You want to know what an oyster has to do with higher returns in the biopharma industry?

It all starts with a grain of sand that by chance found its way into the oyster. The grain of sand is an annoyance; it poses a problem. The oyster feels disturbed so it deals with the intruder. But how does the oyster go about it – how does the oyster save its problem?

It starts to cover the intruder with the material of its own shell. This leads to the grain of sand growing bigger and bigger until it finally turns into a pearl that is embedded in the soft interior of the oyster and protected by the almost unbreakable mother-of-pearl shell.

At least this is what the theory tells us about the formation of pearls.

If we now take a look at the business world or a process chain, we will often find issues or areas that remind us of a disturbing grain of sand. It might even be an untoward risk that is seen as a threat or as “disruptive”, almost like a bottleneck that obstructs scalability as well as production output. It might be something as simple as an underdeveloped process area.

There are only very few companies that understand how to turn their obstacles into pearls. In terms of the biopharma industry, the logistics process for liquids poses such a “problem area”; underdeveloped processes are the reason for substantial substance losses caused by offsets or bio contamination, which in turn cause annual financial losses into the millions.

So what does the biopharma industry have in common with an oyster?

To date, biopharma companies were hardly able to offer a failsafe logistics process for highest-quality liquids.

Shipping requirements, for instance in airfreight, demand a lot from containers and packaging. Shipping processes and international logistics are usually fast-paced and “rough”. There is hardly any other industry where the claim “time is money” is more appropriate.

Furthermore, biopharmaceutical substances often have to be shipped either frozen or cooled. A disruption in the freezing chain usually causes a total loss of substances. Damages that amount to several million Dollars are not uncommon.

With all its advantages and disadvantages, the often used single use bag constitutes an industry standard for varying filling quantities.  As long as you are aware of its weaknesses and have in place a compensation strategy for these weaknesses, the single use bag is the perfect container.

The alternative would be bulky multiple-use stainless steel tanks (also known as CryoVessels) that are expensive, big, and take up a lot of space. In other words, once drained, they have to be shipped back to their origin, which causes substantial costs.

Additionally, cleaning causes high costs, requires the use of chemicals and an enormous amount of water. We do not even want to mention the possible risks in case of improper cleaning.

Single use plastic bottles are another alternative to single use bags. As they are often open, the handling of plastic bottles is risky. There are no satisfactory isolating solutions for the shipping of mostly cooled or frozen goods in bottles. Furthermore, bottles are an only moderately satisfactory solution in terms of connectors, filling and draining, plus they require a lot of storage space, even when empty, all of which does not apply to single use bags.

The undisputed advantages of single use bags

The advantage of single use bags is obvious: During the freezing process, they simply grow with the expanding liquid, while they hardly require any storage space when not in use. They are lightweight, flexible and compatible in terms of hose systems and filling.

The disadvantages of single use bags, on the other hand, are obvious too: Due to their flexible nature they are sensitive and prone to material deficiencies.

These two issues – the skin’s vulnerability and the risk of leaks in medicinal single use bags – posed a challenge for Thomas Wurm and Johannes Kirchmair, two young entrepreneurs from Austria.

A problem is no longer a problem once you have a counter-strategy.
The oyster clearly has a counter-strategy for its problem. In relation to its size it lives with a relatively big, albeit desirable foreign matter but we can assume that it found a satisfactory agreement.

In 2015, Thomas Wurm and Johannes Kirchmair founded SUSupport (Single Use Support) in order to offer their own counter-strategy.

Counter-strategy 1:

RoSS – die Single Use Bag Hardshell

With their core product “RoSS®, a shell that embeds single use bags in soft foam on the inside and protects them with a plastic frame and stainless steel elements on the outside, SUSupport solve the problem of the sensitive skin of single use bags. The RoSS® Shell is produced and precisely fitted for all established brands like Thermofischer, Sartorius, GE, Meissner, Pall or Merck Millipore
.

Attempts by single use bag manufacturers to launch cardboard or polystyrene systems have not proven very successful, as they are not an ideal solution.

 

Counter-strategy 2:

MITS.2D - Single use bag integrity testing system

MITS.2D – Single use bag integrity testing system

The fact that single use bags are very likely to exhibit material deficiencies that can lead to bio contamination of the content is
addressed with MITS.2D®, a single use bag testing system. With the patented MITS.2D® System, single use bags from all established manufacturers with a capacity of up to 50 liters can be tested with regards to leaks and functionality in less than a minute.

Side effects of SUSupport’s research work

The clever material mix that is used for the construction of the RoSS® System not only allows for secure handling and maximum protection of the bags. (zusammensetzt ermöglicht neben sicherem Handling und maximalem Schutz der Beutel für den Transport, weitere positive Effekte – Komma nach zusammengesetzt, kein Komma nach Transport) The cassette-like design also facilitates compact storing and shipping of the RoSS® Shell Systems. The stainless steel tops and bottoms are in direct contact with the bag and its content, which thus can be cooled and thawed quickly and effectively. Furthermore, the RoSS® elements can be easily recycled or reused.

 

Conclusion:
Use all advantages of single use bags – like compatibility, flexibility, their tried and tested application – and compensate their disadvantages with the undisputed characteristics and troubleshooting experience of the oyster:

A compact, tough shell, a soft and flexible interior and the knowledge of how to deal with high-quality contents.

And this is what the biopharma industry can learn from the oyster: How losses caused by leaks, mechanical influences and material deficiencies caused during the logistics process for liquids or drug substances, or caused by bio contamination, can be reduced towards 0%.

Find out more about the RoSS® Shell and the MITS.2D® Single Use Bag Testing System.