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

What is Cryogenic Storage?

Cryogenic storage involves storing and maintaining biological samples at ultra-low temperatures, typically within liquid nitrogen cryo-tanks or dewars. Cryogenic storage facilities should maintain stringent conditions to ensure the long-term viability of stored samples. Incorrectly storing or maintaining these samples can lead to irreversible loss of sample integrity and the loss of irreplaceable samples. Typically, a well-maintained storage facility should include:

Cryogenic Temperature tanks/dewars: Samples to be stored at temperatures below -190 degrees Celsius require specialized cryopreservation containers to be housed in. This prevents biological activity, including cell metabolism, and slows down chemical reactions ensuring the samples remain stable.

Controlled Environments: Storage facilities should be equipped with advanced monitoring and control systems to regulate temperature, humidity, and other environmental factors. This precision ensures the samples are kept in optimal conditions for extended periods. Monitoring these conditions is crucial, especially for samples that are part of clinical trials as the temperature log data for the samples will be audited by a regulatory body such as the FDA.

Secure Infrastructure: Cryogenic storage facilities must be designed with robust security measures, including access controls and monitoring systems, to safeguard against unauthorized access and potential hazards. Having the appropriate infrastructure set up, as is seen in the Global Integrated Analytical Biorepository is in line with the latest ISBER Best Practices.

Backup Systems and Disaster Recovery: To mitigate the risk of equipment failure, reputable cryogenic storage providers implement redundant systems and backup protocols in the event of disaster. This ensures the continuity of sample preservation even in the event of technical issues. This is crucial for organizations who are carrying out clinical trial work.

Continuous Monitoring and On-site Technical Services: Advanced monitoring technologies need to be employed to keep a constant check on the condition of stored samples. This includes real-time temperature monitoring, alarms for deviations, and regular system checks to guarantee the integrity of the stored biological materials. If there is an issue on-site technical services can move samples to back-up systems whilst pre-written disaster recovery plans are executed.

Advantages of Outsourcing Cryogenic Storage:

Expertise and Compliance:

Outsourcing to a Global Integrated Analytical Biorepository such as Sampled ensures that your samples are stored in compliance with industry standards and regulations such as CAP/CLIA. We possess the necessary expertise to handle various types of biological materials, reducing the risk of errors and ensuring regulatory compliance.

Cost-Efficiency:

Establishing and maintaining an in-house cryogenic storage facility involves significant upfront costs, including equipment, infrastructure, and personnel training. Outsourcing allows organizations to avoid these expenses and pay for storage services based on their specific needs, leading to cost savings in the long run. Moreover, by saving lab space in your own lab you can focus on the research that matters and reduce your overall footprint.

Focus on Core Competencies:

Outsourcing cryogenic storage enables organizations to focus on their core competencies and research activities. By delegating the responsibility of sample preservation to Sampled, researchers can allocate more time and resources to their primary focus, accelerating innovation and discovery.

Reduced Operational Risks:

Sampled specializes in cryogenic storage as we are equipped to handle the intricacies of sample preservation. By outsourcing sample storage to us, you can reduce the operational risks associated with managing in-house storage facilities. This includes minimizing the risk of equipment failure, sample loss and ensuring data security.

Scalability and Flexibility:

We have the ability to scale to meet your cryogenic storage requirements based on fluctuating research demands. At Sampled we offer customizable storage solutions, allowing researchers to adapt their storage capacity without the need for substantial infrastructure investments.

Outsourcing cryogenic storage is a strategic decision that offers numerous benefits to research organizations that require reliable and secure preservation of biological samples. By entrusting this critical task to us, businesses can leverage expertise, ensure compliance, and focus on their core activities, ultimately advancing research and innovation.

To learn more about how Sampled can support your Cryogenic Storage needs, speak to one of our experts today.

In the UK this was the result of a massive surge in demand by almost a quarter in the first half of 2022¹. This property data raises large concerns about the UK’s ability to capitalize on a surge of interest in its life sciences sector. Research director at Bidwells, Sue Foxley, stated that the shortage is worse than anything she has seen before, with many companies being forced to lease office and other commercial space before refitting them as laboratories:

“The government has grand ambitions to transform Britain into a scientific superpower, but the Oxford-Cambridge arc is at threat of becoming a victim of its own meteoric rise, with the unicorns of tomorrow increasingly being locked out of mission-critical R&D space.” she told the Financial Times².

Rentable spaces can see significant wait lists, rigorous vetting processes and high rent rates that challenge start-ups and research groups that wish to expand rapidly. These factors could slow growth and innovation due to a restriction of access to the right resources and technologies³.

In the long term, greater investment in creating laboratory space and offices is required, however this will take a huge amount of investment from governments and organizations and could take many years to complete. Unfortunately, this solution doesn’t help many laboratory managers who are in desperate need of bench space right now. Where time and overheads are an issue, working with an external service provider could be an effective solution for those looking to move their research projects forwards faster.

With facilities across both the US and UK, as well as partner labs in The Netherlands, China and Australia as well as nearly 25 years’ experience in handling biological samples, Sampled are here to support researchers with a range of services.

Why set up your own lab space? Use Sampled Labs Outsourced Biorepository & Lab Services

• Sample Storage
• Sample Management
• Sample Analysis
• Sample Research
• Sample Transport

As one of the worlds largest biorepositories, Sampled store over 11.5 million samples for researchers worldwide that could mitigate the resources and ongoing the ongoing investment that may be required when setting up your own biobank⁴. From small collections provided in a variety of labware formats through to providing storage for your own freezers/LN₂ tanks on our premises, Sampled has the expertise and flexibility to protect sample integrity and chain of custody documentation. Our facilities are also equipped to mitigate risks from environmental factors and feature redundancies such as back-up generators and Liquid Nitrogen supply back-ups.

Saving on floor space and preserving sample integrity are not the only reasons to consider outsourcing services. The value of the insights gained from your biological samples is also dependent on access to the right technologies, Sampled Labs are set up to provide access to a wide range of technology providers such as; Perkin Elmer, Illumina, ThermoFisher, Standard BioTools and many other leading technologies.

If you have biologic samples you need to Store, Manage, Analyze, Research or Transport, Sampled has the facilities and expertise ready to support you today. Get in touch with one of our experts here.

Sources:

1. Bidwells report: https://www.bidwells.co.uk/what-we-think/arc-market-databook-cambridgeshire-offices-and-labs-summer-2021/
2. Financial Times article- Lab space shortage threatens life science boom in Oxford and Cambridge: https://www.ft.com/content/397a75aa-3047-432e-8664-d1974fbb05df
3. Entrepreneur article- The Shortage of Lab Space in the United States Is Stifling Innovation: https://www.entrepreneur.com/article/424975
4. Frontiers in Medicine Article – Automated Sample Storage in Biobanking to Enhance Translational Research: The Bumpy Road to Implementation: https://www.researchgate.net/publication/338482409_Automated_Sample_Storage_in_Biobanking_to_Enhance_Translational_Research_The_Bumpy_Road_to_Implementation

The cost of the infrastructure and experienced team needed to ensure the safety of precious, often irreplaceable, biospecimens can be prohibitively high. State of the art biostorage systems require significant controlled lab space equipped with remote monitored temperature monitoring systems, backup power, staff trained in the maintenance of biological sample storage equipment at a variety of temperatures and the establishment of documented procedures for disaster recovery. Whether you need to protect your samples for contractual requirements, audit purposes or future research, repositing biological samples in a temperature controlled environment for future access comes with considerations, including the economics of outsourcing. This blog looks at four key challenges when it comes to biological sample storage.

Flexibility – labware format and access are all issues to consider for biological sample storage.

• Labware format: Whether samples are collected as part of a clinical trial, demographic study or other research project it is likely that different labware types will be used – this could be due to legacy sample collections or labware shortages as seen recently. Therefore it is important to retain flexibility in labware when looking at storing biological samples. Professional biorepositories have systems in place to accommodate a multitude of sample container sizes and types, including cryovials, straws and cassettes for blood bags.
• Data Management & Storage: The data you keep with the sample is as important as the sample itself, if either fail then the sample is useless. Many biological sample collections grow from small beginnings where sample records are managed on a homegrown LIMS or on spreadsheets. Researchers must ensure they have robust data and correct access available. Biorepository LIMS systems monitor sample location and status in real-time and have IT and software security measures in place to restrict access to sample data to the client sponsoring biological sample storage.
• On site space: Floor space in research labs can be hard to come by, and in cases where space is limited the competition can be high. Outsourcing the storage of low-touch samples can be a great way of freeing up lab space and creating more space for important research to take place.

Cost – should be considered over the lifetime of biological sample storage.

• Infrastructure & installations costs: there are many important costs to consider when setting up on-site storage including facilities adaptations¹, energy costs, FTE costs and the impact on other departments from a resource point of view.
• Ongoing service costs: Depending on the biological sample stored, and the reasons for the storage a samples lifetime may run into decades and outlive storage facilities which would need to be maintained eventually replaced. An outsourced biological sample storage service provides this maintenance and relieves the burden from the client. Biorepositories benefit from economies of scale with regard to centralized freezer farms, main liquid nitrogen tanks that feed dozens of storage tanks via computer-controlled systems, and teams of staff responsible for maintenance and oversight.
• Time & resource: In cases where time is an issue, centralized repositories employ dedicated sample management instruments and teams for sample withdrawal and distribution employing cold-chain logistics. This allows for rapid turnover of sample distribution requests upon receipt.

Disaster recovery – ensuring your samples are protected from natural disaster is vital

• Storage location: where your storage is geographically located can be key in the event of a natural disaster. Ensuring your samples are not at risk in areas vulnerable to flooding or seismic activity can be overlooked if sample collections have evolved in a site not designed specifically for that purpose.
• Backup generators: building in redundancies (diesel and natural gas generator fuel sources, for example) and back-up generators is an important element to ensure samples are protected in case of a power-failure or liquid nitrogen supply failure. Also ensuring that back-up generators are not located in areas vulnerable to flooding is important e.g. in basement areas. Installation and maintenance of these systems can be a costly part of on-site storage.
• Redundancies and Monitoring: it is vital to have constant temperature monitoring in place with alarm systems and redundant freezers available in case of emergency should a system go down for any reason, including human error which has been seen in multiple examples such as a tragic case in which 25 years of research lost due to a system being turned off by a custodian.
• On-Call Service Technicians: Having immediate availability of service technicians allows for both fast response and continuous testing and preventitive maintainance, helping mitigate the risks of a catastrophic failure.

Storage Temperature – understanding what temperature your samples need to be stored at

• -20°C Sample Storage: Commonly available in both mechanical upright (manual) freezers as well as automated systems to speed up storage and retrieval, often seen in high throughput screening labs. Typically we recommend DNA/RNA samples are stored at –80°C degrees Celsius.
• -80°C Sample Storage: Again, commonly available in both mechanical upright (manual) and automated systems. Typically we recommend this for long term storage of biological samples such as proteins or nucleic acids.
• -190°C Sample Storage: also described as vapor phase LN2 or liquid phase LN2, -190°C biological sample storage can be the best option for storing tissue samples or cells suspended in a cryopreservation agent (CPA). These samples could include blood or tissue as well as other sample types such as reproductive specimens. 

Summary

Biological sample storage can be done in-house with the installation and ongoing maintenance of dedicated storage systems (of which there are many on the market to choose from), along with the above considerations such as; labware format, installation costs, storage location and variety of storage temperatures available.

Alternatively, researchers can outsource their storage needs to an external sample storage provider such as Sampled, and trust the 20+ years of experience we have in storing millions of biosamples and and ISBER Gold Member in our custom storage facilities that are ready to go with no waiting time. Sampled outsourced sample storage includes consultation with our clients to ensure a sample storage solution is not just tailored to protect your biological sample integrity but easy to access and flexible enough for different sample types and labware formats. This means that we manage the samples but our clients retain access to the storage environment, access, format and data relating to their biological samples.

With over 20 years operating as a biorepository storing millions of biosamples and global distribution capabilities, Sampled is proud to work with a wide variety of clients from hospitals to academic research institutions as well as large pharma. If you have biologic samples you need to store, Sampled has the facilities and expertise ready to support your biological sample storage today.

Get in touch with one of our experts today

References:

1: Facilities costs for sample storage https://www.researchgate.net/publication/338482409_Automated_Sample_Storage_in_Biobanking_to_Enhance_Translational_Research_The_Bumpy_Road_to_Implementation