May 26, 2020

Single-use technology hits the mainstream

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With changing requirements and the rise of new, more personalized treatments based on bioprocessed materials, biopharmaceutical manufacturers are progressively shifting from immobile stainless-steel tanks to more flexible and user-friendly single-use technology systems.

Single-use technologies have been the new standard for lab and clinical study purposes – where they were first being utilized due to their beneficial features regarding scalability and handling – for several years now. But they are now increasingly being adopted in the scope of commercial production too, where – quite opposed to the miniscule amounts necessary in the lab – several thousand liters per run are the norm.

While traditional stainless-steel systems are still the go-to solution for blockbuster production with all the requirements it entails, single-use platforms are becoming more and more viable for large-scale, not least because they can relatively easily be adapted to changing needs and requirements and because they offer the added bonus of optional compound and segregation attachments, all of them, of course, adhering to the demands that a sterile environment, respectively a sterile process entails.

RoSS.pFTU Large Scale

Single Use Technology – an unstoppable success story

The success of single-use technology systems is not least based on their disposable nature: Such platforms generally consist of several independent, pre-assembled parts made of plastic, which is much more flexible than stainless steel. As they are plug-and-play, they can be adapted to meet virtually any requirement, and in addition they also come sterilized, making tedious pre-manufacturing disinfection and cleaning processes a thing of the past.

Less floor space and a reduced need for infrastructure are just another two reasons why single-use technologies have hit the mainstream. And even with a constant need to repurchase certain parts such as disposable liquid pathways and other tubings, single use filtration areas or single use bags, the new technologies are still cheaper than traditional systems that are – to start with – costly to install, and that keep costs high, not least due to ongoing maintenance, cleaning and sterilization needs in addition to their inadaptability and inflexibility.

There are still hurdles in single use technology for the biopharma

While single use technologies still have their limitations, ongoing research and development are providing new and improved solutions at an accelerated rate. Until recently, single use bags were the main source of constraint, as they could only handle small to medium-sized volumes of highly valuable drug substance.

However, advances in bioprocessing technology, notably a steadily increasing upstream productivity, are consistently pushing the limits. Single use platforms can now accommodate up to 2,000 L; especially when having multiple systems running in parallel, they can compete with stainless steel vats and systems when it comes to producing enough to supply commercial markets.

So even though to date nearly all commercial manufacturing of biopharmaceuticals has involved the use of unwieldy stainless steel-based tanks and facilities, this is starting to change. And it is expected to transform the industry even more dramatically in the near future, with some new facilities implementing multiple 1,000 to 2,000 L bioreactor-based single use systems in parallel in order to manufacture volumes comparable to traditional stainless-steel production lines.

Another reason for increased adoption of single use can be found in the growing trend and need for personalized therapies such as CAR-T cell therapies and CGTs (short for Cell and Gene Therapies) that are based on the patient’s very own cells. The small amounts required for such treatments could never be processed in massive tanks and single-use platforms offer the perfect solution, both in terms of adaptability and scalability.

CAR-T cell therapy process Single Use Support

Potential bottlenecks and solutions for single-use technologies

In an annual survey of biopharmaceutical manufacturing professionals conducted by BioPlan Associates, the potential “breakage of bags and loss of production material” was still cited as a major disadvantage of single use systems by 46.2% of respondents.1

It remains one of the main weak points of single use but there is a solution:

The very nature of single use bags for biopharmaceutical purposes, which are generally made of a high-quality, yet thin and sensitive plastic membrane, makes them prone to breakage and ruptures caused by external stress and impact. This can lead to contamination and loss of highly valuable drug substance.

In order to eliminate this risk, Single Use Support has developed the so-called RoSS.shell that offers a protective sleeve for filled and frozen single use bags of any size. It is made up of a layer of soft 3D foam and a protective sleeve of robust and compact stainless steel to keep the content safe from external impact. It is just the last piece to make the entire puzzle called “single-use” complete. To find out more about the RoSS.shell and its compatibility with our single-use technology systems, click the button below.

Seed Train Intensification Process by Single Use Support

Do you know about our innovative seed train intensification process already? We developed a new process, called SEED.Stream – Check it out!

1 https://www.americanpharmaceuticalreview.com/Featured-Articles/354820-Biopharmaceutical-Manufacturing-is-Shifting-to-Single-Use-Systems-Are-the-Dinosaurs-the-Large-Stainless-Steel-Facilities-Becoming-Extinct/

the Bulkstream

Michael Eder

Business Development / Marketing Manager

Press

For any press related inquiries, please reach out to m.eder@susupport.com