Support for single-use systems throughout the biopharmaceutical manufacturing process

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GENERAL: Your company maintains that the single-use assembly supply chain is the biggest bottleneck in biopharmaceutical manufacturing. Can you explain why this is the case and how you solve this bottleneck?

Wurm: As the need for single-use systems increased during the pandemic, shortages have intensified challenges for the biopharmaceutical supply chain. Speeding up lead times while maintaining product quality is crucial.

In keeping with the philosophy of single-use support – ‘it’s speed that counts’ – we have taken swift action to alleviate this industry-wide pain, that is, to provide sets of disposable collectors in the shortest possible time.

We have just launched our online configurator MyManifold to dramatically improve the ordering process for single-use sets. The combination of allowing customers to build / design their own assemblies and getting quotes for their custom manifolds on an online platform makes the buying process easier. But, most importantly, it speeds up the deadlines. From the quote to the secure receipt of your sterilized and customized single-use collection set, it takes eight weeks.

GENERAL: What specific applications in biopharmaceutical manufacturing does your company offer to its customers?

Wurm: Single Use Support is a provider of innovative solutions for all kinds of applications in biopharmaceutical manufacturing. Our focus is on providing platform systems and sterile consumables to protect, fill, freeze, cold chain, transport, thaw and drain valuable biopharmaceuticals. We have flexible, vendor-independent systems that allow users to fill not only any preferred single-use bag with liquid, but also any rigid container on the market. The fields of application range from the production of successful vaccines to mAbs, ADCs and cell and gene therapies.

Our goal is to solve manufacturing problems with new products and services so that biotechnology and biofabrication companies can focus only on research and development of their product.

GENERAL: What are the “gaps” that you focus on between downstream operations and filling and finishing operations that need to be filled, and what specific methods do you use to fill those gaps?

Wurm: Here is an example. You might think that the final liquid drug substance will be poured into vials in the same place. This is not the case. The shipment of drugs, ATMPs, CAR-T therapies or various fluids around the world is often unavoidable. Single Use Support’s BULK.STREAM® logistics process for liquids covers the four main areas of filling, freezing, thawing and shipping to ensure an efficient and safe process, ensuring optimum product quality.

GENERAL: Can you tell us about the portfolio of technologies you offer to cover all stages of the process 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 heavy-duty storage and shipping. The sophisticated material configuration forms the basis of the end-to-end process scaling from a few milliliters to hundreds of liters. The use of the RoSS shell facilitates the manufacturing
companies avoid product losses by leaking single-use bags to around 0%.

RoSS.FILL is a fully automated and flexible platform for the allocation and distribution of drug substances in single-use bags or bottles. The liquid path accommodates a single-use manifold with a multitude of sterile components.

RoSS.pFTU is our plate-based freezing and thawing platform to perform scalable, controlled and fully automated freezing processes. There are many other products that complement the processes for storing and shipping high quality substances. Single Use Support’s process solutions are supported by standards, eliminate material deficiencies and minimize human errors. Additionally, we offer a full range of services including Personal Platform System related services to minimize downtime. We also offer comprehensive consulting services to find optimal product integrations during complete processes instead of solutions for single steps.

GENERAL: Finally, how long have you been serving the biofabrication industry and where do your skills and expertise come from?

Wurm: Single Use Support has served the industry for over 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 all started with a vision in a garage and grew into a $ 150 million business. Over the past two years, the number of employees has grown from 15 to 140. The company’s goal is to simplify bioproduction for our customers and improve the quality of life for patients through new technologies that eliminate deficiencies in the transfer of pharmaceutical liquids.

Find out more: www.susupport.com


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