The collaboration has resulted in a secure and reliable combination of TrakCel’s cell orchestration platform OCELLOS and Lonza’s manufacturing MODA-ES platform. The integration between OCELLOS and MODA-ES will mean that critical manufacturing steps, checks and data flow directly into the Chain of Custody and Chain of Identity within the CGT supply chain, without the opportunity of being missed or not connecting with the patient journey. This will help developers gain additional visibility and control whilst reducing product loss, delayed treatment, recalls and poor-quality product. TrakCel and Lonza have just completed proof of concept integration work. As a result, the combined solutions are available to the market immediately.
The integration is the latest part of an ongoing collaboration between TrakCel and Lonza. This collaboration involves a multi-phase roll out of connectivity with OCELLOS to other Lonza systems including SAP, and LIMs. As a result, TrakCel has anchored OCELLOS into a central position of a fully integrated orchestration eco-system. Other integrations are set to follow the MES proof of concept and are likely to be completed in the second half of 2023.
These future integrations will allow OCELLOS users to pull even more of the information or documents required to drive processes or support Chain of Custody and Chain of Identity directly into OCELLOS in real time. Integrations such as this allow TrakCel’s CGT supply and value chain customers to configure a network of systems to best meet their processes.
“The flow of cell and gene therapies towards commercialisation is continuing to increase in number and speed. It is essential that the supply and value chains continue to keep up with the demands for serving patients after therapeutic approvals and commercialisations. Efficient resource utilisation will be essential to streamline the costs of bringing these therapies to market,” said Dr Fiona Withey, Chief Executive Officer, TrakCel.
“As a result, TrakCel is partnering with a range of organisations that will increase visibility across the supply and value chains and reduce risks as patient numbers continue to increase. The TrakCel / Lonza collaboration will allow customers to accurately track further into the supply chain process than ever before and fulfil a range of tasks to monitor and schedule manufacturing slots and equipment to minimise waste and delays. In 2021, nearly four fifths of biologic recalls were as a result of process step failures or a lack of documentation. TrakCel is working hard to ensure this considerable waste is halted.”
“For the cell and gene therapy industry today, orchestration within the manufacturing component of the supply chain will be essential. Both manual and automated manufacturing of autologous and allogeneic therapies will need careful tracking for considerable patient numbers in the very near future,” said Walter Bagni, Director, Head of Cell & Gene and Labeling CoE, at Lonza. “Integrating our manufacturing platform with TrakCel’s OCELLOS will be the first step in a multi-phase rollout of integrations between Lonza and TrakCel that will further improve adherence to process and critical records and enhance therapy safety and reduce costly errors.”