How single-use systems began

HyClone Laboratories and Stedim were the first to commercialize single use bioprocessing in the early 1990s. HyClone, a serum and cell culture media provider, started using "bio" bags for sterile cell culture media packaging. Since the late 1970s, Stedim has been a provider of 2D EVA bags for the parenteral nutrition industry. Customers started asking HyClone to supply empty sterile bags as well as media-filled bags for use in their own operations. The Flexboy® bag was born around 1998 when Stedim saw an opportunity to sell new variations of their existing products to the bioprocess industry. The name of the product was chosen to draw people to the concept of a "flexible carboy."

Later, several well-known players joined the industry, each leaving their imprint in terms of service and diverse product line. Many of those were subsequently purchased and/or renamed. Of course, Thermo Fisher Scientific bought HyClone, and the cell culture media division was bought by Cytiva as part of a mandatory divestiture to enable Thermo Fisher Scientific to buy Life Technologies' media division. In 2007, a reverse merger brought Stedim and Sartorius Stedim Biotech together. Wave Biotech US, the developer of the mono-use bioreactor, was purchased by GE Life Sciences, which is now Cytiva and a Danaher company. At the same time, Sartorius purchased Wave Biotech AG, a company based in Switzerland. After the acquisition by Thermo Fisher Scientific, TC Tech's partnership with Sartorius ended, and the brand was slowly phased out. GE Life Sciences also bought Xcellerex, a leader in single-use bioprocess systems. Millipore purchased Newport Biosystems, Pall purchased ATMI's life science division, a long history of buying and selling of the life sciences industries and change of hands. As all of this was going on, Advanced Scientifics Inc. (ASI) secretly established a substantial market focused on product and design versatility and fast turnaround times, ultimately being purchased by Thermo Fisher Scientific for $300 million in 2015!

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Single-use components have proven benefits and advantages for every type of bioprocess

Custom single-use solutions

The majority of the firms listed above were vertically integrated when they first entered the industry. Customers came to regard the vendors as outsource partners because the firms delivered goods based on their capabilities and were almost 100% customized. When the consumer base started demanding more and more single-use options from these vendors, there was no vertical technology convergence of the original manufacturing process. The transformation to supply these materials was made simple by the key skills of cleanroom assembly and sterilization management.

Then entered what is known as a "first-level integrator."  With the increasing popularity and success of single-use systems (SUS), the major players were accused of being rigid, sluggish to adapt, and having erratic and sometimes long lead times. At the same time, Regional manufacturers of tubing, pumps, and components, saw this as a unique chance to make advances. Customers asked if they could supply completed SUS, with an emphasis on "non-vertically integrated" assemblies. ASI's growth paved the way for these companies to join the industry as integrators or outsource partners for custom SUS design, construction, and sterilization. Through their own vertically integrated tubing inserted into finished SUS, the main tubing manufacturers eventually joined the game. 

The state of single-use systems in 2021

The bioprocess explosion of 2020, which seems to be going unabated into 2021, has drawn even more players to the industry, with more integrators joining the fray.

However, this is not a simple business. End-users need customized applications delivered quickly. They may well be in the initial stages of clinical development, with sporadic demand, a long waiting period, or little demand at all. For several, the swift and scalable market model remains the secret to early growth, but the current distribution platforms for single-use bioprocessing components do not meet the needs of these integrators. The majority of part OEMs only market their own goods, with large minimum order amounts and lengthy lead times. Regional distributors also lack inventory, have a small product range, and are increasingly focusing on being integrators rather than part distributors. Big catalogue houses have high premiums, unpredictably low inventory, portfolio shortages, and a lack of consistency and regulatory infrastructure.

Integrators face challenges due to a misalignment of consumer demands and distribution channel support: their product repositories are growing bigger than their cleanrooms, and they frequently have a stock but not the right inventory. They have become overwhelmed with the tasks like picking, kitting, and warehousing tasks. They have become overly reliant on so many vendors, with lead times shaping their manufacturing process, weakening their core business model for consumers, and highlighting an inherent supply vulnerability. 

How does Qosina tackle the single-use market?

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Pharsol offers a wide variety of single-use components, including custom assemblies, tailored to your specific bioprocess needs.

Qosina has partnered with some of the most well-known medical technology companies. Their experience of serving controlled consumers qualifies them to extend their goods and services to the single-use bioprocessing community. They have taken this knowledge and combined it with their vast supply chain to provide a much-needed platform for the bioprocess industry.

Qosina allows SUS integrators to concentrate on their core areas of expertise, allowing them to provide consumers with creativity, pace, and versatility without losing supply quality assurance. They have accomplished this by combining their experience to provide SUS product supply with market continuity, stable output, and change control. We have put together a diverse collection of high-quality components that satisfy the technological and industrial requirements of the single-use industry. We also provide kitting services to SUS integrators, enabling them to outsource their warehousing and kitting operations. SUS integrators will provide their clients with the best technical, quality, and regulatory assistance in the industry by downloading technical, quality, and regulatory documents directly from our website. Larger integrators will also benefit from outsourcing B and C supplier management, freeing up money to concentrate on their essential, strategic A suppliers.

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