Tue 26 Nov, 2019

How DKMS LIFE SCIENCE LAB is Supporting the Fight against Leukemia with New Processes and Automation DKMS LIFE SCIENCE LAB relies on a unique CMV analysis method and flexible automation solutions to match leukemia patients with the best possible stem cell donors.

Every 35 seconds great misfortune strikes, because every 35 seconds a patient is diagnosed as having leukemia. A long and difficult wait for a stem cell donor begins for those who are affected. Hundreds of thousands of patients are searching worldwide. The process of matching patients with donors is difficult. Simply having an identical blood type is not enough. Many other genetic parameters must match in order for a stem cell transplant to succeed.

Consequently, things are running at full steam in DKMS LIFE SCIENCE LAB in Dresden; thousands of samples of potential stem cell donors are analysed here every day. Highly-detailed donor profiles are generated from the data obtained from the laboratory analyses. The information is fed into the DKMS stem cell donor database; with over 9 million donor profiles, it is the largest global database of its kind. DKMS gGmbH brings donors and patients together all over the world. Thanks to the detailed profiles provided by the laboratory, the probability of successful stem cell transplantation  increases enormously. In addition to the 12 HLA profile characteristics (HLA – human leukocytes antigens), many other markers are being analysed. One of them is the CMV status (CMV – cytomegalovirus) of potential donors. Selecting a donor who has CMV status compatible with the patient reduces the risk of additional complications.

In order to automate a new, internationally unique CMV genotyping method, DKMS trusted in the expertise of Analytik Jena.

The task: CMV identification with high-throughput

CMV is a kind of herpes virus. Infection with the virus can be life-threatening to leukemia patients with a weakened immune system. Up to now, identification of the CMV status of potential stem cell donors was only possible based on blood samples. However, approximately 90 percent of the samples received by DKMS LIFE SCIENCE LAB are cheek swab samples, in the form of buccal swabs with saliva and cells of the oral mucosa. This was sufficient for identification of HLA markers and other genetic parameters, but not for the CMV status. This meant that, for the majority of potential donors, the CMV status could not be identified at the time of registration. In every case, the CMV status will be checked again immediately before a transplantation via antibody detection. If all information is already available while choosing a potential donor, the selection can be made much faster and more targeted. DKMS LIFE SCIENCE LAB has therefore developed a new method in order to begin the CMV analysis process at the time of registration. The identification of the CMV status determined from buccal swab samples sets new standards for CMV analysis.

Therefore, the number of CMV analyses rose immensely. Accordingly, the original laboratory facility had to be adapted to meet the new conditions. It was necessary to adapt the existing automation systems in order to scale up from the previous 15,000 samples per month to 100,000 per month and at the same time to ensure the highest-level quality of the analyses ‒ an enormous challenge.The automation of such a process is, of course, no easy task. Many factors need to be taken into account and many parameters have to be brought in line with each another. Boosting the sample throughput was imperative, however. Higher throughput, in this case, simply means saving more lives.

DKMS LIFE SCIENCE LAB worked with Analytik Jena to find a solution.

The solution: scalable laboratory automation with flexible systems

DKMS LIFE SCIENCE LAB redundantly plans the equipment for each process step in the analysis workflow redundantly and selects the optimum system for the respective purpose. This is important in order to ensure a smooth workflow and compensate for any potential malfunctions. The systems must also be flexible, i.e., they must be capable of being integrated into an existing systems environment and be easily operable and adjustable by the user. Not only is the performance capability and flexibility of the utilised equipment decisive for the laboratory, but the service delivery of a manufacturer also plays a key role in the decision-making process. A high-throughput system, such as that of DKMS LIFE SCIENCE LAB, must operate continuously. If there is a malfunction or even a failure, the registration process is delayed. In the worst case, this would mean that not all parameters of the potential donor that are relevant for the transplantation can be analysed. Quick response times from the manufacturer and solution-oriented service are therefore crucial to DKMS LIFE SCIENCE LAB. Analytik Jena was convincing in every way. The CMV status identification by DKMS LIFE SCIENCE LAB is based on a special ELISA assay. 6,000 samples should be processed by the automated system daily. Analytik Jena has developed a customised automation system in line with the laboratories’ requirements. The solution is an automated facility with systems from Analytik Jena, as well as other integrated third-party equipment. Its core component is the CyBio FeliX, a flexible, modular pipetting platform that was integrated in the CMV workflow in a 96-well version.

In addition to the performance and compatibility of the different systems, numerous ergonomic aspects were included in the design. After all, it is not just technical performance that demonstrates a workflow’s efficiency. The layout of the systems, easy access for users and service technicians to all components, meticulously devised provision of liquids, and easy usage of the hardware and software are essential for long-term, efficient operation. First of all, DKMS LIFE SCIENCE LAB and Analytik Jena’s Lab Automation Team worked closely together to simulate the workflow in order to identify possible bottlenecks. The facility was initially only planned to have one CyBio FeliX pipetting platform, but was subsequently expanded with a further CyBio FeliX. This way it was easily possible to meet the increased throughput requirements. After integration of the hardware, DKMS LIFE SCIENCE LAB and Analytik Jena optimised the workflow on the software side. DKMS LIFE SCIENCE LAB and the Analytik Jena software team reduced the cycle time of the CMV analysis significantly – from 15 minutes to just 8 minutes. The laboratory is now able to identify the CMV status of up to 6,000 samples per day.

In order to ensure attainment of the planned throughput of 1,000,000 samples per year, Analytik Jena set up a second facility after successful validation of the first one.

Your donation saves lives

Only one-third of all leukemia patients find a suitable donor within their families. The majority need a non-related donor. The broader and more diverse the assortment of samples, the more donors can be successfully matched. Register yourself as a stem cell donor and give others a second chance at life.



The facility in detail

Preparation of the analysis plates and sample transfer is done with two CyBio FeliX systems. Transport of the plate between the individual stations is handled by a SCARA robot from Precise Flex (Precise Flex 750). The addition of a dilution solution occurs in 88-channels in parallel with a selectively populated CyBio RoboTipTray. The transfer of samples is also done with a selectively populated CyBio RoboTipTray. After each transfer, the tips are automatically cleaned in a washing station. The control solutions are removed from a pre-filled half-deepwell plate. At the beginning of the process, it is possible to define the start columns in order reuse control plates which have already begun to be used. The washing and the dispensing of the plates takes place on two separate devices. This way the washer (Biotek ELX405 LSUVS) can already effectively wash in the 96-well format while, in parallel, one of the four reagents be added to the dispenser (Biotek MultiFlo MFXP). A CyBio QuadStack microplate storage unit with an integrated bar code labeler is in operation for the passing in and out of the plates. Thanks to the four bays of the CyBio QuadStack, it is possible to store non-processed and processed sample and ELISA plates at the same time. Incubation takes place in an incubator (Liconic STX44-ICBT) with a capacity of 44 micro plates. A random-access rack with 15 plate places can be used for the room-temperature incubations. A reader system (Biotek Synergy HTX) performs the photometric read-out of the plates. The facility is managed by the CyBio Scheduler software. It enables the ergonomic start, the status indicators, and the unattended running of the entire automation solution.

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