest SOPs that conform to processes laid out by regulatory bodies such as the FDA. Not only will your sample’s integrity be preserved for years to come, but they will also meet the requirements laid out by major regulatory bodies should they be recalled from storage for review.

• Regulatory Compliance Support

Sampled has a proven track record of working with large and smaller biopharmas for  many years and has aided researchers in meeting regulatory requirements for many studies including those based in oncology.

• Generation of high-quality data for regulatory submissions

By outsourcing sequencing requirements to Sampled, researchers can ensure that the genomic data generated for regulatory submissions is accurate, reliable, and complies with regulatory standards.

5. Manufacturing and Scaling Up

• High-throughput analysis for large-scale studies

Outsourcing microarray services to Sampled allows researchers to scale up gene expression profiling efficiently, a critical step in understanding the molecular intricacies of oncology. We have the resources to scale to meet your needs, which removes any need for you to find capital expenditure to purchase new platforms, hire new staff and maintain projects. This means you can focus on the research that matters most and let us do the heavy lifting on your behalf.

• ICH Stability Storage

Sampled are specialists when it comes to providing stability storage services. Our experts have worked in stability storage many years and adhere to ICH guidelines, providing reliable data on the stability of drug candidates and packaging during the manufacturing and scaling-up stages.

• Comprehensive management of sample logistics

Utilizing our lifecycle management services streamlines the handling and tracking of samples, ensuring integrity and compliance throughout the manufacturing process. We have a bespoke kitting and logistics service that is tailored to your needs including those clients who need logistical support that is compliant with regulatory bodies for clinical trials.

6. Post-Market Surveillance

• Data analysis for continuous surveillance

Outsourcing bioinformatics services to Sampled enables researchers to handle vast datasets generated during post-market surveillance efficiently. This aids in identifying trends, potential safety concerns, and optimizing treatment strategies.

• Outsourcing specialized cell-based assays

Sampled also provides cell services including iPSC cell line generation, PBMC isolation and CRISPR gene editing services allowing researchers to conduct in-depth studies on cell behavior during post-market surveillance, contributing valuable insights for ongoing safety assessments.

• Monitoring genomic changes over time

We offer researchers the ability to continue sequencing their samples during post-market surveillance to ensure ongoing monitoring of genomic variations and potential resistance mechanisms, aiding in adapting treatment approaches as needed. The benefits of this are that it provides reliability and accuracy to the data generated as the same platforms, SOPs, methods of investigation have been used to sequence the samples before, during and after the drug has gone to market.

Conlusion: Outsourcing Oncology Research Services to the Global Integrated Analytical Biorepository

In summary, outsourcing services to Sampled offers a myriad of advantages throughout the research pipeline, from the initial stages of discovery to the critical stages of clinical trials. By leveraging specialized expertise and cutting-edge technologies within our Global Integrated Analytical Biorepository, researchers can enhance the efficiency, accuracy, and success of their endeavors, ultimately contributing to the advancement of cancer diagnostics and therapeutics.

To learn more about how our scientists can accelerate your research click here

What is Long Read Sequencing?

Long read sequencing refers to a DNA sequencing technique that generates significantly longer DNA reads compared to traditional short read sequencing methods. The ability to read longer stretches of DNA has numerous benefits, including:

Unraveling Complex Genomic Regions

Long read sequencing is particularly advantageous in deciphering complex genomic regions, such as repetitive sequences or structural variations, where short read sequencing often falls short.

Facilitating De Novo Assembly

The reconstruction of a genome without a reference sequence is greatly improved with long read sequencing. This is especially valuable when studying non-model organisms or those with complex genomes.

Enhancing Transcriptome Analysis

Long read sequencing aids in the accurate identification of alternative splicing events and provides a more comprehensive view of the transcriptome, shedding light on the diversity of RNA isoforms.

What is HiFi Long Read Sequencing:

High Fidelity (HiFi) long read sequencing takes long read sequencing a step further by minimizing errors in the sequencing process. It achieves this by reducing the error rates associated with DNA sequencing, ensuring greater accuracy in the resulting genomic data. PacBio’s Revio is one example of a platform that performs HiFi long read sequencing offering high throughput, and ease of use to a foundation of long reads, exceptional accuracy, and direct methylation detection. The key benefits of HiFi long read sequencing include:

Precision in Variant Calling

HiFi long read sequencing is crucial for accurate identification of single nucleotide polymorphisms (SNPs) and other genetic variations. This precision is especially valuable in clinical genomics and personalized medicine.

Improving Genome Annotation

Higher sequencing accuracy enhances the reliability of genome annotations, ensuring that researchers can confidently interpret and annotate genes, regulatory elements, and other genomic features.

Enabling Rare Variant Detection

The improved accuracy of HiFi long read sequencing allows for the detection of rare genetic variants that may have clinical implications, providing valuable insights into the genetic basis of diseases.

Advantages of Outsourcing High Fidelity Long Read Sequencing

Outsourcing HiFi long read sequencing to specialized service providers offers several advantages for researchers:

Expertise and Experience

Service providers such as Sampled have a team of experts with extensive experience in HiFi long read sequencing, ensuring reliable and high-quality results. Our expertise is at your disposal allowing you to save time and resources on optimization and training staff internally to setup long read sequencing projects.

Access to cutting edge platforms

Outsourcing allows researchers to access cutting-edge sequencing technologies and equipment without the need for significant capital investment, ensuring the use of the latest advancements in the field. Sampled are Certified Service Providers for PacBio and Illumina which allows us to provide high quality HiFi long read sequencing services to our clients since we work with and are trained by the manufacturers of these sequencing platforms.

Cost-Efficiency

By outsourcing, researchers can avoid the costs associated with purchasing and maintaining expensive sequencing equipment. This not only allows researchers to allocate resources more efficiently, focusing on data analysis and interpretation but also shifts capital expenditure to operational expenditure.

Scalability

At Sampled, we can scale to meet your needs based on the research project/s you are running, accommodating for variations in sample sizes and throughput requirements. This lets you focus on the research that matters most instead of shifting deadlines to accommodate the changing of samples that need to be sequenced. Including options for short read sequencing with platforms like the Illumina Novaseq X Series.

HiFi long read sequencing is transforming genomic research, enabling scientists to explore the intricacies of the genome with unprecedented accuracy. As outlined above, outsourcing HiFi long read sequencing to Sampled offers researchers a strategic and cost-effective approach to harnessing this powerful technique, allowing you to focus on the scientific discoveries that will shape the future of genomics.

Contact our team today to learn how we can support your research with our HiFi Long Read Sequencing capabilities.