A Roundtable Discussion
Informa’s BioProcess International US West conference in 2022 contained an interactive panel discussion on the security of the supply chain. Dominic Moore (Sanofi - the Global Lead for Raw Materials Supply) moderated Christine Callahan (Thermo Fisher Scientific - VP of Global Supply Chain), Ilir Koliqi (Tosoh Bioscience - Sales & Support Director), Chantay Erickson (Bionova Scientific - Head of Supply Chain Management), Vikki Ponting (Cytiva - Security of Supply Manager), and David Radspinner (ILC Dover - President of Biotherapeutics) as they discussed the supply chain.
According to Dominic, there is still a lot to do to secure the supply chain for cell and gene therapies. The panel generally found communication to be key. Sanofi now works much closer with their suppliers providing better visibility, better regulation and together achieving transparency of interaction.
At Thermo, Christine Callahan found that transparency was boosted by more frequent communication moving from monthly business reviews or supply and demand discussions to daily postings between their suppliers.
For us, it has really been a transforming time for how we collaborate with customers
According to Ilir Koliqi, the relationship between Tosoh and its suppliers has become more like a partnership than a transaction-based relationship.
This has allowed us to really adjust and work with our planning and supply teams over at our production facilities to be able to react facilities to situations a lot quicker with the relationships that we have been created with the customers.
Vikki Ponting added that working with suppliers to mitigate risks, add capacity, and work with business continuity to make sure that the facilities are capable of that capacity expansion.
Koliqi noted that Tosoh had taken a proactive approach to supply chain security by improving the efficiency of their in-house processes. They managed to purify 2 kg of MAb from 200 L of feedstock in four hours using only 4.7 L of protein A instead of the usual 100 L. Companies in the cell and gene therapy space need to ask themselves: In the future, how are we going to mitigate risks of needing 500,000 L of resin at the drop of a dime?
Cytiva has implemented ISO 22301:2019 security and resilience, and business continuity management systems. This standard specifies the requirements to implement, maintain and improve a management system to protect against, reduce the likelihood of the occurrence of, prepare for, respond to and recover from disruptions when they arise. Ponting feels that this helps reassure suppliers and other companies of the steps that Cytiva has taken to mitigate risk.
The panel consensus was that over the last couple of years smaller suppliers have become more important. More relationships have been built and to a certain extent, there is now more competition between the suppliers in terms of what they can provide. On the cell or gene therapy company side of things, they have become more active in bringing different suppliers together to negotiate and perhaps get a job done that neither one could perform on their own, but with pooled resources can complete the job. Negotiations may even include the Biomedical Advanced Research and Development Authority (BARDA). The CGT company acts as the arbiter of those deals with itself being the benefactor and providing opportunities for the smaller suppliers.
David Radspinner is seeing a lot more creativity. A lot of creativity over alternative materials, partial shipments, early shipments, late shipments, just a lot of methods of doing business that in the past would not have existed. Shifting capacities have also become challenging. For example, with fixed budgets, the labor force may be optimal, but the equipment is lacking. On the other hand, to bring in new automated equipment you may have shed some of your most experienced people that can no longer take the lead when exceptional circumstances arise. Transparent communication may be the only way to keep a lid on these issues.
The panelists agreed that having a region-to-region strategy for different materials is important. The pandemic has meant that it is often not possible to travel to different facilities to audit the processes. Ponting suggested that many customers do not want to take the extra effort needed to validate materials from new sources. Given the new normal that has emerged out of the pandemic, it may be in the interests of customers to start to be willing to take those extra validation steps.
Cytiva takes a parts approach to source materials by capturing 40 different attributes around that part, financial health, GDP, geographical location, quality history, and business continuity. All that builds into a score that takes you down through the sub-tier suppliers, where you can get that information. For critical raw materials, Cytiva has mapped the supply chain right down to the very starting points for the raw materials.
Koliqi sees an end to the days when production platforms relied on source materials, say resins, from a single company. Supplier loyalty will fade in favor of faster turnarounds, Thermo and better outcomes for patients.
For us, there is a lot redesign of what we call our network now, and enabling that network and not just building sites as we would done in the past
The panelists shared that five- to ten-year forecasts of what materials will be important are becoming more prevalent. A lot of suppliers are now asking for the forecasts to stay consistent. Some organizations such as Bioforum have specific forecast demands. It is short-term operational forecasts versus long-term investment type forecasts.
In Christine Callahan’s view “we need to take some risks and mitigate risk, that’s not natural for anybody, but that’s really where we are and you have to kind of try to do alternative or try to secure a small supplier, or whatever that may be and will that allow you to mitigate. So we talk a lot about the known risk, the new risk, and the old risk. We have actually managed to segment risk within our risks to try and understand where we take those bets.”
Raw materials make or break the commercial success of cell or gene therapy. If any one of the raw materials used during the manufacture of a CGT becomes unavailable, a potent therapy will be a commercial failure. Critically, product CQAs are defined based on the reality of the forecasted raw material supply and demand in the long term. Under certain circumstances, it may be preferable to compromise CQA attributes to create a commercially sustainable product, rather than a miracle drug that material resources will only sustain for a limited time, as opposed to the lifetime of the intellectual property. The COVID-19 pandemic has spurred viral vector manufacturing innovation and increased capacity that will benefit cell and gene therapies in the future. It has also put a strain on the traditional supply chain. The pandemic has also inspired creative ways of maintaining the CGT supply chain. It appears that the CGT industry supply chain is unlikely to return to the status quo following almost three years of the COVID-19 pandemic.
We've had to change, our suppliers have changed, everyone's had to change, and some of this is going to stick around. These are new ways of working that do work; let's see how it goes in the future.
