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What Covid-19 shortages have taught us about security of supply.
What Covid-19 shortages have taught us about security of supply...
This Covid-19 pandemic has exposed a number of frailties in the supply of protein A resins to the biopharma industry. As attention is naturally drawn to the development of a new vaccine to tackle the virus, many companies are now finding it difficult to secure protein A resins for their therapeutic Covid-19 processes and also for non Covid-19 related processes due to unprecedented demand and governments invoking rights under national emergencies, as seen recently with USA DPAS (Defence Priorities & Allocations System). For even the largest resin suppliers, this has left many unable to meet the needs of their customer base, leaving even the highest value companies waiting as long as 12 months for their resins. This raises an interesting questions in the midst of the ongoing pandemic across the globe - what role does customer loyalty play in securing your supply chain during challenging global conditions?
In this article we look at the effects of customer loyalty during the pandemic when measured against the importance of effective supply chain management for the global biopharma industry We hope that this offers advice and guidance in making necessary improvements to secure your supply chain.
Customer loyalty during a pandemic
Suppliers showing loyalty to their customer base has always been paramount, however with unprecedented demand being placed on even the largest businesses globally due to Covid-19, many suppliers with diverse product portfolios have in the end been unable to supply. Ultimately what we have seen is governments in certain countries exercising their power to make decisions over the supplier on which orders to serve and allocate, as has been seen in the case with DPAS. Regardless of how long the customer has been loyal, how large they are and the revenues they contribute to the supplier, customers who've trusted a single supplier for many years, suddenly find themselves with prohibitive lead times on key raw materials, delaying their own production processes and ultimately hindering access to vital medicines. Worst still, it means that these vital medicines are not being supplied to patients.
Suppliers having issues meeting the demands of all their customers will have to prioritize the customers they supply. Although this may be necessary for their own business operations, it means bad news for their customers that still require their product.
Although choosing to prioritize larger customers is not inherently negative, or even unexpected from a business perspective, it will of course have a negative impact on those companies that do not fit these criteria. Early-phase customers are reporting lead times of 8 - 12 months for their protein A resin supply, adversely impacting their own processing goals. Some have been refused supply unless they can demonstrate the materials will be used for commercially approved processes or Covid-19 related processes.
The consequence of remaining a loyal customer during a pandemic can have an adverse impact on your processes being able to function as usual. In their paper 'Resin Sourcing', Duncan Low & Brian Hubbard (consultants to the biopharma industry with Director-level experience at Amgen, Millipore and Immunex Corp) express that resins are a primary agent for purification and frequently considered critical, so change is encouraged in response to unplanned events.
Our recommendation is that companies in these situations should review their supply chain and prioritize the ability to be able to dual-source all their key raw materials, like for instance their protein A resins. This approach to supply chain management will mitigate the risk of being negatively impacted by another inadvertent event.
"Some of the new technologies show performance comparable to current industry standards and there is the opportunity to reduce the risk of reliance on a single source for critical materials"
'Resin Sourcing', B. Hubbard. & D. Low (2019)
Creating a secure supply chain
The issues raised under customer loyalty during this time strengthens the need for companies to create a secure supply chain. Ensuring the supply of essential materials like protein A resins are not disrupted is of paramount importance for future operations. A study conducted by BioInformatics Inc (https://bioinfoinc.com/?new=www.gene2drug.com) found that the primary reason scientists contact a company's customer service department was because of failures in supply.
For companies to future-proof their processes, research into new resin suppliers is crucial. We highlight some key areas to focus on when building a case for a more secure supply chain. The below figure is taken from 'Resin Sourcing' and highlights the key risk categories to ensuring a secure supply.
Figure 4: Risk categories for materials for biopharmaceutical raw materials.
Click the image to view in full size.
Capability of supplying required amounts
A main cause of the supply issues companies are facing due to this pandemic are because their supplier is not capable of supplying the required protein A resin amounts. This is an important questions to ask of your current supply chain when sourcing a new supplier. The current global demand for protein A resins is approximately 80,000L.
This should already be a prerequisite of all suppliers, but Covid-19 has highlighted the different ways in which countries respond to a pandemic situation causing a disparity in supply logistics. Selecting a supplier that operates nearshoring is a great solution to ensuring a secure global supply to customers in key locations.
The impact of Covid-19 on the protein A resin industry
Here we outline the main factors impacting the protein A resin industry as a result of Covid-19. This pandemic has uncovered shortcomings in the supply of protein A resins that need to be addressed if customers are to be able to operate more efficiently and to mitigate the risk of being affected by a similar event in the future.
The increased demand for protein A resins has created supply shortages in the biopharma industry and many suppliers are unable to offer immediate access to their protein A resins. As Hubbard & Low highlight in 'Resin Sourcing', continuity of supply is a concern to ensure that processes are kept moving.
Long lead times
Industry supply shortages are creating lead times of up to 12 months for protein A resins and customers who have placed their trust in a single supplier are now experiencing delays of their own production processes, regardless of their loyalty.
Providing critical supplies
Supply shortages are creating longer lead times which in turn is impacting the delivery of critical supplies to the industry. The accessibility of medications and other essential supplies have been impeded as a result of the increased demand for protein A resins.
Purolite's commitment to security of supply
As a leading supplier of resin media to the world's most regulated industries, ensuring reliable availability of resins is vital to our customers and of paramount importance to Purolite. Purolite is a critical supplier to the food, drug, medical, water and power industries, so has a real-world and robust security-of-supply system in place to support your process requirements for business continuity.
Ensuring security of supply for all...
Having recognised that the protein A resin supply industry is dominated by one supplier and that the security of supply currently in place has proven to be unsuitable, Purolite is expanding its manufacturing capabilities to address and fulfil the increasing global demand for protein A resins by building a new agarose manufacturing facility equipped with proprietary jetting technology. This expansion means we are the only manufacturer to have two different manufacturing sites in two different continents, giving us a more robust global distribution. This comes as part of our commitment to securing supply to critical markets and ensuring we can support the growing needs for new medical applications and future drug development. Our US facility will give us an increased capacity of 280,000L, capable of providing a guarantee of more than 500L in a matter of weeks. We will be capable of matching the current total supply available from other manufacturers from our US facility alone. We have a large volume of capacity available to meet very short lead times and we are committed to fulfilling these orders faster than other suppliers.
View our latest news release regarding our US expansion.
Our field-based Technical Specialists and R&D teams are always on hand to offer guidance on both selecting the best Purolite resin and achieving optimal results with your product. We also support customers with a range of technical support services including column packing support.
Purolite is the only globally-active company focused solely on advancing resin-based separation, purification and extraction technologies. Whereas other suppliers are manufacturing more than 1400 types of media within their facility, our focus is exclusively on our resins.
To minimize potential impact to our customers, Purolite continually invests in facilities, processes and equipment to ensure that our locations, products and services - as well as those of our suppliers - are unaffected by disasters, emergencies and potential incidents.