Brooks Cryopod™ Carrier and Automatic LN2 Filling Station
Launched in 2015, the CryoPod™ Carrier – an innovative, portable LN2 sample transport device – and the accompanying benchtop compatible Automatic LN2 Filling Station, won two product innovation awards for the year (ISBER & ESBB). As a handy portable device, it extends the cryogenic cold chain (-150°C temp) by over 4hrs and was recognized as a safe and effective way to transport cryogenic samples between labs within a building, or across the campus.
Digging deeper, further benefits were identified with the use of a CryoPod carrier within a biobank at a major biopharmaceutical company. The Director of the Biobank pointed out the improved user safety with a CryoPod vs. other homemade or improvised LN2 carriers as a primary benefit. Secondly, the fact that the CryoPod allows researchers to focus on science, and not worry about risks to sample integrity due to inadvertent temperature variances. In most major pharmaceutical companies the biobank is consolidated into a single area or building. This leads to space and cost efficiency for individual labs, and improves the quality and consistency of lab procedures handling. A perceived downside may be that the researcher now has to go to the Biobank to retrieve their samples. Pre-planning however, should be able to resolve this issue. A problem presented with consolidated storage was how a researcher gets their samples back to their lab and more importantly, what happens if they are not ready to thaw the samples immediately. The CryoPod makes it safe and easy to get samples from the biobank to the lab and it also gives the user time-safety by keeping the samples below -150°C for over 4 hours. The CryoPod carrier affords them the time they need while keeping their samples safely cryogenically frozen.
Now available to customers, the Automatic Filling Station is the perfect complement for the CryoPod carrier. For the Biobank Director, the top three benefits were safety, safety and safety. All LN2 handling in a lab involves exposure to LN2, dangerously cold surfaces and PPE restrictions. The Cryopod LN2 Automatic Filling Station can eliminate these risks. The user has to simply place the CryoPod inside the Filling Station, close the door, and press Start. In approximately 5 minutes the CryoPod is fully charged. Most Biobanks will likely choose to place the Filling Station at the central repository so researchers can fill their CryoPod, then retrieve samples and carry them back to their lab. But in very large campuses additional sample safety can be ensured with Automatic Filling Stations located in other buildings as well throughout the campus. Then if a CryoPod with samples in it is starting to warm to -150°C after 4 hours, the user can simply recharge the CryoPod within minutes to continue maintaining the required temperature.
User safety and sample integrity with convenience all wrapped up into the unique portable CryoPod carrier and the Automatic LN2 Filling Station. Learn more on the cryogenic solutions tab on www.brooks.com/lifescience.
CryoPod™ is a trademark owned by Brooks Life Science Systems, a division of Brooks Automation.
LGC – IntelliQube
LGC is a global leader in genomics technologies and services, responding to the needs of the biobanking community through discovery and leveraging genomic data for the benefits of patients. We deliver high-quality genomic solutions that enable breakthrough cost savings and also fully support both quantitative and end-point PCR applications from probe chemistries and MasterMix reagents, to instruments and NGS services. We have a complete suite of BHQ® probes, Array Tape®, and the IntelliQube® that offers an automated and fully integrated medium to high-throughput qPCR system.
Reducing human error while providing walk-away time
The IntelliQube* automates liquid handling, thermal cycling, detection and data analysis for both PCR and qPCR applications into a single, user-friendly instrument. It automates reaction setup and eliminates nearly all of the manual pipetting steps involved in PCR. Automatic sample and barcode reduces the opportunity for plate mix-ups or other human errors in the lab.
Exceptional sensitivity and qPCR performance
The IntelliQube cost-effectively produces accurate and reproducible data:
- Sensitivity: 1 to 2 Copies
- Dynamic Range: 6 Log
- Resolution: 1.2 Fold
- Cq Uniformity: SD < 0.2
- Estimated 8 Hour Throughput: Six 768-well Arrays or 4,600 data points
- For Research Use Only (RUO). Not for use in diagnostic procedures
QIAGEN – PAXgene Blood
QIAGEN launches novel integrated system for collection, stabilization, transport, storage and isolation of circulating cell-free DNA
Together with the QIAamp Circulating Nucleic Acid Kit – the gold standard in manual extraction of circulating cell-free DNA – and upcoming new automated ccfDNA isolation on the QIAsymphony, PAXgene Blood ccfDNA builds a fully integrated and complete standardized system covering all pre-analytical workflow steps from blood collection, stabilization, transport, storage and isolation of high quality ccfDNA.
The new system contains a unique non-crosslinking reagent in the collection tube that ensures DNA remains unmodified. It prevents post-collection release of genomic DNA from white blood cells – resulting in improved ccfDNA yield recovery with less background DNA. A minimized release of contents of ruptured red blood cells into blood plasma (hemolysis) enables a maximized plasma recovery, particularly critical in cancer research. Combined with the proven plastic BD Vacutainer® Tube technology, customers will benefit from consistent blood draws and no more glass tube breakage during the workflow.
The new preanalytical system significantly expands the range of liquid biopsy applications: While most other ccfDNA stabilization approaches contain potential formaldehyde releasing compounds – which make them unsuitable for many applications – the new PAXgene tube with its novel reagents is compatible with a wide array of downstream applications such as non-invasive prenatal testing (NIPT) or methylation-based assays in cancer research.
“Researchers performing ccfDNA analysis today are facing a number of severe pre-analytical workflow challenges: They need to prevent fast post-collection changes of ccfDNA profiles which can lead to unreliable analytical results. They need blood collection tubes with stabilization if they can’t separate blood from plasma in time. They need stabilization reagents not limiting their analytical downstream performance due to cross-linking, they need safe tube handling and high-quality isolation of complete ccfDNA profiles. But above all, they want a complete and fully integrated solution for all these steps”, said Brad Crutchfield, Senior Vice President and head of QIAGEN’s Life Sciences Business Area. “Our novel, completely integrated preanalytical system provides them with unseen application opportunities, safety levels, and workflow convenience – an important solution to further drive ccfDNA analysis in prenatal testing, cancer and many other clinical research areas. QIAGEN is leading the way in providing liquid biopsy solutions to take labs from Sample to Insight.”
“Securing high quality samples with preserved analyte profiles through integrated pre-analytical systems covering all workflow steps is a key prerequisite for reliable and valid analytical testing results” said Frank Augello, General Manager of PreAnalytiX GmbH (A QIAGEN / BD joint venture company) which developed the new system. “The PAXgene Blood ccfDNA System adds to the proven track record of pre-analytical systems powered by PreAnalytiX, which also includes solutions for various sample types and analytes, such as the gold standard PAXgene Blood RNA System for intracellular RNA analysis from whole blood”.
The new preanalytical system also complements a broad number of new liquid biopsy solutions QIAGEN is launching across the Sample to Insight value chain, including new QIAseq targeted panels using proprietary and innovative digital NGS technology.
QIAGEN is the only company providing Sample to Insight solutions in all three emerging approaches to liquid biopsies: circulating cell free nucleic acids, circulating tumor cells (CTCs) and exosomes. Its portfolio of liquid biopsy solutions continues to grow rapidly. In June, QIAGEN introduced its liquid biopsy workflow for the QIAact Actionable Insights Tumor Panel, tracking a broad range of biomarkers in clinical research to add valuable insights on the progression of the most common cancers. * PAXgene Blood ccfDNA Tube is for Research Use Only (RUO).
For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit handbook or user manual. QIAGEN kit handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services or your local distributor.
PERKINELMER – chemagicTM 360 Nucleic Acid Extractor
Biobanking applications, biospecimen repositories and Mircrobiome research projects are facing demanding and diverse sample materials like whole blood, FFPE-tissue to feces-material in all kind of sample volumes and conditions. To fulfill the needs of sensitive genetic research applications such as whole genome sequencing, real time/digital PCR, and methylation analysis etc., the extraction of high quality and high yield nucleic acids is an essential initial step, especially when it comes to long-term storage of the extracted DNA/RNA samples as required in Biobanking. PerkinElmer offers the perfect solutions for this challenge by providing
- Automated Nucleic Acid Isolation, highly flexible in sample volume (10 μl – 10 ml), sample material and throughput
- Huge variety of processable sample materials (blood, buffy coat, saliva, tissue, feces, etc.)
- Maximum yields and best purities (up to 50 μg DNA/ml blood; OD260/280 1.9; OD260/230 >2.0)
- Long term stable nucleic acids
Your Tool for DNA/RNA Isolation Workflows in Biobanking Based on your automation needs PerkinElmer offers full workflow solutions covering high throughput DNA/RNA isolation, liquid handling robotics, Nucleic Acid quality control and analysis, optimized for Biobanking and Biorepository demands.
- Sample volumes from 10 μl – 10 ml
- High throughput
- LIMS compatible log files, barcode reading Benefits
- Ready to use DNA/RNA – up to 50 μg DNA/ml blood
- Compact benchtop design
- Integrates with Liquid Handling Systems Automation solutions
- High throughput primary sample transfer and DNA/RNA Isolation
- Optional: normalization, PCR setup applications, eluate transfer into storage formats
- Numerous sample tube and plate formats for primary sample input and eluate output
- Barcode sample and eluate tracking for seamless integration to LIMS systems, sample security and storage solutions
Fisher Bioservice illustration
Biobanking for Biologics and Cell Therapies: All Biobanks Are Not the Same By Bruce C. Simpson, Director, Commercial Operations, Fisher BioServices
Until recently, most biorepositories were primarily used for archival sample storage. Researchers would generate large sample collections for research with a broad idea of how they would or could be used. Although this required expert temperature monitoring while in storage at biorepositories, it did not demand a lot of transactional activity, debits and credits from the inventory, as there was no defined use for the sample.
However, in the last ten years the industry landscape has evolved. With the introduction of advanced biotherapeutics and personalized medicine, biorepositories have transformed from archival storage facilities into true biobanks where the overall workflow now includes numerous complex transactions. Many of these transactions are associated with adding value through an integrated workflow that seamlessly connects the sponsor, bio-manufacturer, clinical center, and patient into a tandem, well-coordinated process chain. Additionally, in some instances sample collections are developed with a more targeted end-use in mind, resulting in smaller inventories.
Let’s explore the expanded focus across our industry from biorepositories for traditional research (biospecimens) to biobanking for therapeutic components (biologics and cell therapies).
Shift in Research Focus
For traditional research biorepositories, the business model was crafted to accommodate broad spectrum studies. Researchers gathered large biospecimen collections and this high quantity allowed them the flexibility of utilizing their sample collection for a variety of research.
Researchers now weigh their options differently than in the past; do they want to allocate funding to the storage of massive legacy collections? Or do they want to focus on smaller, more targeted collections that correlate to therapeutics? While many legacy collections still exist in biobanks today, research also now focuses on more targeted collections.
Biobanking for Biologics and Cell Therapies
The development, administration, and storage of a cellular therapy or biologic involves many moving parts. This is not due to regulatory demands being intensified, but rather as we have gained more experience, we have discovered additional challenges that must be overcome to ensure success. Autologous cell-based therapies use a patient’s own cells for the manufacture of a treatment that is then administered only to that patient. While the sample size for this process is very small (only one patient) the process is very complex. Allogeneic cell-based therapies are derived from an unrelated donor or donors and administered to the relevant population of patients. Allogeneic cell-based therapies are similar to biologics in the sense that if they are commercialized they can be manufactured on a large scale and administered to a larger sample size. Since these are biologically derived substances that are administered to the patient from an external environment there are many variables that can impact the safety and integrity of the biologics. Therefore, they require greater care in the custody of a biobank.
Due to the complexity associated with the administration of biologics and cell therapies to the patient, they experience many transactions in the chain of custody. This high volume of transactions increases the need for standardized processes to ensure the therapy remains efficacious. Based on the number of steps in the supply chain, it’s increasingly important to have safeguards in place that minimize risk and ensure the material is at the correct temperature and hasn’t experienced any excursions.
While temperature maintenance remains a critical aspect of sample integrity, researchers are now looking beyond temperature and focusing on the impact of long-term storage on sample integrity. In addition, there is increased attention to the data associated with the sample’s molecular viability, well beyond just the temperature data. These include freeze-thaw cycles, time out of temperature, sample handling and manipulation, and time in transit—all have become integral data points associated with measuring sample integrity.
One way to minimize risk is to proactively improve operations through internal process improvement initiatives. It’s also important to involve resources such as quality assurance, process managers, software compliance, and validations. Improvements in process and increased transparency among key organizational roles will enable a smooth transition throughout the chain of custody.
The evolution of biorepositories to biobanks has helped identify some of the necessary data points that should be analyzed when measuring sample integrity. By adhering to SOPs for biologics and cell therapies, you not only put in place procedures that ensure excellent management of biological material, but these SOPs trickle down and apply to biospecimen management as well. Whether managing high value material or a high volume of biospecimens, sample integrity is at the core of our industry. However, it is the valuable partnerships and proprietary biobanking processes, workflow, and risk mitigation tactics that truly set some biobanks’ expertise above the rest.
The costly nature of irreplaceable samples/cell lines and high value products such as cell-based drugs, and biological active pharmaceutical ingredient (Bio-API) dictates planning for the full continuum of risk. Download your free eBook Defense in Depth: Off-Site Storage for Biological Specimens and Biopharmaceuticals for Risk Mitigation and learn the right questions to ask when choosing an offsite storage facility.
Chart Biomedical – Vario tank
The MVE Variō Series is the innovative and energy-efficient alternative for ultra low temperature to cryogenic storage. The completely dry sample storage area will maintain a user-defined temperature anywhere between -20°C and -150°C. As a convertible asset, the MVE Variō Series can be converted to a high efficiency liquid nitrogen freezer that will enable dry sample storage to -190°C. The MVE Variō Series significantly reduces the possibility of sample contamination via contact with LN2 while providing the safety margin and consistent temperature profile, even with the lid open, that is associated with LN2-based cryogenic storage. The MVE Variō Series is able to provide all of this with less than 1% of the power consumption and approximately 70% overall operating cost savings when compared to the leading mechanical freezers.