How Can You Let Your Diagnostic Target Analyte Shine?

The diagnostic industry is a crucial pillar of modern healthcare. It equips clinicians with vital tools and provides consumers with a range of at-home testing solutions. Recently, the sector has been transitioning from curative to preventive diagnosis, placing a greater emphasis on personalized offerings. But to meet aggressive milestones and stringent performance standards, there’s a need for continuous innovation and streamlined development and quality control workflows. Sartorius is a globally recognized supplier of the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. Sartorius understands the need for continuous innovation in the highly regulated and price-sensitive diagnostics market. In this Xtalks Spotlight feature, Xtalks spoke with two diagnostics experts from Sartorius: Wiktoria Banczyk, Strategy Analyst LPS, and Marvin (Ming) Xu, Manager of OEM DM Sales Asia. Banczyk and Xu shared insights into several challenges and solutions for the diagnostics industry. How Can You Let Your Diagnostic Target Analyte Shine? July 24, 2023 | Xtalks Editorial Article by Vera Kovacevic, PhD2 “In my opinion, one of the key challenges for the diagnostics industry will be keeping up with the technological advancements. As new technologies emerge, the industry must continually innovate and integrate these advancements into diagnostic practices,” Banczyk says. Banczyk has expertise in medical and IVD filtration devices. She has been involved in various medical and IVD product developments, and registrations, both internally and externally. Xu joined Sartorius in 2002. Over the past 14 years, he has focused on supporting IVD customers in Asia. His expertise in nitrocellulose membranes, especially in lateral flow tests, is unquestionably recognized. “By working with customers from the initial research stage through to the development stage and finally the production stage, Sartorius can address and remove any issues. This helps customers achieve high-quality test results,” says Xu, emphasizing the importance of collaboration between Sartorius and its customers. Sartorius’ Role in the Diagnostic Industry When asked about how Sartorius contributes to the diagnostic industry, Banczyk affirmed the company’s commitment to addressing the specific needs of their customers. Banczyk emphasized the critical role of reliability and consistency in diagnostic sample preparation. To this end, Sartorius meticulously designs its consumables to support the strict requirements of diagnostic testing. The company’s range of consumables includes filter papers, membranes, pipette tips, concentration or filtration devices and more, all manufactured to the highest standards in an ISO 9001-certified environment. These measures ensure batch-to-batch consistency and complete lot traceability, leading to accurate and reproducible sample processing before diagnoses. Banczyk goes on to explain that, beyond the quality of their consumables, the scalability and availability of their product range are also of paramount importance to Sartorius. They provide a comprehensive range of options to meet their customers’ diagnostic workflows effectively. For more unique needs, Sartorius offers a wide range of original equipment manufacturer (OEM) or private label products tailored to customers’ requirements. Wiktoria Banczyk Strategy Analyst LPS, Sartorius Marvin (Ming) Xu Manager of OEM DM Sales Asia Sartorius “We understand that diagnostic manufacturers often have diverse needs. We strive to offer a wide range of lab consumables to meet their needs.” Wiktoria Banczyk Strategy Analyst LPS, SartoriusKey Steps in Diagnostics Applications “The core expertise of a diagnostic manufacturer lies in the sensitive and specific detection of biomarkers. This is strongly influenced by the sample preparation steps performed in a diagnostic laboratory,” notes Banczyk. Sample preparation contributes to the overall success of diagnostic testing by removing interfering substances such as cell debris, proteins, lipids or inhibitors. In addition, techniques such as ultrafiltration can concentrate and enrich the target analyte, making it easier to detect. Notably, Banczyk highlights how proper sample preparation supports the preservation of the patient sample and the target analyte during storage and transportation, preventing degradation or loss of the analyte. Sartorius has developed application-specific instruments and consumables to ensure accurate and reproducible preparation of patient samples, as components of the overall validated diagnostic kit. Banczyk pointed to offerings such as liquid handling instruments with embedded workflows for strictly defined protocols, highpurity Safetyspace® pipette tips and Vivaspin® ultrafiltration devices. A Deep Dive into Diagnostic Solutions Xu describes Sartorius’ customers as mainly producing rapid tests with the lateral flow method, which is particularly suited for in-home tests. These tests range from pregnancy and fertility to infectious diseases, drugs of abuse and tumor and cardiac markers. “The manufacturers of these tests are mainly concentrated in East Asia and North America, with more than 50 percent of the manufacturers located in China,” says Xu. Xu highlights that Sartorius, as a well-established membrane manufacturer, has a rich history and expertise in producing nitrocellulose membranes, which are a key component in lateral flow tests. For example, Sartorius’ UniSart® nitrocellulose membrane is designed to bind proteins on both the test and control lines and to transport the sample-conjugate complex. The result is an easily visible test line and control line, which is crucial for diagnostics like the COVID-19 antigen test. Xu, with over 20 years of experience at Sartorius, shares how the company helps customers to choose the most suitable membrane for their application. “We are a small but efficient, dedicated global team. This makes us flexible to give fast feedback to meet customer requests,” explains Xu. “This dedication has resulted in solutions that not only increase test sensitivity but also help speed up time-to-market while reducing production scrap rates.” Xu mentions an instance where they developed a new membrane, CN 180 Dx. During the pandemic, this new Unisart® membrame with a significantly higher sensitivity was launched after a reduced development time and expedited product market entry. This shows Sartorius’s commitment to fulfill the needs of the market even in challenging times. And according to Xu, Sartorius isn’t just about membranes. They provide a wide range of solutions for the IVD and diagnostic market, including bioreactors, cartridges, cassettes, lab balances, papers and more. “Over the last three to four years, Sartorius’ UniSart membrane has been used to produce more than 16 billion COVID-19 antigen tests. We were proud of helping customers to fight against the pandemic globally, and in an extremely short supply time.” Marvin (Ming) Xu Manager of OEM DM Sales Asia SartoriusFurther Solutions for Lateral Flow Manufacturers The importance of lateral flow assays in the realm of in vitro diagnostics cannot be overstated. These assays have become an integral part of many diagnostic procedures due to their speed, simplicity and cost-effectiveness. However, the effectiveness of lateral flow assays is heavily reliant on the quality of the antibodies used in the immunoreactions and their interactions with the antigens. This is where Sartorius’ specific solutions, the Octet® systems, become crucial for manufacturers of lateral flow assays. “Octet® systems enable quality control of antibodies to ensure high purity and stability. Moreover, they provide association and dissociation rates of the antibody-antigen interaction, which supports the design and optimization of lateral flow assays,” explains Xu. The Octet® systems also offer a unique feature known as a binning assay. This feature allows manufacturers to distinguish between antibodies that bind to the same antigen but not the same epitope (the part of an antigen that the host’s immune system recognizes). This level of precision is invaluable in the optimization of lateral flow assays, as it can help streamline the process, saving time and costs for manufacturers. Importantly, the Octet systems are 21 CFR Part 11-compliant. This compliance means that the data generated by the systems can be used for Post Market Surveillance and can be made available in case of audits. Successful Collaboration and Business Case Banczyk shared an example of a successful collaboration with a global molecular diagnostic system manufacturer. The client needed a reliable centrifugal concentration solution for processing patient samples. They had specific criteria, including fast results, a low error rate, the lowest possible dead volume and very high sample recovery. “Our collaboration involved many departments such as Legal, Product Development, Product Management, Regulatory Affairs and Procurement,” says Banczyk. Sartorius’ Vivaspin® GLU devices with a polyethersulfone (PES) membrane met the client’s requirements, leading to a fruitful partnership and contributing to the successful launch of a first-to-market, sensitive and specific point-ofcare detection kit. This kit allowed clinicians and caregivers to make an immediate diagnostic decision. Sartorius’ Response to Industry Challenges According to Banczyk, one of the key challenges the diagnostics industry will face in the coming years is ensuring that new technologies are effectively used in a proper regulatory setting. Moreover, diagnostics must remain affordable and accessible, making the task even more challenging. In addition, Banczyk emphasizes the importance of standardization and quality assurance in the diagnostic industry.“Harmonizing test methodologies and protocols across all laboratories, establishing stringent quality control measures, and in the end, adhering to the regulatory guidelines will be essential steps in the next few years,” says Banczyk. To address these challenges, Sartorius has implemented various strategies. Banczyk explains that the company understands the importance of affordability and accessibility for the diagnostic testing industry. To this end, they have increased production capacities for many of their production lines, allowing them to scale up production effectively and reduce costs, ensuring a steady supply of their products. Secondly, Banczyk emphasizes the criticality of maintaining a continuous dialogue between their product development and regulatory affairs teams. “By working closely with regulatory bodies and staying up to date with the evolving landscape, we can streamline our