Tackling the Cell Therapy Supply Chain
Holistic Supply Chain
It seems like we hear about supply chain woes every day on the news. From empty grocery store shelves to computer chips, to flowers for Valentine’s Day, the ability to move goods along the production line is increasingly difficult.
The need to navigate cell therapy supply chain challenges effectively and efficiently is nothing new, however. Since the inception of this remarkable field of therapeutics, the brightest minds in the field are envisioning a seamless journey from collection, whether autologous or allogenic, to final dosing. Cell therapy companies must do their homework and be diligent about all aspects of the supply chain. I was recently interviewed about the supply chain challenges facing the field and my perspective on how they can be resolved.
The bottom line is this – the view must be holistic. There’s not one step in the cell therapy supply chain that you can shortchange; if you do, you run the risk of the entire chain collapsing. Let’s take a look at some particularly vulnerable places in the continuum.
Chain of Custody and Chain of Identity
One of the biggest challenges is the documented maintenance of chain of custody (COC) and chain of identity (COI). COC is a trail of accountability that ensures the physical security of the product throughout its journey. It defines who handled the collection and what was done with the patient material, when it happened, and where it ended up. COI is the permanent assignment of a unique identification to the starting patient material that follows it from the time it’s collected, through to the producer, into the resulting drug product, and then into the patient. In many cases, COC and COI are manually tracked which is a slow process and prone to error. One solution to the COC and COI imperative is automation while another is having more companies specialize in end-to-end logistics.
In addition to the need for better and automated COC and COI, the sheer number of suppliers along the value chain that must be managed can present a complex challenge to the product sponsor. Many companies simply don’t have the bandwidth or the processes to deal with this daunting ecosystem. The supply continuity of equipment and consumables remains difficult and like many other products, has been affected by the pandemic. Supply is short and lead times are long.
A common denominator that can help address many supply chain challenges is automation enabled by purpose-built track-and-trace and logistics software. The more that can be automated, the less a cell therapy innovator needs to manage in a hands-on fashion. There’s less data to deal with and fewer supplier interactions. Software also helps with the track and trace for COI and COC. Our system at Lykan allows us to immediately trace product from incoming to outgoing back to the patient through software. This allows us to prove to ourselves and regulators that robust control is maintained over the material throughout the process. Innovation in production equipment and packaging science is also an imperative for the industry. As equipment providers develop equipment that is more closed, processes are easier to manage and become more efficient.
I’m excited to see the advances being made in support of cell therapy supply chains. The industry is making great strides in the area of automation with the adoption of manufacturing execution systems (MES) and enterprise resource planning (ERP) systems. Industry collaboration groups are forming to explore these issues with a goal of standardizing platforms.
At Lykan, we’re helping emerging and established companies facilitate the end-to-end process. For example, we work with an innovator in MES that has customized modules and platforms for cell therapy, making track and trace much easier. We’ve also established a robust supplier qualification program. We can manage all of this for cell therapy companies overwhelmed by the number of suppliers they need to engage. They deal directly with us, and we oversee their network of suppliers and other service providers.
The future is bright for cell therapies. The field continues to evolve, reaching a greater number of patients. Cells are being engineered in novel ways to deliver a more potent therapeutic effect while different types of immune system cells are being explored to minimize side effects. In parallel, it is incumbent upon manufacturers and contract development and manufacturing organizations to put in place processes, automation, and safeguards to strengthen and protect the supply chains upon which success of this industry relies.