Single-use technology has been touted as the latest and most promising development in bioprocessing technology, fast replacing stainless steel as the material of choice for many bioprocessing engineers. But how true is this? Could we be losing out by shifting away from stainless steel?

In the late 1990s, single-use technology began to emerge as a viable alternative to stainless steel in bioprocessing. For many, it has been viewed as the holy grail of manufacturing, promising fast process set-up, low upfront capital investment, reduced maintenance costs, more flexible manufacturing layouts and a reduction in validation times. For contract manufacturing organisations (CMOs), single-use systems are particularly appealing as clients often demand fast set up and an even faster production rate.

PLASTIC FANTASTIC

A recent BioPlan Associates report on biopharmaceutical manufacturing discovered the most critical reasons for using single-use technology: to eliminate cleaning requirements, reduce capital investment in facility and equipment, avoid costs associated with system redesign and modifications and decrease the risk of product cross‑contamination.

Clearly, single-use technology is the ideal choice for particular applications, some of which are setting the theme for the future of biopharmaceutical production. In recent years, we have seen a huge growth in small-scale manufacturing processes, such as advanced therapy medicinal products (ATMP). The success of therapies such as CAR-T will surely attract greater attention and investment in these types of manufacturing processes, and where manufacturers are designing systems to be taken out in the field, in war zones or in disaster areas, a closed, wholly disposable system is essential.

But we are at risk of assuming that single-use is the technology for everything, that it is the panacea for all procedures and situations. We can be at risk of throwing out state-of-the-art stainless steel systems that have evolved over decades for the latest new thing, only to find that it doesn’t quite deliver what we need.

The emergnce of new technolgy is shaking up the stainless steel industry

TRUSTing STAINLESS STEEL

Single-use technologies have their advantages, especially when it comes to avoiding contamination, as they eliminate the need for cleaning. This is important when it comes to satisfying regulatory requirements, an essential consideration for biopharmaceutical processing engineers. Up-front costs are also significantly lower than stainless steel components, leading to lower process redesign costs.

The single-use bioprocessing market in the Asia-Pacific region is predicted to be worth $1.4 billion by 2024. China currently leads innovation in this area with 33 per cent of new product launches in single-use technology in 2015, but Japan is fast following, showing exponential growth in the single-use sector.

Single-use does not come without its own challenges, however. Whilst upfront costs are lower, ongoing supply of components can generate significant expenses. Scalability is also an issue, with stainless steel still offering the best option for larger scale bioprocessing, an important consideration to support the large and growing population in Asia.

Single-use technology is still a new industry. Chromatography and perfusion stages are still widely dominated by stainless-steel equipment and although there are new products being released regularly, some stages of bioprocessing simply cannot be carried out as effectively as they can with a stainless-steel system.

PURPOSE OF SINGLE-USE

When you get to the heart of any pharmaceutical business, the very reason for being is patient care and to produce high-quality treatments as consistently and inexpensively as possible. With this focus in mind, the design of a bioprocessing plant should look at all available technology in order to achieve this goal. That’s the place of single-use technology: one choice in each element of the process.

Stainless steel isn’t a dead or dying industry. The equipment still works and provides the most effective solution in many situations, including large pharmaceutical applications for over-the-counter active pharmaceutical ingredients (API) and human vaccine production. These big brothers of single-use systems scale from 10 – 30 kilolitres and have the capacity to keep pace with market demand. You will have to clean, sterilise and validate the equipment, but this may well prove to be less expensive than ripping out and disposing of all equipment every time you run a new product - even for CMOs.

We are encouraged and enthused by the recent innovative developments in the stainless-steel industry, some of which have taken inspiration from the fast-moving single-use space. We are already seeing the use of new materials that extend the life of diaphragms and gaskets and increased focus on new products that eliminate the risk of contamination and reduce maintenance time, such as ASEPCO’s Weirless Radial Diaphragm valves.

In fact, ASEPCO is investing heavily in its stainless-steel bioprocessing technology, demonstrated by the opening of a new location in Milpitas, California. The plant has a dedicated research and development department as well as a sanitary products training centre.

 We firmly believe that we will see a hybrid bioprocessing future, where tried and trusted stainless-steel systems are seamlessly integrated with single-use technology.

This flexible approach will enable CMOs and biopharmaceuticals alike to find the ideal solution for their therapeutics in the best of both worlds.

We see this already in sampling systems, where a customer may use single-use sampling bags with a stainless-steel valve. The customer reduces the cost of the single-use sampling system, which might only service five sampling bags, by using a semi-permanent one.

Stainless steel is not dead nor dying, but the emergence of new technology continues to shake up the industry, calling on engineers to be more creative, to pave the way for smarter, more personalised manufacturing techniques and, above all, to develop more effective and inexpensive therapies.