Customer Story: DKMS LIFE SCIENCE LAB

How the DKMS LIFE SCIENCE LAB supports the fight against blood cancer with new methods and automationThe DKMS LIFE SCIENCE LAB relies on a unique CMV analysis method and flexible automation solutions to bring blood cancer patients together with the best possible stem cell donors.

In Germany, every 15 minutes, a patient suffers a stroke of fate – a diagnosis of blood cancer. For those affected, this marks the beginning of a long period of hope and anxiety. If the chemotherapy does not work or if there is a particularly high risk for the patient, the next step is to ask about a potential stem cell donor. Every year, the search for a donor is started for thousands of patients. Finding the right one is often not easy and depends on many factors. The determination of the blood type of donor and patient plays only a subordinate role here. Many, much more important, parameters must be determined and taken into account in a stem cell transplant in order for it to be successful.

In DKMS LIFE SCIENCE LAB Dresden is therefore very busy: thousands of samples from potential stem cell donors are processed here every day. From the analytical data obtained, the laboratory creates high-resolution donor profiles. The information flows into the DKMS stem cell donor database – one of the leading organizations of its kind with over 9 million registered donors worldwide. The DKMS brings donors and patients together all over the world. Thanks to the detailed profiles that the DKMS LIFE SCIENCE LAB creates, the probability that the stem cell transplant will succeed increases. In addition to the 12 HLA profile characteristics (HLA – human leukocyte antigens), the DKMS LIFE SCIENCE LAB analyzes many other markers, including the CMV status (CMV – cytomegalovirus) of potential donors. Selecting a donor who has CMV status that matches the patient reduces the risk of additional complications. For the automation of a new, globally unique CMV analysis method, DKMS relied on the Expertise of Analytik Jena.

The task – CMV determination in high throughput

CMV is one of the herpes viruses. Infections with the virus can be life-threatening in blood cancer patients with weakened immune systems. Until now, the CMV status of potential stem cell donors was only possible from blood samples. About 90 percent of the incoming samples in the DKMS LIFE SCIENCE LAB are cheek mucosa swabs that are taken from the oral mucosa with swabs called buccal swabs. From the DNA of the extracted oral mucosal cells, the HLA characteristics and other genetic parameters could be easily analyzed, but not the CMV status. This meant that for the majority of potential donors, CMV status could not be determined at the time of registration. In any case, the CMV status is checked again immediately before a stem cell donation via an antibody detection. However, if the information is already available during donor selection, the selection of a potential donor can be made faster and more targeted. The DKMS LIFE SCIENCE LAB has therefore developed a new method to carry out the CMV analysis process at the time of donor registration. The determination of CMV status from cheek swabs sets new standards for CMV analysis.

As a result, the number of CMV analyses shot up. The original laboratory setup therefore had to be adapted to the new conditions. Changes to the existing automation systems were necessary to scale from once 15,000 samples to 100,000 per month while ensuring the quality of analyses at the highest level - a major challenge. Of course, automating such a process is not an easy task. Many factors have to be taken into account and many parameters have to be reconciled. However, increasing sample throughput was essential. In this case, a high throughput ultimately means saving more lives.

The DKMS LIFE SCIENCE LAB found a solution together with Analytik Jena.

"High-quality products and excellent service make Analytik Jena an excellent partner for us"

Michael Brehm, Laboratory Technology and Automation DKMS LIFE SCIENCE LAB

The solution – scalable laboratory automation with flexible systems

The DKMS LIFE SCIENCE LAB maps each process step in the analysis workflow redundantly and selects the optimal system for the respective purpose. This is important in order to ensure a smooth workflow and to be able to compensate for any disruptions. In addition, the systems must be flexible, i.e. they must be integrated into an existing system landscape and can be easily operated and adapted by the user. But not only the performance and flexibility of the devices used is decisive for the DKMS LIFE SCIENCE LAB, the services of a manufacturer also play an essential role in the decision-making process. A high-throughput system in the DKMS LIFE SCIENCE LAB must work continuously. If there is a malfunction, or even a failure, the registration process is delayed. In the worst case, this means that not all transplant-relevant parameters can be identified for the potential donor. Fast response times of the manufacturer and a solution-oriented service are therefore very important to the DKMS LIFE SCIENCE LAB. Analytik Jena was convincing in all respects.

The CMV status determination of the DKMS LIFE Science Lab is based on a special ELISA assay. 6,000 samples per day were to be processed with the automated system. Analytik Jena developed a tailor-made automation solution in line with the requirements of the DKMS LIFE SCIENCE LAB. The key to success is an automation system with systems from Analytik Jena as well as some integrated third-party devices. The core component is the CyBio FeliX, a flexible, modular pipetting platform installed in the CMV workflow in a 96-well variant.

In addition to the performance and compatibility of the different systems, many ergonomic aspects were incorporated into the design. After all, an optimal workflow is not only characterized by technical performance. The layout of the systems, easy access for users and service technicians to all components, a well thought-out provision of fluids as well as the easy handling of the hardware and software are essential for long-term, efficient operation. In close cooperation between the DKMS LIFE SCIENCE LAB and Analytik Jenas Lab Automation Team, the workflow was first simulated in order to identify possible bottlenecks. The plant was initially equipped with only one CyBio FeliX pipetting platform, but was then expanded to include another CyBio FeliX expanded. In this way, the increased throughput requirements could be handled effortlessly. After the hardware integration, the DKMS LIFE SCIENCE LAB and Analytik Jena further optimized the workflow on the software side. The DKMS LIFE SCIENCE LAB and the software team from Analytik Jena significantly reduced the cycle time of the CMV analysis – from 15 to 8 minutes. The DKMS laboratory is now able to determine the CMV status of up to 6,000 samples per day.

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

Your donation saves lives

Only one third of blood cancer patients find a suitable donor within thefamily.The majority need an unrelated donor.The wider andmore diverse the selection,the moredonors can be successfully placed.Register as a stem cell donor and give others a chance at a second life.

BECOME A DONOR NOw

The plant in detail

The preparation of the analysis plates and the sample transfer are carried out with two CyBio FeliXSystems. A Scara robot from Precise (Precise Flex 750) transports the plates between the individual stations. The dilution solution is added 88-channel in parallel with a selectively equipped CyBio RoboTipTray. The sample transfer is also carried out with a selectively equipped 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 to reuse control plates that have already begun. The plates are washed and dispensed on two separate devices. Thus, on the washer (Biotek ELX405 LSUVS) can already be effectively washed in 96-well format and one of the four reagents can be added in parallel in the dispenser (Biotek MultiFlo MFXP). For the infeed and unloading of the plates, a CyBio QuadStack-Microplate warehouse with integrated Barcode Labeler in use. Thanks to the four bays of the CyBio QuadStack, it is possible to store non-processed and processed sample and ELISA plates simultaneously. The incubation takes place in an incubator (Liconic STX44-ICBT) with a capacity of 44 microdisks. A random access rack with 15 disk spaces is available for room temperature incubations. A reader system (Biotek Synergy HTX) handles the photometric read-out of the plates in the system. The system is controlled by the CyBio Scheduler software. It enables the ergonomic start, status indicators and unattended operation of the entire automation solution.

CMV Status

CMV stands for cytomegalovirus and belongs to the family of herpes viruses. Depending on the country, 30 to 90 percent of the population carry the virus. CMV infections in healthy people are harmless, but the virus can have life-threatening consequences in blood cancer patients with weakened immune systems.

Donors and patients should therefore have the same CMV status in order to prevent a possible outbreak of infection and to give patients the best possible chances for a successful stem cell transplant.

DKMS & DKMS LIFE SCIENCE LAB

The DKMS(formerly known as the German Bone Marrow Donor File) has set itself the goal of supporting the fight against blood cancer and giving as many patients as possible a second chance at life by arranging a stem cell donation. It is the world's leading stem cell donor database with over 9 million registered stem cell donors. Since the beginning of 1991, more than 81,000 stem cell donations have been arranged. The DMKS also conducts scientific research on blood cancer.

That DKMS LIFE SCIENCE LAB in Dresden, thousands of samples from potential stem cell donors are typed every day and create detailed profiles for the global donor registry. The laboratory has set new standards in high-throughput typing and also offers its experience to other organizations worldwide.