Cell and gene therapies (CGTs) work by modifying a patient’s cells to prevent, treat, or even cure certain diseases. This is done through replacing, inactivating, or introducing genes into a patient’s cells. These therapies enable treatments tailored to an individual’s genetic profile, bringing new possibilities for conditions once thought untreatable. Despite this promise, biotech companies encounter numerous obstacles in developing and producing CGTs. 

Industry Challenges  

CGT manufacturing and production is inherently complex. Each therapy is designed specifically for a patient’s unique genetic makeup, creating a long and costly journey from discovery to commercialization (sometimes spanning more than 17 years).  

There are also high levels of supply chain complexity. CGTs require cryogenic handling and storage, needing cold chain monitoring and real-time tracking. Regulatory compliance in these areas is also extremely important and difficult for biotech companies to monitor. Additionally, with the collection of highly sensitive patient information, companies must ensure that the data is handled and stored properly and securely.   

To bring these life-changing therapies to patients faster and more reliably, biotech leaders are turning to digital solutions like SAP. SAP solutions for cell and gene therapy can help organizations bridge the gap between scientific discovery and commercial reality, advancing both innovation and patient impact. 

SAP Solutions for Cell and Gene Therapy  

SAP Cell and Gene Therapy Orchestration  

SAP Cell and Gene Therapy Orchestration (CGTO) is a solution designed specifically for improving the development and management of CGTs that comes ready to be integrated with SAP S/4HANA. This solution allows organizations to coordinate every step, from patient identification to order management to manufacturing and quality control to delivery.   

When it comes to the supply chain, SAP CGTO can ensure complete visibility throughout the supply chain. Manufacturers gain access to the full chain of identity (COI) and chain of custody (COC) tracking. Since CGT therapies require real-time temperature monitoring for cryogenic storage, this can be especially helpful in ensuring compliance and facilitating audit and documentation processes.   

Similarly, Clarkston offers a Gene and Cell Therapy Orchestration Platform (CTOP). This solution serves as the data repository for COI and COC data. CTOP works to integrate all the processes associated with CGT into a single platform.   

With SAP CGTO, CGT companies can facilitate integration with manufacturers, logistics, treatment centers, and ERP systems via event-driven data sharing and real-time task management. The settings of this solution can also be configured to support multiple therapies. This can help CGT companies increase flexibility, while simultaneously increasing efficiency.   

SAP Intelligent Clinical Supply Chain Management  

SAP Intelligent Clinical Supply Chain Management is a solution that allows for end-to-end transparency and visibility of clinical supplies. This solution is designed for life sciences companies and can be particularly beneficial for CGT companies in monitoring the supply chain of clinical trials. This solution can integrate with any clinical trial management system or clinical trial management software.   

SAP Intelligent Clinical Supply Chain Management offers demand planning and forecasting tools, helping CGT companies to predict demand and decrease the time between manufacturing to delivery. This solution also allows for intelligent manufacturing and packaging. Companies can manage medication lists for open and blinded serialized trials and perform batch allocation and expiration date calculations.   

SAP Integrated Business Planning & SAP Supply Chain Management   

SAP Integrated Business Planning (IBP) and SAP Supply Chain Management (SCM) are two less specialized SAP solutions that can still be leveraged by CGT companies to improve operations.   

SAP IBP and SCM both offer AI-powered demand planning, which can help avoid production delays. Additionally, SAP’s Transportation Management capabilities can streamline logistics and transportation processes. Both of these features can be especially important for the fast delivery of vital CGT treatments.   

Benefits of SAP Solutions for Cell and Gene Therapy

These SAP solutions can help enhance efficiency, reducing errors and shortening manufacturing times. They can also allow for end-to-end traceability and real-time visibility into the supply chain, ensuring regulatory compliance is met.   

When it comes to supply chain operations, demand planning is particularly challenging for CGT companies because of the personalization, short shelf life, and tightly controlled COI and COC required for these products. SAP solutions that are designed to assist with reducing manufacturing complexity and time can be particularly valuable to CGT companies.  

SAP also provides central data storage to keep all information connected, while maintaining data privacy and protecting patient information. This central data storage makes it easier to connect all stakeholders, including healthcare providers, logistics partners, and manufacturing sites, to increase communication and ensure each party is receiving the proper information.   

Looking Ahead

Digital transformation is redefining CGT manufacturing, driving new levels of efficiency and agility. By investing in SAP solutions for cell and gene therapy today, organizations position themselves to harness the power of AI and predictive analytics in future collaboration with SAP. Connect with us today to chat more. 

Contributions from Natalie Pollock