Shift to single-use technologies leads to massive supply-chain delays

As there is an upward trend to single-use technologies, strategic thinking and the courage to change up processes are called for in the pharma industry.

The pharmaceutical and biopharmaceutical industries are seeing a major shift to disposable technologies. However, this shift and the introduction and advance of personalized and allogeneic therapies are currently leading to massive supply-chain delays in terms of single-use consumables. The shortness of supplies is further being fueled by the ongoing Covid-19 pandemic. While there is an obvious general increase in demand, of late most of the supply has been delivered to meet any Covid-19-related needs. 

This causes what some experts may call a “triage of single-use systems and consumables”, and is exacerbated by understaffing due to lockdowns or quarantine requirements. The result is an even more intense shortage of materials and leads to new considerations in supply-chain management especially in the cell and gene area. The resulting delays cause shortages that are proving to be a real challenge. They are calling for both strategic planning and rapid responses of all parties involved. Only by thinking strategically and ensuring replenished stocks will the industry be able to deal with the current crisis and provide a long-term solution for this weak spot. 

The problems caused by global supply chain delays

As one of the results, the backlog in manufacturing affects the supply of potentially life-saving medication to the patient. Cell and gene therapy (CGT in short) is a new and promising type of immunotherapy for patients suffering from certain types of cancer and lymphoma/leukemia. It is a complex and elaborate process that involves the extraction of the patient’s autologous cells for further treatment. The applied processes and technologies are customized to meet the needs of the highly sensitive and valuable human cells and genes. Single-use has proven to be the technology of choice as it allows for flexible and scalable platforms and solutions.

And this is why a shortage in consumables can lead not only to major setbacks, but also to huge financial losses. This is a grave state of affairs that must not be taken lightly. It needs to be solved rapidly and permanently, which is only possible by ensuring a steady and rapid supply, even in times of increased demand. So far, pharmaceutical manufacturers have been used to linear setups. But - this will have to change: It may be initially difficult to implement (and get used to) emerging interorganizational digital platforms to facilitate and orchestrate all stakeholders in real-time. However, there will be no way around this for any player wanting to remain relevant and successful.

How to solve the seemingly unsolvable

But how can steady and lasting supply be guaranteed, especially in the light of the aforementioned capacity constraints? Looking at the reasons behind the supply-chain delays, it seems we are looking at solving a seemingly unsolvable problem. However, with the right approach and attitude, there is no such thing as “unsolvable”. Though, it may be necessary to rethink established processes. This may also include having to rethink principles and fundamentals that so far seemed untouchable. It is the only way to ensure sustainable and lasting success.

Strategic planning

It has become quite clear by now that strategic planning is critical - including order and stocking management. Multiplying production area, expanding clean room capacities and building up a large stock of single-use assemblies is key to avoiding bottlenecks and being able to supply manufacturers worldwide. As important as those steps may be, one of the most essential factors is the collaboration between manufacturer and supplier.

Syncing supplier and manufacturer goals

Implementing the most elaborate system will prove to be fruitless if the parties involved don’t communicate and/or pursue different goals. Therefore, the first step to a successful supplier-manufacturer relationship is to sync individual goals. It is of utmost importance that the goals of both, supplier and manufacturer are clear from the beginning and everybody has to know their part.
Furthermore, a schedule containing set timelines, which are manageable for both sides, should be in place. 

“There’s a clear necessity to set realistic timelines and adhere to the planned schedule for both sides,” Barbara M. Fischer, Process Consultant at Single Use Support 

But, as with all relationships, it can be difficult to maintain a good and healthy collaboration, especially in the pharma industry where technological developments and novelties are adopted quite slowly.  When it comes to the technology being used, manufacturers and suppliers might not be on the same page, which can lead to errors and delays.

This is why even long-standing collaborations may have to be questioned, preferably at the start of the change process. 

Automated inventory processes

Accepting the status quo should never be an option, meaning that neither supplier nor manufacturer should be afraid to try new approaches in order to ensure consistent, reliable and fast supply.

Even established providers of single-use systems like Single Use Support face the challenges of balancing strategic planning and rapid response. But to ensure lasting stocks of single-use assemblies and systems items like bioprocess containers, organizations must plan several steps ahead. Current global shortages and supply chain disruptions demand nothing less.

In this regard, it is important to implement modern processes and digitalization procedures, like automated inventory processes. Those are helping manufacturers and suppliers in managing their inventory in real-time. As automation itself is one of the core objectives of Pharma 4.0, automated inventory processes underlay those new approaches and digitalization. 

Single Use Support is therefore using RFID tags (radio-frequency identification tags). Those are tags that can be attached to all physical products of the manufacturing process and facilitate digitalization. Consequently, data of all sorts can be collected, stored and shared with collaborators in order to be on the same page. Additionally, various products can be connected to each other and interact. 

The implementation of Pharma 4.0 approaches further allows AI-driven data analytics to optimize workflows and enables full lifecycle tracking of products. To implement approaches of Pharma 4.0 allows the facilitation of seamless full lifecycle tracking and AI-driven data analytics to optimize workflows.