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GEN: Your company maintains that the supply chain of single-use assemblies is the biggest bottleneck in biopharmaceutical manufacturing. Can you talk about why that is the case and how you address this bottleneck?
Wurm: As the need for single-use systems has increased during the pandemic, shortages have intensified biopharmaceutical supply chain challenges. It’s crucial to accelerate lead times while maintaining quality of the products.
In alignment with the Single Use Support philosophy—“it’s the speed that counts”—we took quick action to alleviate this industry-wide pain, i.e., to offer single-use manifold assemblies in the shortest time possible.
We have just launched our online configurator MyManifold to radically enhance the ordering process for single-use assemblies. The combination of allowing clients to build/design their own assemblies and obtain quotes for their custom manifolds on one online platform facilitates the purchasing process. But, most important, it accelerates lead times. From the quote to safe receipt of your sterilized and custom-made single-use manifold assembly it takes eight weeks.
GEN: Which specific applications in biopharmaceutical manufacturing does your company provide coverage for clients?
Wurm: Single Use Support is an innovative solution provider for all kinds of applications in biopharmaceutical manufacturing. Our focus area is providing platform systems and sterile consumables to protect, fill, freeze, cold chain store, transport, thaw, and drain valuable biopharmaceuticals. We have flexible and vendor-agnostic systems that allow users to fill not only any preferred single-use bag with liquid, but also any rigid container on the market. The areas of application range from blockbuster vaccine production to mAbs, ADCs, and cell and gene therapies.
Our goal is to solve problems in manufacturing through novel products and services so that biotechs and biomanufacturing companies can solely focus on the research and development of their product.
GEN: What are the “gaps” you focus on between downstream and fill and finish operations that need to be closed, and what specific methods do you use to close these gaps?
Wurm: Here’s one example. You might think that the final liquid drug substance will be filled into vials at the same location. This is not the case. Shipping drug substances, ATMPs, CAR-T therapies, or different liquids around the globe is often inevitable. Single Use Support’s BULK.STREAM® logistics process for liquids covers the four core areas of fill, freeze, thaw, and ship to secure an efficient and safe process, guaranteeing optimal product quality.
GEN: Can you talk about the portfolio of technologies you offer to cover all process steps as end-to-end solutions?
Wurm: It all started with the RoSS shell, which is a protective shell around any single-use bag available for robust storage and shipping. The sophisticated material setup forms the basis for the scalable end-to-end process from a few milliliters to hundreds of liters. Using the RoSS shell helps manufacturing
companies avoid product loss through single-use bag leakages toward 0%.
RoSS.FILL is a fully automated and flexible platform for the allocation and distribution of drug substance into single-use bags or bottles. The liquid path can accommodate a single-use manifold with a multitude of sterile components.
RoSS.pFTU is our plate-based freeze and thaw platform to perform scalable, controlled, and fully automated freezing processes. There are many more products that round off processes that enable storage and shipment of high-quality substances. Single Use Support’s process solutions build upon standards, eliminate material deficiencies, and minimize human errors. In addition, we offer a comprehensive range of services, including personal platform system-related services to minimize downtimes. We also offer full-process consulting services to find optimal product integrations during complete processes instead of solutions for only single steps.
GEN: Finally, how long have you been serving the biomanufacturing industry and from where did your skills and expertise originate?
Wurm: Single Use Support has been serving the industry for more than five years. Johannes Kirchmair and I, co-founders of the company, had already gained experience in the single-use industry before founding the company. It began with a vision in a garage and has grown to become a $150M company. Within the last two years, the number of employees has increased from 15 to 140. The company’s goal is to simplify biomanufacturing for our customers and improve the quality of life for patients with new technologies that eradicate deficiencies in pharmaceutical liquid transfer.
Learn more: www.susupport.com