Scaling the CGT supply chain: from clinical to commercial

Even though there are currently five approved CAR-T products in the market, the industry is still in the early phase of development and a number of key challenges for industrializing advanced therapies have not yet been addressed. One of these challenges is to manage and scale the CGT supply chain and manufacturing operations across the globe for an individualized treatment.

During the Binocs User Meeting in October 2021, we hosted a panel of experts in the field to highlight the current challenges in scaling up interconnected supply chain and manufacturing operations for CGT products.

In this whitepaper, our panel of experts will explain:

1. Introduction

Cell and Gene Therapy (CGT) products are addressing critical unmet medical needs, particularly for patients suffering from cancer and gene-related diseases. However, while CGT holds great promise, the industry faces significant challenges in scaling supply chains and manufacturing operations for individualized treatments.

As the industry matures, optimizing the entire supply chain—starting from demand planning to scheduling and manufacturing execution—becomes essential.

2. Scaling the CGT supply chain from clinical to commercial

The transition from clinical to commercial operations for CGT companies requires rethinking IT and manufacturing strategies. Companies often struggle with integrating various systems, such as ERP, LIMS, and MES, which were often added piecemeal during the clinical phase. A forward-looking approach is essential to avoid issues during commercialization.

Additionally, companies need to understand that CGT does not follow the typical distinction between clinical and commercial phases seen in traditional pharmaceuticals. Shared resources and careful planning are required to handle the unique challenges of CGT.

3. Integrating data systems

Effective CGT supply chain management relies on integrating various data systems and platforms. Rather than attempting to build a monolithic system, companies should decouple different layers of functionality—such as business operations, orchestration, and manufacturing systems.

This allows for specialized software to handle specific tasks more efficiently, while establishing a common data model across all platforms is critical to achieving smooth integration and avoiding inefficient transformations in middleware.

4. Managing capacity and variability across the CGT supply chain

Capacity management is a key challenge for CGT companies, particularly when coordinating between internal manufacturing sites and external CDMOs. The unique nature of CGT treatments, where one patient equates to one batch, makes scheduling and capacity management more complex. Companies must account for variability in manufacturing and plan for disruptions.

Utilization of capacity is often low due to built-in buffers that are required to accommodate potential delays, thus increasing costs. By decoupling capacity planning from detailed scheduling, the entire CGT supply chain can be more flexible and end-to-end resources can be optimally allocated.

5. Communication and automation

Effective communication is vital for managing the CGT supply chain, especially as operations scale. Automating communication, both upstream and downstream, can help reduce the burden on manual processes and improve overall efficiency.

However, balancing the level of information shared with partners, such as CDMOs, without overwhelming them with updates, is crucial. Automation should extend beyond just the logistics of today’s operations to predicting future events and optimizing for potential disruptions.

6. Future trends in the CGT supply chain

As the CGT industry continues to mature, standardization and industrialization will become increasingly important. The industry can benefit from adopting practices and technologies from other sectors, particularly around supply chain management and scheduling.

Although full standardization of the end-to-end CGT process may be years away, companies should focus on standardizing what they can today, particularly in areas outside of the manufacturing process. This will help reduce costs and increase flexibility in other areas.

7. Conclusion

Scaling CGT supply chains from clinical to commercial requires overcoming a variety of challenges, from system integration to capacity management and communication. Digitalization and automation play a crucial role in ensuring these complex operations can scale efficiently, ultimately improving patient outcomes.

Effective interoperability and communication across different platforms will be key to the future success of CGT companies.

Binocs is already a trusted partner in a range of CGT projects: