- The international technology group Körber is driving the integration of supply chain and data orchestration platforms into its market-leading Werum PAS-X Manufacturing Execution System (MES). To this end, the company has entered into strategic partnerships with leading providers such as Hypertrust Patient Data Care, TrakCel and Vineti. The aim is to provide standardized interfaces between manufacturing and logistics solutions to increase manufacturing performance and visibility for cell and gene-based therapies for pharma, biotech and cell & gene companies.
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.
Körber is an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire.
At the Körber Business Area Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions. With our software solutions we help drug manufacturers to digitize their pharmaceutical, biotech and cell & gene factories. The Werum PAS-X MES Suite is recognized as the world’s leading Manufacturing Execution System for pharma, biotech and cell & gene. Our Werum PAS-X Intelligence Suite accelerates product commercialization with data analytics and AI solutions and uncovers hidden business value.
About Hypertrust Patient Data Care
Hypertrust Patient Data Care (HPDC) provides specialized solutions and consulting services to optimize the supply chain of Advanced & Personalized Therapies. Hypertrust X-Chain enables pharmaceutical and biotech companies to set-up, orchestrate, operate and scale-up a frictionless supply chain that ensures highest data security based on latest technology, decentralization and pharmaceutical standards. HPDC products and services support all product lifecycle stages from pre-clinical trials to commercialization. With HPDC’s broad supplier and service provider ecosystem, companies can accelerate the setup of their Advanced & Personalized Therapy supply chain processes. Hypertrust is a spin-off of CAMELOT Consulting Group.
TrakCel is a market leading developer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining treatment collection to administration compliance and traceability. TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey.
Vineti is the first commercial, configurable cloud-based platform to expand patient access to life-saving cell and gene therapies. Vineti was co-founded by GE and the Mayo Clinic to solve the key challenges that patients, medical providers, biopharmaceutical companies, and regulators face in the delivery and commercialization of individualized therapies. Now a fully independent company, Vineti offers a digital platform of record to integrate logistics, manufacturing, and clinical data for personalized therapies. The Vineti Personalized Therapy Management® (PTM) platform aligns and orchestrates the cell and gene therapy process and improves product performance overall. The Vineti platform supports the full continuum of patient-specific therapies, including cancer vaccines and autologous and allogeneic cell therapies. Vineti is currently serving patients, healthcare providers, and researchers in hundreds of leading medical centers and manufacturing centers world-wide, on behalf of a growing number of biopharmaceutical partners. In 2019, the World Economic Forum honored Vineti as a World Economic Forum Technology Pioneer. Vineti is headquartered in San Francisco, California, with offices in Bethesda, Maryland and Yerevan, Armenia.