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The evolution of single-use systems for the bioprocess industry and the emergence of unmet needs

lab worker

Single-use bioprocessing was born in the early 1990s with two main players: HyClone Laboratories and Stedim. HyClone, a supplier of serum and cell culture media, began to use “bio” bags for packaging sterile cell culture media. Stedim, on the other hand, was already a supplier of 2D EVA bags for the parenteral nutrition market since the late 1970s. Soon, customers of HyClone began asking them to supply not only the bags filled with media, but also empty sterile bags for use in their own processes. Stedim saw the opportunity to offer different versions of their existing products to the bioprocess industry, and in about 1998, the Flexboy® bag was born. The product name intended to introduce people to the “flexible carboy.”

Over the years, several notable players entered the market, each leaving their own mark. Most have since been acquired and/or renamed. HyClone, of course, was acquired by Thermo Fisher Scientific, with the cell culture media business sold to Cytiva as part of required divestment to allow Thermo Fisher Scientific to acquire Life Technologies’ media business. Stedim became part of Sartorius Stedim Biotech through a reverse merger in 2007. Wave Biotech US, the inventor of the single-use bioreactor, was acquired by what was then GE Life Sciences, now Cytiva and part of Danaher. Meanwhile, Switzerland-based Wave Biotech AG was acquired by Sartorius. TC Tech originally partnered with Sartorius, but was then acquired by Thermo Fisher Scientific, with the brand eventually being phased out. Xcellerex, a pioneer in suites of single-use bioprocess systems, was also acquired by GE Life Sciences. Millipore bought Newport Biosystems, Pall bought the life science business of ATMI, and so on and so on. While all this was happening, Advanced Scientifics Inc. (ASI) quietly built a significant business based on component and design flexibility and quick delivery times, and was eventually acquired by Thermo Fisher Scientific in 2015 for $300 million! Many companies have been established since and almost none have gone, except by acquisition.

Most of the companies discussed above entered the market with some degree of vertical integration. The companies offered products often based on specific capabilities and were nearly 100% custom, with customers coming to view the suppliers as outsource partners. As the customer base asked for more and more single-use solutions from these suppliers, these products often had no vertical technology integration remaining from the original products. The core capabilities of cleanroom assembly and sterilization management made the transition to supply these products an easy one.

Enter the “first-level integrator.” The early success of single-use systems (SUS) led the big players to occasionally be criticized as inflexible, slow to respond, and having inconsistent and sometimes long lead times. Meanwhile, regional tubing, pump and component distributors saw this as an opportunity. Customers asked if they could supply finished SUS, focusing on the “non-vertically integrated” assemblies. The success of ASI set the stage for these players to enter the market as integrators or outsource partners to design, build and sterilize custom SUS. Eventually, the major tubing suppliers entered the game, with their own vertically integrated tubing incorporated into finished SUS.

The bioprocess boom of 2020, which seems to be continuing unabated into 2021, has attracted even more players into this space, with more and more integrators entering the market.

But this market is not easy. End-users demand custom solutions with a quick turnaround. They may be in early-stage clinical production, where their demand is spotty, has a long lag phase or disappears altogether. The fast and flexible business model remains the key to early success for many, but the needs of these integrators are not well served by the existing sales channels for components for single-use bioprocessing. Most component OEMs only sell their own products, have high minimum order quantities and long lead times. Regional distributors often carry no inventory, have a limited product range and may be shifting away from component distribution to focus on becoming an integrator. The large catalog houses tend to have high prices, unpredictable inventory, gaps in their portfolio, and insufficient quality and regulatory infrastructure.

The misalignment of customer needs and sales channel support leads to difficulties for the integrators: their component warehouses are becoming larger than their cleanrooms, and they often have lots of inventory but not the right inventory. Their picking, kitting and warehousing activities have become overwhelming. They’ve become dependent on too many suppliers, with supplier lead times driving their production schedule, undermining the key value proposition for their customers and exposing an underlying supply risk.

This unmet need in the bioprocess space has led Qosina, a leading global supplier to the medical device industry for 40 years, to expand our portfolio to serve the needs of SUS integrators. The medical device and SUS industries are almost identical: high quality components, backed by regulatory support documentation.

bioprocess products

Qosina has worked with some of the best-known brands in the medical device industry. Our experience serving the needs of regulated customers positions us well to expand our products and services for the single-use bioprocess community. We have leveraged this experience and our extensive supply chain to provide a much-needed resource for bioprocess.

Qosina enables SUS integrators to focus on their core competencies to bring innovation, speed and agility to their customers without sacrificing assurance of quality supply. We do this by leveraging our strengths to deliver business continuity, consistent quality and change control to the supply of SUS components. We have curated a comprehensive portfolio of high-quality components meeting the technical and commercial needs of the single-use industry. We further support SUS integrators with kitting services, allowing them to outsource their warehousing and kitting activities. Technical, quality and regulatory documentation, which can be easily downloaded directly from our website, enables SUS integrators to support their customers at the highest level in the industry. Larger integrators can also benefit from outsourcing B and C supplier management, allowing them to focus their resources on their critical, strategic A suppliers.

Explore Qosina’s single-use bioprocess component selection at https://www.qosina.com/bioprocess.