Successful biopharmaceutical manufacturing relies heavily on efficiency, safety, and adaptability. With these attributes Single Use Support, a process solution provider based in Austria, tackles one of the industry's biggest challenges: bridging the gaps in bioprocessing with end-to-end solutions in fluid and cold chain management. By focusing on single-use technologies and systems, the company has redefined how sensitive drug substances and advanced therapies are handled, stored, and transported across various stages of production.
Bioprocessing technology gaps everywhere
Biopharmaceutical manufacturing involves complex workflows that span from upstream processes (e.g., cell cultivation) to downstream steps (e.g., purification and fill-finish). Historically, inefficiencies in fluid and cold chain management have posed significant risks, including product loss, contamination, and delays. These issues often stem from inadequate packaging, manual handling mistakes, or a lack of scalable solutions for freezing and transporting delicate biologics.
Single Use Support started its journey by focusing on the transport of produced drug substances to be dispensed into vials, which are then sent to healthcare providers around the world. However, the company soon realized that its solutions cater to the unique needs of many biopharma manufacturers at every stage – from upstream fermentation to downstream processing and beyond.
- Upstream Processing: Intermediate working cell banking and fluid transfer to single-use bioreactors and bags simplify and shorten cell culture processes. Mircobial fermentation may require fluid and cold chain management solution for very large volume.
- Downstream Processing: Automated fluid management systems ensure precise filtration and aliquotation of drug substances within downstream, but also for cold chain shipment to fill-finish sites.
- Cold Chain Logistics: Integrated cryopreservation solutions ensure the safe freezing, storage, transport and thawing of sensitive materials.
- Fill-Finish Operations: Aseptic filling systems enable safe and precise transfer of drug substances into single-use bags or medical devices under sterile conditions.
The aim is to bridge the many gaps with innovative systems that enhance efficiency while maintaining product integrity across various product lifecycles, volumes, and bioprocessing applications.
Single-use technology as a game-changer
Single-use technology has emerged as a transformative force in biomanufacturing, particularly over the past ten years. Unlike traditional stainless-steel systems that require thorough cleaning regularly, including excessive use of energy, chemicals and water, single-use systems utilize disposable components like bioreactors, bags, and tubing. These components come pre-sterilized and ready for immediate use, which significantly reduces contamination risks and minimizes downtime between production runs. Moreover, the use of stainless steel does not provide manufacturers with the process flexibility needed in this ever-changing industry.
Single Use Support has advanced this idea by incorporating single-use technologies into comprehensive solutions for fluid management and cold chain logistics. The company’s platforms and consumables work hand in hand to automate essential processes such as filling, freezing, thawing, and shipping, ensuring that sensitive drug substances remain safe and effective throughout their entire journey.
Cold chain management to ensure product integrity and quality
A key strength of Single Use Support is its proficiency in cold chain management. Many biopharmaceutical products, including vaccines, monoclonal antibodies, and cell therapies, need to be kept at ultra-low temperatures to preserve their stability or viability. However, traditional freezing and transportation methods often lead to inconsistent temperature distribution or damage to packaging.
To address these challenges, Single Use Support developed advanced freezing technologies around the RoSS® shell. The secondary packaging for single-use bags allows for controlled-rate freezing and thawing, which ensures even ice formation throughout the bag and preserves high product quality – especially cell viability when freezing mammalian cells used in the production of monoclonal antibodies and other vaccines. The frozen materials are safeguarded in shells during storage or transport at temperatures as low as -80°C and even -170°C for gene therapies, minimizing product loss from bag breakages. These innovations not only protect product quality but also facilitate scalability for large-volume production.
The importance of advancements
As the demand for advanced therapies like vectors for drug delivery, nucleic acids and monoclonal antibodies continues to rise, so does the necessity for dependable manufacturing processes that reduce risks and enhance output. By addressing significant gaps in bioprocessing, Single Use Support helps pharmaceutical companies expedite the market introduction of life-saving treatments while also lowering costs.
Additionally, their emphasis on automation and scalability is in line with the industry's broader shift towards compliant and efficient manufacturing facilities. Automated systems not only cut down on labor expenses but also enhance reproducibility, which is crucial for maintaining consistent product quality across different batches.
What the future may bring
The biopharmaceutical industry is changing quickly, largely due to new therapies like personalized medicine that require even more flexible manufacturing processes. This change calls for systems that can efficiently manage small-scale production while ensuring the quality of the products. At the same time, there is a growing emphasis on sustainability, with initiatives aimed at reducing the environmental impact of single-use systems. Efforts to recycle disposable components without affecting their sterility or performance are essential for cutting down on waste. To tackle these challenges, innovation and teamwork will be necessary to find a balance between technological progress, environmental responsibility, and regulatory requirements.
Single Use Support helps manufacturers address all types of fluid and cold chain management inefficiencies and overcome significant bioprocessing barriers to ensure that life-saving treatments are safely and effectively delivered to patients. For more details check out Single Use Support to learn how to shape the future of biomanufacturing by closing gaps with precision-engineered technologies tailored to your workflow.