Providers of ATMP (Advanced Therapy Medicinal Products) therapies, such as cell and gene therapies and personalized vaccines, require advanced software infrastructure across their entire production process. This enables them to implement digital visibility, automation, and real-time feedback into their technology to ensure management of complex manufacturing and large data volumes as well as complex, high-risk patient safety requirements.
“Our strategic cooperation with Hypertrust Patient Data Care, TrakCel and Vineti empowers biopharma customers to bring life-saving, cell and gene-based therapies to patients in need as quickly and safely as possible,” says Jens Woehlbier, Chief Executive Officer (CEO) Software at Körber Business Area Pharma. “Integrating leading supply chain platforms with Werum PAS-X MES will enable operational excellence and advanced cell and gene therapies out of the box. Our joint solutions will simplify compliance with all regulatory requirements and offer easier, faster manufacturing processes.”
The common approach ensures complete Chain of Identity (COI) and Chain of Custody (COC) visibility and product tracking, as personalized cell and gene therapies go through each step in the manufacturing supply chain. It facilitates standardized data transfer across the pharmaceutical digital ecosystem to ultimately support data management, data analytics, and data science to drive efficiencies in clinical trials and outsourced contract research and manufacturing partners.
With its Werum PAS-X MES Suite, Körber is the market leader in digital manufacturing solutions for the cell and gene therapy industry. Werum PAS-X MES is used by more than half of the world's top 30 pharmaceutical and biotech companies and operates in more than 1000 installations around the globe.
Hypertrust Patient Data Care, TrakCel and Vineti offer leading cell and gene supply chain orchestration platforms to manage the global autologous and allogeneic cell, gene and immunotherapy supply chains. Their digital software solutions – developed in collaboration with the industry – accelerate scale-up and scale-out of cell and gene therapy products.