SAP for Cell and Gene Therapy: 4 Solutions to Consider

Cell and gene therapy (CGT) can help prevent, treat, or cure certain diseases by replacing, inactivating or introducing genes into a patient’s cells. CGT can tailor treatments to a patient’s specific genetic profile, offering hope for treating diseases that were previously considered untreatable; however, biotech companies still face many challenges during the production of these therapies.

INDUSTRY CHALLENGES

CGT production presents many challenges, including manufacturing complexity. CGTs are designed specifically for each patient’s unique genetic makeup. This can create a significant gap between discovery and commercialization, which can last over 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.

SAP solutions can help streamline the CGT process by improving supply chain visibility and traceability and assisting with data management and meeting regulatory compliance.

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, Crescense 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.

Overall, SAP CGTO ensures accurate and timely coordination of patient-specific treatment journeys. 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 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 in CGT manufacturing offers widespread advantages for increasing efficiency. Investing in SAP solutions now offers further potential for leveraging AI and predictive analytics in collaboration with SAP in the future.