Supply Chain

The role of technology for Bio Pharma – Part III

The third article about the role of technology for Bio Pharma outlines the level of clinical trials, the need for a defined manufacturing strategy, the importance of sustainability and introduces revolutionary a cold storage solution.

Edin Osmanovic
Head of Supply Chain Solutions DACH

The number of clinical trials has reduced to pre-pandemic levels

According to the World Health Organisation the number of clinical trials in progress has started to decrease and is now more in line with pre-COVID-19 levels. However, this could very easily switch course again and it is therefore important for organisations to always undertake cost-to-benefit trial calculations.

For those trials where there are high expectations, the advice is to consider having internal teams working on these initiatives so that knowledge is retained within the business, and outcomes can be closely managed. The different phases of clinical trials vary enormously, now even more than before COVID-19, and organisations can wait a long time for data and results from all their patients. Once back, results are analysed to understand if there is potential for a drug to work. To test the efficacy of a drug, the Bio Pharma company needs a certain amount of raw material, and they must also adapt material based on any feedback.

Clinical trials tend to be increasingly global and different genetics and nationalities can play a role and affect the results. Costs are huge and Bio Pharma companies must plan for a certain percentage of failures. This was always the case, to some degree, but the pressure on the process has increased, according to the participants in the roundtable.

What is hard to calculate is that if they don’t reserve space with CMOs they might not obtain the material they require. Some CMOs demand that manufacturing slots are booked one year ahead of time and, if this is not reserved, then the organization won’t make its drug trial. This is where a good relationship with the CMO to respond quickly is imperative.

Clearly define your manufacturing strategy

As mentioned above, a big hurdle in the supply chain is having the material available when it is needed. If the organisation is not in charge of its manufacturing and is dependent on a CMO to make their material this makes it very difficult to manage.

Unfortunately, Bio Pharma companies need to produce the same product for a clinical trial for 500 patients as they need for that product to be sold commercially and mass produced for five million patients. According to one participant: “You know that the product can be stopped at any time in between those two moments. This means you do not want to invest in a facility, in the first instance, that can produce for five million patients. On the other hand, you do not want R&D to develop a process that you cannot scale.” Here, it is important to work with a small-scale manufacturing line. If possible, using a service provider that is focused on clinical trials but can produce for a larger scale further down the line is advised.

Building out the manufacturing strategy and network with alternate sites as back-up is important. It is important to understand what R&D is doing. 80% of the manufacturing network design is defined by R&D and decisions they make will very much limit options in the high-scale phase. In particular, the advice here is to map out the hidden elements of the supply chain. During the R&D phase use technology to map everything out so that there is a playbook for the commercial phase and the organisation knows what to do.

Sustainability is mandatory

When asked how sustainability influences the decision-making process and what are participants’ long-term sustainability initiatives, everyone agreed that sustainability must be mandatory.

In the future, all agreed that it is important to utilise digital solutions that help map out a proactive and reactive sustainable supply chain strategy. For example, why isn’t every vial reused – rather than thrown away in hospital? Could it be manufactured for reuse? Here, the circular economy and technology that enables sustainability become very important.

Circular management is important, and the industry needs to judge and balance when it makes sense. To achieve this, data is absolutely critical so that service providers, and production suppliers can all remain informed. This will become an absolute requirement in the future and by natural selection the ones who are not acting sustainably will be left out of tenders.

Cold storage remains a challenge

Cooling remains a big challenge for the industry in terms of how to make it sustainable. However, the VIXELL reusable cooling box with innovative insulation can be a starting point. The box is not only recyclable but features ice packs to reduce the use of dry ice, a hazardous material that requires special safety measures. Instead of simply selling cooled boxes, we have introduced an international deposit system that incentivizes pharmaceutical manufacturers to ensure boxes are returned for subsequent use.

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Supply Chain

Sustainability is mandatory

Cold storage remains a challenge

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