Single-use bioprocess container protected in a robust shipping and storage (RoSS) shell

The evolution of single-use technologies (SUTs) is among the most important developments during the past 20 years of biomanufacturing. Large stainless-steel containers have long been used for storage and cooling of drug substances. However, there has been a shift toward SUT, which has enhanced manufacturing agility and flexibility. Establishment of single-use systems also has built a solid foundation upon which to improve production of several types of biopharmaceuticals, including mRNA, allogeneic cell therapies, and viral-vectored gene therapies. Especially for emerging modalities, single-use equipment is a logical choice. Manufacturers need to fill, freeze, and ship such therapies quickly. SUTs enable multimodal production, enhance throughput, and expedite changeover procedures. Disposable bioprocess systems also help companies to work flexibly, breaking up conventional batch sizes.

Single Use Support stands for customer-focused solutions surrounding single-use systems. We seek to improve pharmaceutical fluid management and cold-chain logistics, with the goal of minimizing product loss. We provide end-to-end process solutions consisting of sterile consumables such as single-use bioprocess containers, related assemblies, and robust storage and shipping (RoSS) shells to protect bioprocess solutions. We also provide platforms for automated aseptic filling, controlled and scalable freezing, cold storage, shaking, and shipment of drug substances and products.

We believe that it is imperative to develop end-to-end systems that can be applied with all types of single-use bags or bottle containers. Adopting a vendor-agnostic approach to fluid management has helped us to succeed. Manufacturers have different process steps and different requirements for their operation in place. Therefore, room must be made for adaptation and flexibility — for different primary packagings, vendors, sizes, sample bags, and even mandatory tubings as long as two meters. There are countless possibilities.

Our RoSS robust secondary packaging solution is designed to accommodate different scenarios. In addition to its robust, protective properties, the RoSS shell provides a closed and tamper-evident environment that can be implemented regardless of what single-use system is inside it. We also understand the importance of providing fluid-management solutions for multiple batch sizes, from a few milliliters to several hundred liters, along with full services for engineering, qualification, and after-sales support.

Current SUT Needs and Goals
Modern medicines call for modern technologies. Fluid-management and cold-chain solutions for all biopharmaceuticals — be they allogeneic or autologous cell therapies, gene therapies, or novel types of vaccines, in clinical studies or in highly commercialized blockbuster production — are changing. Biomanufacturers are moving from conventional technologies toward modular and adaptable SUTs paired with automation. Automated systems enable standardization of process steps, increase reproducibility of experiments and processes, and reduce contamination risks associated with operator handling. Once drug-substance filling, freezing, and thawing procedures can be automated, controlled, and scaled, the Pharma 4.0 concept will be within reach. As an innovation-driven company, we seek to be at the forefront of the digital transformation of pharmaceutical processes.

RoSS.Fill automated filling system
for single-use bioprocess bags

Cold-chain solutions must become much faster and more cost effective to help achieve better outcomes for drug developers and patients. Our RoSS technology enhances protection of single-use bags and enables standardization of robust cold-chain logistics. The need to improve cold-chain logistics is urgent for time-sensitive therapeutics such as autologous and chimeric antigen receptor T (CAR-T) cell therapies. Improving cold-chain technologies also will foster traditional protein-based drugs in the long run. With controlled and scalable cryogenic solutions for pharmaceutical products, Single Use Support is addressing significant needs within the biopharmaceutical industry. In turn, cold-chain operations can move more quickly, become more cost effective, and ensure safe product handling. After all, our common goal is to prevent losses of single-use bags that contain valuable drug substances and products.

The COVID-19 pandemic has revealed vulnerabilities in the life-sciences supply chain. Biopharmaceutical companies depend on reliable supplies of SUTs and corresponding equipment. Current lead times for such materials can reach 12 months or longer. Meanwhile, more biomanufacturers are implementing SUTs than ever before. That trend, exacerbated by the COVID-19 pandemic, is leading to a general shortage of raw materials, especially plastics, so suppliers of SUTs have ramped up their production capacities to fulfill the increased demands of the market. But those companies depend on their own suppliers for raw materials, so the current supply-chain situation is tense. It will be critical to develop new strategies for production planning, not only for biomanufacturing companies, but also for suppliers — and their suppliers.

The Future of Biopharmaceutical Fluid Management and Cold-Chain Operations
The biopharmaceutical industry is showing greater receptivity to innovation than ever before. Drug developers now discuss their pain points and operational challenges, and they are willing to find new solutions. At Single Use Support, we believe that building trust between suppliers and biomanufacturers, along with a hands-on mentality, helps to devise innovative solutions. With the help of interactive industry–academia facilitators and through transparent discussions, obstacles can be converted into opportunities. We have learned that the industry is open to breaking new ground, and we at Single Use Support are committed to shaping the future together.

We now enter a new era of groundbreaking medicines, with regulatory approvals of mRNA-based vaccines, new CAR-T products, antibody–drug conjugates (ADCs), and other promising modalities. As a provider of process solutions, Single Use Support seeks to eradicate deficiencies in pharmaceutical liquid transfer, including operator errors, cross-contamination, uncontrolled freezing/thawing, shipping complications, and other problems that arise along a drug’s journey to patients.

A single-use bag filled with liters of a drug substance is highly valuable. Despite its criticality, its protection from breakages or leakages often is neglected. Uncontrolled freeze–thaw cycles risk compromising product quality through the effect of cryoconcentration. Unpredictable events during shipping can harm drug products, as well. With our end-to-end solutions, we aim to contribute to the improvement of the biopharmaceutical industry’s cold-chain logistics in the coming years. In turn, biotechnology companies can focus their efforts on improving human health and quality of life.

We plan to expand our product portfolio with innovative solutions that can be integrated into different processes. Moreover, we will continue to solve problems based on industry requests. Only customer-centered innovations can become truly disruptive. Custom solutions also could be translated into different applications or used across different manufacturing sites.

Single Use Support is well known for being a speedy, agile, and trustworthy partner that provides cutting-edge solutions at short lead times. We are proud to have already diminished the incidence of product loss for many customers globally. Hence, we are paving the way for SUT to develop further in the coming years. Fueled by the improved performance of SUTs protected by RoSS shells, we are committed to preventing future bottlenecks for single-use systems. Our slogan, “Pioneering Biopharma,” is manifested in our corporate DNA, and that sentiment will drive us to help advance the pharmaceutical industry.

Wolfgang Walcher is chief commercial officer at Single Use Support, Endach 36, 6330 Kufstein, Austria; 43-664-398-2769; https://www.susupport.com; [email protected].