With immunotherapies playing an ever-increasingly important role in clinical oncology development, Werum IT Solutions and the Blood Centers of America have teamed up to develop a “vein-to-vein” digital supply chain solution suite in order to provide a standardized, scalable and compliant platform for the cell and gene therapy market.
With immunotherapies playing an ever-increasingly important role in clinical oncology development, Werum IT Solutions and the Blood Centers of America have teamed up to develop a “vein-to-vein” digital supply chain solution suite in order to provide a standardized, scalable and compliant platform for the cell and gene therapy market.
The partnership was announced this week at the fifth-annual CAR-TCR Summit in Boston. Under terms of the agreement between BCA and Germany-based Werum IT Solutions, which currently supplies MES solutions to a number of players in the CAR-TCR fields, including Novartis and Kite the two partners will jointly develop a seamless digital supply chain solution suite for cell and gene therapy. It will integrate manufacturing and supply chain logistics as well as the collection of autologous/allogenic cell-based raw material in the manufacture of cell and gene therapies. The cell and gene market will benefit from standardized processes, scalability of their products, full control of the chain of compliance and electronic batch recording.
Werum’s PAS-X MES program will play an important role through its capabilities to track and control patient’s material. As the companies note, during the clinical phase, there are thousands of data points between patient, donor, raw material and material management. Werum’s PAS-X provides one GMP compliant electronic batch record allowing real-time data access and analysis, increasing data quality and reducing per batch execution effort and risk of human error.
Charles Mooney, vice president of Bio-Development and Quality Management at the Oklahoma Blood Institute and BCA Cell Therapy Committee Chair, told BioSpace in an exclusive interview that the partnership will create an important milestone in the cell and gene business. Mooney said it’s of “paramount importance” for BCA to be able to maintain consistency within the collection protocol of clinical trials. He said it will bolster the efficiency of drug manufacturers as they move forward with their clinical programs. By providing the drug companies with a totally paperless system, Mooney said they will drive the consistency that companies are looking for in their good manufacturing needs.
Dr. Andreas Fischer, Senior Head of the SafeCell business unit at Werum, said the partnership will allow them to share knowledge and resources in order to “develop an end-to-end supply chain management solution of cell and gene therapies integrating manufacturing and logistics for the complex process of delivering such therapies to the patient.”
Calling the type of partnership with BCA and Weruma “first,” Mooney said the program includes everything necessary for companies in the gene and cell industry, “from the time the patient is identified as a candidate to the time the patient receives the drug would be paperless.” Mooney said the “endgame” of the partnership will be consistent data collection formats at each of the 52 BCA facilities.
“Once the protocol is developed for a manufacturer, they will then know that every facility will be collecting all the data and that data will be formatted the right way automatically,” Mooney said.
Mooney noted that within the industry, there has been a desire for standardization and that was something BCA and Werum wanted to provide.
“This is within our space and we decided it was time to drive that standardization,” he said.
Mooney added that the system will also allow drug manufacturers to audit the data from the sites in “real-time” from their offices, rather than having to send individuals to each site separately. In the long-run, he said that will save manufacturers time and money in their programs. It will also save any “re-work” time for data collection, he noted.
While the partnership was announced at the CAR-TCR Summit, Mooney said the program is not yet ready to be implemented. Werum hopes to have a first version of the program online in 2020.
