At Sampled, we specialize in providing high-quality NGS services to researchers across the globe. Our team of experts has extensive experience in designing experiments, optimizing protocols, and interpreting results, ensuring that the data generated is of high quality and relevance to the research question. In this article, we will explore 7 key benefits of outsourcing NGS services.

Access to Expertise

NGS is a highly specialized field where the technology is constantly evolving, and keeping up with the latest developments can be challenging. Here at Sampled, our highly skilled experts have years of experience in this field and have the necessary expertise and knowledge to deliver high quality and accurate results. Furthermore, our team stay up to date with the latest advancements in the field by working with sequencing partners closely. We will work with you to help design experiments, optimize protocols, and interpret your results if you require access to a Bioinformatics team. This expertise can help ensure that the data generated is of high quality and relevant to the researchers’ aims and objectives.

Cost-Effectiveness

The cost of setting up an in-house NGS facility can be prohibitive for many research organizations. Not only does it require the purchase of expensive equipment, but also ongoing maintenance, upgrades, and personnel costs. Outsourcing NGS services can be a cost-effective alternative. Sampled can provide customized service packages that fit within your budget, without compromising on quality or turnaround time. This means that sequencing costs can be reduced, allowing researchers to allocate more resources to other areas of their research.

High-Quality Data

The quality of the data generated by NGS can vary depending on several factors, including sample preparation, sequencing platform, and bioinformatics analysis. A specialized NGS provider, like Sampled, can ensure that each step of the process is optimized for quality. We use state-of-the-art equipment, standardized protocols, and rigorous quality control measures to ensure that the data generated is accurate and reliable.

Faster Turnaround Time

NGS can be a time-consuming process, with each step taking several days to weeks to complete. Outsourcing NGS services can help accelerate the research timeline. At Sampled our team of experts work quickly and efficiently, without compromising on quality. We can provide fast turnaround times, allowing researchers to get their results faster and move on to the next stage of their research. This can be critical in situations where time is of the essence, such as when studying outbreaks of diseases or if demand surges due to unforeseen circumstances.

Customized Service Packages

Every research project is unique, and NGS service providers should be able to provide customized service packages that meet the specific needs of each project. Sampled offers a wide range of services, from whole-genome sequencing to targeted sequencing to transcriptomics. This includes options such as the choice of the sequencing platform to be used, the number of reads, and the level of coverage. We can work with researchers to design experiments that fit their research question and budget. We also provide flexible service options, such as pilot studies and data analysis only, to help researchers get the most out of your NGS data.

Reduced Risk of Errors

NGS involves multiple complex steps, from sample preparation to bioinformatics analysis, and each step has the potential for errors. Outsourcing NGS services to Sampled can help reduce the risk of errors. We have extensive experience in handling different types of samples, optimizing protocols, and troubleshooting technical issues. Moreover, we have stringent quality control measures in place to ensure that errors are identified and corrected.

Scalability

Research projects can vary in size and scope, and NGS service providers should be able to scale their services accordingly. Because we invest in multiple platforms, Sampled has the capacity to handle large-scale projects, with the ability to process thousands of samples per month. We can also work with researchers to develop customized workflows that can be scaled up or down depending on the project’s needs. Altogether, this means that researchers can scale their projects without having to invest in expensive equipment or hire additional staff.

What NGS Services Does Sampled Provide?

Sampled provides a wide range of NGS services using leading technologies such as Illumina, PacBio, and Twist Biosciences:

• Whole Genome Sequencing
• Whole Exome Sequencing
• Amplicon Sequencing
• Whole Transcriptome Sequencing
• mRNA Sequencing
• 10X Genomics Single Cell gene expression
• Storage and transportation of single cells
• Metagenomic Sequencing
• PacBio Long Read sequencing
• Custom panel design and sequencing

In conclusion, outsourcing NGS services to Sampled enables access to expertise, cost-effectiveness, high-quality data, faster turnaround times, customized service packages, reduced risk of errors, and scalability. Our team of experts can work with you to design experiments that fit your research question and budget and deliver high-quality results that help you to advance your research. Contact us today to learn more about our NGS services and how we can help you to achieve your research goals.

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

With a rich legacy spanning over two decades, Sampled, the driving force behind the FIALB, presents a paradigm shift in biobanking, aiming to optimize biospecimen quality and accelerate health innovations.

A Unified Approach to Precision Medicine

Traditionally, biorepositories have served as custodians of precious samples, ensuring their proper storage and accessibility. However, the demands of modern research, characterized by the need for speed and high-throughput multiomics analysis, call for a new approach. Our FIALB pioneers this evolution by integrating every aspect of the biospecimen life cycle, from collection to storage, processing, and analysis.

The FIALB achieves this through rigorous oversight of the quality of each process with strict adherence to Standard Operating Procedures (SOPs) and Technical Training Programs. To this end, innovative approaches are required to establish standards of quality for each process, including assembly of sample collection kits, well defined sample registration and accessioning processes that integrate seamlessly with a Laboratory Information Management System (LIMS), the extensive use of automated systems, novel analytical and functional assays of nucleic acid quality prior to genomic analysis. Thus, the FIALB places the biorepository at the heart of an analytical laboratory environment featuring advanced omics systems for generating clinically actionable data, interpretation, and translational results.

Components of the FIALB Ecosystem

• Scale: Centralized capacity enables to accommodate millions of samples efficiently, eliminating the need for scattered storage solutions.

• Quality and Reproducibility: Rigorous quality control processes ensure sample integrity and reliable downstream testing, instilling trust in research outcomes.

• Globalization: Standardized sample collection logistics facilitate international studies, fostering consistency and elevating data quality.

• Integrated Capabilities: FIALB transcends traditional biorepositories by offering a comprehensive ecosystem of research support services, including multi-omics analysis, cellular services, and logistics.

• Diversity and Longevity: Embracing diversity in sample collections ensures inclusivity in health innovations, addressing historical inequities.

• Commercial Availability: Beyond storage, FIALB serves as a biobank, fostering collaborative research by providing seamless sample access and infrastructure support.

Empowering Precision Medicine Development

In the pursuit of precision medicine, speed and accessibility are paramount. The FIALB not only facilitates the incorporation of cutting-edge technologies like single-cell RNA sequencing but also provides a scalable platform for diverse research needs. By offering integrated, technology-agnostic facilities and services, FIALB accelerates the translation of research findings into tangible treatments.

Ensuring Accessibility and Utilization

Merely storing samples is no longer enough, they must be readily available for research. The FIALB addresses this challenge through its proprietary platform, SampledSphere, which streamlines sample management and retrieval, ensuring maximum utilization of stored samples and associated data.

Shaping the Future of Health Research

As we stand on the cusp of a new era in health research, FIALB emerges as a transformative force, ushering in unprecedented opportunities for breakthroughs in precision and personalized medicine. By embracing innovation, collaboration, and inclusivity, FIALB paves the way for a healthier, more vibrant world.

In essence, the Fully Integrated Analytical Laboratory and Biorepository represents not just a facility but a vision—a vision of pushing the boundaries of science to create a future where every individual receives tailored healthcare solutions, bringing us one step closer to a healthier tomorrow.

Learn more about how our FIALB can accelerate your research today here

Avoiding Interuptions in Stability Storage Studies with Disaster Recovery

The importance of having a tried and tested disaster recovery plan in place for your stability storage studies cannot be overstated. Pharmaceutical and Medical Device industries rely on stability storage studies to gain regulatory approval for product launch. Any disruption in the stability studies due to an unforeseen incident would lead to significant delays in the company gaining regulatory approval, being able to launch the product and ultimately impacting the businesses bottom line.

Ensuring Business Continuity

Stability storage trials can last from between 6 months and over 5 years, this is a huge window of opportunity for something to go wrong in, therefore having a backup plan in place is a necessity. One effective way to ensure business continuity is to dual run your stability storage studies by sending extra samples to an outsource provider, this way if your primary stability study is compromised due to unforeseen events the secondary set of samples can still be used to continue your testing schedule, saving you from starting over.

A second option to consider is to outsource your stability storage studies in totality, in doing so researchers can ensure that samples are stored in a secure, regulated, off-site facility which is equipped with backup power, redundant systems, trained and knowledgeable staff as well as comprehensive disaster recovery plans. Providers of outsourced stability storage services can leverage their facilities to provide further risk mitigation by splitting the product over multiple chambers and locations on or off site. Outsourced providers also possess the advantage of using the latest compliant technology to monitor samples in real-time, manage inventory, and provide clients with detailed data reports at regular intervals.

Thus, should a laboratory/manufacturer suffer an unforeseen disaster and the stability storage samples become compromised, there would be minimal impact on the company’s revenue, quality, or studies as there are samples and safely stored with the outsourced provider.

Sampled is Your Disaster Recovery Partner

Sampled are experts in sample storage and especially in conducting outsourced stability storage trials on behalf of our clients and helping to de-risk this aspect. We not only have the facilities, space, staff and expertise to be able to store your samples in our ICH validated chambers but also a wealth of experience dealing with disasters when they happen. Sampled are here for you should the worst happen and your storage suite becomes compromised. Our staff are on-call 24/7/365 and ready to respond and accept your samples should you need to transport them to us for storage if your labs become compromised. Our team of experts can adopt your protocols to ensure that the samples you send to us are stored in the same conditions as before so you can continue your stability storage trials and be rest assured on minimal impact.

In conclusion, disaster recovery is not only a critical component of stability storage but also a MHRA requirement that cannot be overlooked. Businesses that rely on stability storage for the development and manufacturing of their products must ensure that their samples are preserved and that their operations can recover in the event of an interruption. Outsourcing stability storage can provide businesses with the peace of mind that their samples are secure and that they can maintain business continuity even in the event of a laboratory disaster or shutdown.

If you would like to learn more about how Sampled can become part of your business continuity plan or disaster recovery procedure, talk to one of our experts today.

Due to the complexity of clinical trials, high performance partnerships are paramount. The crucial role of Clinical Research Organizations (CROs) and sponsors is well established, but an underutilized relationship exists with specialist lab services. Picture a triangle, where each corner represents a pivotal partner in this relationship: the CRO, Lab Services, and Sponsor. How each partner approaches this relationship dictates the success not just of the working relationship from a logistics standpoint, but more importantly can influence the success of the trial itself.

Traditional Model: CROs & Sponsors

Traditionally the relationship between CROs and sponsors was a straightforward bilateral partnership. The CRO, with its expertise and infrastructure, would support sponsors in the design, management, and oversight of clinical trials. Whereas the Sponsor would define the requirements and scope as the product owner and financier.

Triangulating Success: Leveraging Lab Services Partners

Bringing a lab services partner such as Sampled on board can play an essential role in ensuring the integrity, reliability, and accuracy of clinical trial data. The results produced by our laboratories have a huge impact on the ultimate success of a trial. Let’s look at how this relationship adds value to both CROs and Sponsors whilst protecting the trusted relationships CROs hold with Sponsors.

Esoteric Testing with Lab Services: Whilst many CROs are capable of routine testing, there is often a need to outsource more esoteric testing to a lab services partner with access to a broad range of leading edge multiomics technologies, what is classified as esoteric testing for most CRO’s is the core competency of specialized multiomic lab services provides that work closely with the tools providers for early adoption of new technology platforms.

CRO-Lab Services Synergy: By collaborating closely with lab services, CROs ensure that the trial’s protocols are meticulously followed, and data is collected and analyzed to the high standards set by regulatory bodies and the sponsor. This partnership allows the CRO to focus on quality assurance and regulatory compliance opposed to sample logistics and testing.

Reduced Burden on Sponsors: The primary relationship sponsors maintain is with the CRO. With lab services directly aligned with CROs, sponsors can rest easy, knowing that a cohesive unit is working to meet their objectives, without having to micromanage each component – only dealing with the lab services partner on specific esoteric testing requirements.

Secondary Channels of Communication: The secondary relationship each party holds with one another (CROs with sponsors, lab services with sponsors, and CROs with lab services) ensures there are direct lines of communication on specific issues like esoteric testing requirements. These communication channels ensure primary relationships are maintained whilst still enabling clear communication.

Benefits of the Triangular Dynamics:

• Efficiency: Streamlined communication between the three entities reduces lag and expedites processes.
• Flexibility: With three informed stakeholders, adaptability to unexpected challenges becomes easier.
• Quality Control: With specialized entities focusing on their core competencies, the likelihood of errors diminishes.
• Holistic Approach: The combined insights of CROs, lab services, and sponsors ensure a comprehensive view of the trial, from design to results.
• Availability of comprehensive multiomic platforms with standard and custom assay design.
• Integration of Biorepository, Analytic services and sample processing.

Conclusion:

Triangulating success in clinical trials – CROs, lab services, and sponsors – this amounts to more than three organizations operating in parallel towards the same goal. It is a high-performance partnership between specialist organizations working as a team towards executing a successful clinical trial. This partnership maximizes efficiency, ensures quality, and fosters innovation. As the world of clinical research continues to evolve, triangulating these relationships should be the cornerstone of success for sponsors and the broader scientific research community.

To learn more about how we can partner with CROs, speak to our team of experts today.

However, when it comes to stability storage, companies face a choice between outsourcing the service or setting up their own internal stability storage facility which can come with large capital expenditure costs. In this article we will cover the benefits and challenges of both options.

Cost of setting up the facility

One of the most significant differences between outsourcing stability storage and setting up your own facility is the cost. Unsurprisingly, setting up an in-house stability storage facility requires considerable capital expenditure as well as running costs. Companies need to buy equipment such as environmental chambers, power backup systems, and monitoring systems. Moreover, there are increased variable and fixed costs due to these investments.

Beyond the large upfront capital expenditure (Capex) required to buy the necessary assets, there is the cost associated with either hiring or training staff to run the stability storage facility and initial/ongoing maintenance and qualifications as well. If your free lab space is limited, setting up a stability storage facility may not be the answer, especially if you have large or a high number of samples and products that require testing. This consideration should not be taken lightly if your labs are based in a city where the cost per square foot is high.

On the other hand, outsourcing stability storage allows companies to avoid the large upfront CapEx associated with setting up and maintaining an in-house facility. Outsourcing providers already have the necessary equipment and infrastructure in place, and clients can often use the facilities on a per-project basis, making it more cost-effective. Outsourcing can also provide a layer of flexibility that in-house operations may not.

Training and Expertise

Setting up your own facility requires specialized skills and knowledge which your staff will not possess unless they come from a stability storage background. Therefore, research groups will have to heavily invest in hiring or training staff with expertise in validation, calibration, and equipment maintenance. Additionally, they will need to have an in-depth understanding of regulations, standards, and best practices for stability storage as laid out in The international Council for Harmonization of Technical Requirements for Pharmaceutical Use (ICH) guidelines.

Outsourcing stability storage can remove these issues since providers are already highly experienced in this area and have trained experts to manage your precious samples.  This expertise can help clients avoid regulatory compliance issues, technical problems, and remove human errors that can ultimately lead to product failures, recalls, and loss of reputation. Similarly, by outsourcing your stability storage you gain peace of mind by knowing your samples are going to be stored in the correct manner according to best practices and guidelines laid out by ICH. Rather than becoming experts in stability storage yourself, you can focus on the research that matters most to you.

Scalability

Another significant difference is the ability to scale your stability storage requirements. Outsourcing this as a service provides the flexibility to match capacity and resources with needs with minimal delay. This is because providers have enough stability chambers, experts and space in-house that they can scale up as your research does. Companies can increase or decrease stability storage capacity as their pipelines expand or contract, without investing more money in equipment or space which saves on capex and ensures deadlines do not need to be extended.

In contrast, an in-house model has limited scalability potential since companies need to invest in equipment and infrastructure to keep up with demand. They may also find themselves with excess capacity during low use periods, leading to operational inefficiencies and additional costs. This is especially a concern for labs based in cities where the cost per square foot is high. 

In conclusion, outsourcing stability storage provides many advantages over setting up your own facility, especially in terms of cost, training and expertise, and scalability. Researchers should always ensure that their stability storage meets the highest quality standards and conforms to industry regulations and guidelines.

Outsourcing stability storage to Sampled

At Sampled we have decades of experience in stability storage and a 30,000 sq ft MHRA cGMP licensed facility based in Glasgow, UK where thousands of samples are stored and managed every year.

Our highly trained experts work with clients to safely and correctly store samples in accordance to cGMP and the guidelines and best practices laid out in ICH.

Our facilities can store a huge variety of products including (but not limited to):

• Pharmaceutical samples
• Clinical trial material
• Bulk pharmaceutical chemicals
• Cosmetics
• Nutraceuticals
• Vaccines
• Medical devices
• Animal health

By outsourcing stability storage to Sampled, you could save on CapEx, lab space and focus on the research that matters most to your group instead of becoming experts in stability storage. Reach out to our team today to discuss your project.

Table of Contents

Challenges in proteomics

In the past several decades researchers have had to rely on mass spectrometry-based techniques to quantify and identify the proteins involved in their samples. These techniques were low throughput however and often required difficult protocol optimizations and time-consuming data analysis pipelines. While useful, these techniques were inadequately slow and required a lot of “hands on” time from researchers. It wouldn’t be long before a new approach to studying proteomics was discovered, using protein chips or microarrays researchers were able to facilitate large-scale, high-throughput proteomic studies. Despite aiding in the advancement of the field, analyzing the data and delineating protein concentrations and interactions from large-scale datasets remained challenging.

A new method of studying protein interactions

Olink’s Proximity Extension Assay (PEA) technology is a new method of quantifying and identifying proteins of interest in complex samples such as blood serum or plasma. Olink platforms such as the Explore HT® and Explore 3072® uses PCR amplification of DNA tags unique to each target protein in proportion to the abundance of the target proteins in the sample: First, two antibodies that carry complementary oligonucleotides (acting as unique barcodes for each antibody) bind to different parts of the target protein must be brought close to each other on the target protein (see Figure 1).

When successful PCR amplification of a DNA tag for the antibody target protein occurs, quantitative PCR reports it as a proxy for the abundance of the target protein (see Figure 2). 

Finally, a short-read Next Generation Sequencing (NGS) platform is used to measure the abundance of the target protein by measuring the proportion of the DNA tags present after PCR (see Figure 3).

With this novel approach to biomarker discovery, researchers are now able to utilize Olink’s HT and 3072 kits in combination with liquid handling and short read sequencing platforms to identify/quantify low abundance proteins with high specificity and accuracy in serum or plasma samples.

A new approach to biomarker discovery

The first step in the workflow involves selecting either the Olink HT or 3072 kit to measure over 5300+ proteins or 3000 proteins, respectively, across 10 orders of magnitude in protein concentrations. Here, Olink’s industry-leading specificity is founded on PEA technology (me, which generates signals only when two matched oligonucleotide-tagged antibodies bind to their intended target protein and generate a correctly hybridized DNA template for readout, eliminating false positives and ensuring data accuracy.

Explore HT workflow

• Sample Preparation & Dilution using liquid handling platforms such as those manufactured by Hamilton and the Mosquito/Dragonfly platforms by SPT Labtech
• Sample incubation prior to PCR step with the Mosquito liquid handling platform
• PCR sets up with Mosquito and Dragonfly, and PCR pooling steps using Sciclone G3 NGSx liquid handling platforms.
• A manual library purification step along with Quality Control
• The NGS libraries are then sequenced on Illumina’s NovaSeq 6000 short read sequencing platform
• Data analysis of results using Olink’s proprietary analysis software. Automation reduces manual steps, while excluding data points that don’t meet criteria before normalization. Moreover, the software effectively identifies the underlying causes of any issues, pinpointing technical and human errors.
  • Olink Pre-Process software ngs2counts
  • Olink NPX Explore HT Software

Explore 3072 workflow

• Sample Preparation & Dilution using liquid handling platforms such as those manufactured by Hamilton and the Mosquito/Dragonfly platforms by SPT Labtech
• Incubation preparation with the Mosquito platform
• PCR 1 sets up with Dragonfly, PCR 1 pooling and PCR 2 sets up, pooling steps with Sciclone G3 NGSx platforms
• Manual Library Purification steps along with Quality Control
• The NGS libraries are then sequenced on Illumina’s NovaSeq 6000 short read sequencing platform
• Data analysis of results using Olink’s proprietary analysis software. Automation reduces manual steps, while excluding data points that don’t meet criteria before normalization. Moreover, the software effectively identifies the underlying causes of any issues, pinpointing technical and human errors.
  • Olink Pre-Process software ngs2counts
  • Olink NPX Explore Software

Overcoming the challenges in high-throughput biomarker discovery

Olink’s Explore HT and 3072 kits are just one part of the biomarker discovery process, as shown in the workflow above, liquid handling platforms such as SPT Labtech’s Dragonfly instruments are also necessary in order to accurately add dilutant and PCR master mix. Briefly, the Dragonfly platform harnesses innovative positive displacement technology to enable accurate and repeatable nanoliter to milliliter dispensing, every time to ensure accuracy and repeatability. While the Mosquito dilutes samples and adds assay reagents for both Olink kits. The Mosquito also utilizes positive displacement pipetting solutions and combines this with the power of miniaturization and automation to reduce costs, improve productivity, and maximize research output.

Once the PCR step has concluded and the NGS libraries are prepared, the library can be sequenced using Illumina’s NovaSeq 6000 platform. The NovaSeq 6000 is a powerful sequencer that can generate massive amounts of short-read sequencing data in a short period of time. The sequencing data is processed using bioinformatics tools to align the reads to a reference genome, identify single-nucleotide polymorphisms (SNPs) and quantify gene expression levels.

Finally, trained experts are then able to take the raw data taken from the NovaSeq 6000 platform and normalize it using Olink’s proprietary software to yield “Normalized protein expression” values or NPX.

In conclusion, the Olink Explore HT/3072 kits, SPT Labtech liquid handling along with Hamilton and  Sciclone G3 NGSx platforms and Illumina’s NovaSeq 6000 platform provide a comprehensive workflow for high-throughput biomarker discovery. This workflow enables researchers to quickly and accurately identify potential biomarkers that can be used for diagnostic or therapeutic purposes. However, purchasing, maintaining, and training staff to run these platforms is highly expensive and time consuming.

Outsourcing biomarker discovery to Sampled

There is an alternative to purchasing these platforms and kits. Outsourcing your samples for high throughput biomarker discovery to Sampled allows researchers to save on capital expenditure since you no longer need to invest in platforms, consumables, and reagents for each step in this workflow outlines above. Furthermore, outsourcing removes the need to train staff on new platforms and time-consuming optimization steps required for each step of the workflow. Our trained experts have been trained by each of these manufacturers allowing us to provide industry-leading turnaround time and accuracy.

Speak to one of our experts today to learn more about how our Protein Biomarker Discovery workflow can accelerate your research.

Sampled is now an Olink Service Provider

Piscataway, NJ, August 18th, 2023 – Sampled¹,The Global Integrated Analytical Biorepository, today announced that it has been named a Service Provider for Olink® Proteomics, a leader in Proteomics technology. As a service provider of Olink® Explore technology, Sampled now offers high throughput proteomics services for precise protein biomarker discovery.

The Olink Explore platform represents the cutting edge in highly specific and scalable proteomic technology. Built upon the proprietary Proximity Extension Assay (PEA) that combines high throughput, high-quality protein-level measurements, the platform delivers powerful capabilities for uncovering actionable insights that are key to achieving breakthroughs in disease prevention, diagnosis, and treatment.

Sampled will offer services on two Olink Explore platforms: Olink® Explore 3072 and the newly launched Olink® Explore HT. The Olink Explore 3072 can analyze ~3,000 human proteins and concurrently process up to 352 samples with 32 controls. Olink Explore HT enables specific measurement of over 5,300 protein biomarkers using only 2 µL of sample, while increasing sample throughput by 4X and data output by 7X.

The introduction of the Olink Explore HT software simplifies data analysis and streamlines quality control, accelerating the extraction of actionable biological insights. These advancements complement the already comprehensive multi-omics lab services.

“Combining Olink Proteomics with our impressive biorepository capabilities enables not only specific insights on a sample level, but insights that are improved by the statistical power, enhanced reliability and better representation gained through larger, more diverse studies.” Shareef Nahas, PhD, Chief Scientific Officer, Sampled.

“We are excited to have Sampled as a service provider of our leading Olink Proteomics platform. Sampled’s mission of delivering superior biobanking to empower transformative health innovation, aligns perfectly with Olink’s goal of creating the most powerful solutions for scientific research,” said Michael Irwin, Vice President, Sales and Marketing, Olink. “With the adoption of the Explore HT platform, Sampled can now offer their customers a very unique high-throughput proteomics offering.”

“With this partnership, Sampled furthers its mission to empower researchers with innovative tools for understanding human biology and accelerating the future of healthcare and partnering with our clients to move health innovations forward, faster.” Said Robin Grimwood, Chief Executive Officer, Sampled.

About Sampled

Sampled is a next-generation laboratory that unlocks the valuable data in any biological sample. Through our integrated lab services, we can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Our vision is a world where we make it faster and easier for health innovators to improve human health, with a mission for Sampled Labs to be behind every transformative health innovation. Sampled is headquartered in Piscataway, N.J. with labs across the US and Europe and partner labs in the Netherlands, China and Australia.

Infinity BiologiX LLC, Roylance Stability Storage Limited and Roylance Scientific Limited are doing business as Sampled. For more information, please visit www.sampled.com

In this discussion, Product Marketing Manager, Haris Choudhery, PhD met with Stability Storage expert Wendy Cullen, to discuss the importance of photostability testing and its importance in ensuring stability of drug product and packaging.

HC: What is photostability testing?

WC: As the name implies, photostability testing is a type of stress test used on new drug substances and products to measure if they are affected by exposure to light. ICH Q1B guidelines recommend stress testing all drug product and packaging.

To meet these guidelines, photostability testing studies should cover:

1. Tests on the drug substance
2. Tests on the exposed drug product outside of the immediate pack
3. Tests on the drug product in the immediate pack (e.g. blister pack)
4. Tests on the drug product in the marketing pack. (e.g. card-based box)

The photostability testing itself is straightforward, the drug substance and immediate pack are exposed to the same amount of light and temperature in different positions (e.g., topside up, or upside down). Simultaneously, a “dark control” which is the same drug substance wrapped in a non-permeable material such as aluminum foil, is also exposed to the same level of light exposure and temperature. This way the effect of light exposure on the drug product can be measured against the dark control which has been shielded from the light.

In terms of light exposure, the ICH Q1B guidelines offer two options

• Any light source that is designed to produce an output similar to the D65/ID65 emission standard such as an artificial daylight fluorescent lamp combining visible and ultraviolet (UV) outputs, xenon, or metal halide lamp.  D65 is the internationally recognized standard for outdoor daylight as defined in ISO 10977 (1993).  ID65 is the equivalent indoor indirect daylight standard. For a light source emitting significant radiation below 320 nm, an appropriate filter(s) may be fitted to eliminate such radiation.
• The same sample should be exposed to both a cool white fluorescent and near ultraviolet lamp. The cool white, fluorescent lamp is designed to produce an output similar to that specified in ISO 10977(1993). The near UV fluorescent lamp should have a spectral distribution from 320 nm to 400 nm with a maximum energy emission between 350 nm and 370 nm; a significant proportion of UV should be in both bands of 320 to 360 nm and 360 to 400 nm. 

At Sampled, we choose to test our clients’ samples with the second option as it offers them a faster turnaround time which in turn helps them meet their own internal deadlines.

HC: Why is it necessary to conduct photostability testing?

WC: Light radiation is all around us, it’s inescapable and therefore the prolonged exposure of light on both the drug product and the immediate pack surrounding it need to be tested. If you have a drug product that contains compounds that can be altered by the excitation of light radiation, your drug product will inevitably change. This change could lead to several different outcomes from a reduction in efficacy to potentially becoming inactive or even harmful for the patient.

This is why our studies on drug products are carried out in a sequential manner starting with testing the fully exposed drug product then progressing as necessary to the product in the immediate pack and then if required in the marketing pack. 

At the end of each exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity, or color of solution). Where solid drug substance samples are involved, sampling should ensure that a representative portion is used in individual tests.  Similar sampling considerations, such as homogenization of the entire sample, apply to other materials that may not be homogeneous after exposure.  The analysis of the exposed sample should be performed concomitantly with that of any protected samples used as dark controls if these are used in the test.  

If, for example, the drug product is light sensitive, then testing should progress until the results demonstrate that the drug product is adequately protected from exposure to light.

HC: What equipment is required for photostability testing, how easy is it to set up photostability testing in your own lab?

WC: You’ll need to purchase a Photostability chamber which costs between $20-80,000 usually, on top of this there will need to be an annual service contract to replace the special bulbs every 3 years too. The light sensors within the chamber need to be calibrated every two years as well to ensure that they are still giving homogenous coverage over the samples. On top of this there is also the validation contract that has to be acquired too.

Once you have the photostability chamber and contracts in place, you’ll then need to either hire or train staff members to operate it properly. Standard operating procedures, work instructions and all the associated costs that go into training or hiring staff can start to mount up before you realize it. So, if you’re a small pharmaceutical company with one or two drug products then this is a lot of money and effort for equipment that is only used once or twice.

HC: What are the advantages of outsourcing photostability testing?

The most obvious one is the reduction in costs since you don’t need to purchase any specialized equipment and you don’t need to hire and train staff to become experts in photostability testing. Instead, you could send your samples to a service provider, like Sampled, and we can run the photostability testing for you.

Another benefit is that we have the expertise and experience which you may not have. Our in-house experts have many years of experience in conducting photostability testing and can work with you to test your samples and answer your questions and give you peace of mind.

And finally, we can offer you reduced turnaround times. Instead of purchasing, installing, and validating your photostability chamber and then hiring/training staff to operate the chamber, you can simply send your samples to us. We test your samples for you in a fraction of the time that it would take if you tried to do it yourself.  

If you would like to learn more about photostability testing, please contact one of our experts here.

1. Cost-efficiency

Outsourcing this service can save time and money. The cost of setting up facilities can be high, due to the need for purchasing specialized equipment, reagents, and hiring staff. Outsourcing allows companies to access specialized expertise and equipment without incurring the additional costs associated with expanding their facilities or workforce. Additionally, an external provider can conduct the extraction process in a timely and efficient manner, removing any delays and batch failures, in turn reducing expenditure on repeat extractions.

2. Working with experts

RNA extraction requires expertise in molecular biology techniques, such as PCR, qPCR, and RT-PCR. Outsourcing to a reputable provider such as Sampled ensures that the extraction process is conducted by experienced professionals with specialized knowledge in the field. One of the most common mistakes that leads to failed RNA extraction attempts involves incorrect techniques being employed which lead to contamination of RNases. RNAses, as the name suggests, are enzymes that catalyze the breakdown of RNA and are found almost everywhere, including within labs. Our experts are well-versed in RNA extraction best practices and protocols, as a result, clients will receive high quality RNA that will allow for reliable and reproducible data to be generated for their downstream experiments.

3. Scalability

The speed of scalability of RNA extraction services can be limited by the capacity of the in-house facilities. Outsourcing ensures that the RNA extraction services are scalable, and additional resources can be quickly allocated to accommodate new projects. This is beneficial for organizations that need to increase their RNA extraction capacity to meet an increased demand for their products or services. At Sampled we work with clients to ensure that their needs are fully met, we are able to work with you to increase or decrease RNA extraction so that you can focus on more pressing aspects of your research.

4. Avoiding experimental bias

Outsourcing RNA extraction eliminates the potential for experimental bias. Researchers may unintentionally introduce experimental error due to improper handling of the samples, inconsistent procedures, or operator bias. Outsourcing RNA extraction to an external provider ensures that the extraction process is conducted in an unbiased manner, following established protocols and guidelines.

5. Quality control

Sampled prides itself on being a “One-stop-shop” for nucleic acid extraction and testing needs for blood, plasma and saliva samples. Our success rate for nucleic acid sample extraction exceeds 99%. This is in part thanks to our state of the art, quality control provision which includes fully automated and on-demand GLP and CLIA certified services.

In conclusion, outsourcing RNA extraction services has numerous advantages, including cost-efficiency, increased expertise, quality assurance, scalability, and avoiding experimental bias. Outsourcing RNA extraction services can provide the best value for money to organizations in the biotech, pharmaceutical, or academic industry. To contact one of our experts about how outsourcing RNA extraction can level up your research, click here.