Digital batch records, data management platform, analytics platform

MyCellHub specializes in providing advanced software solutions tailored for the manufacturing of cell and gene therapies, particularly within the context of Contract Development and Manufacturing Organizations (CDMOs). Their platform is designed to enhance Good Manufacturing Practice (GMP) compliance by integrating various operational processes, such as electronic batch records, environmental monitoring, and inventory management. This comprehensive system aims to streamline workflows, reduce the risk of errors, and ensure that all team members adhere to the correct procedures, thereby facilitating 'right-first-time' manufacturing. The software also features modules for cleanroom cleaning, sample tracking, and equipment management, which collectively contribute to maintaining high standards in biomanufacturing environments.

In addition to improving operational efficiency, MyCellHub's technology emphasizes the importance of data integrity and accessibility. By digitizing documentation and automating processes, the platform eliminates the need for cumbersome paperwork, allowing for real-time data entry and faster approvals. This digital transformation not only enhances traceability and compliance with regulatory standards, such as 21 CFR part 11 and EU Vol 4 annex 11, but also supports training management and device integration. Overall, MyCellHub's solutions are designed to optimize the production of advanced therapies, making it easier for organizations to manage their operations effectively while ensuring compliance and quality control.

Belgium

MyCellHub.com - Digital GMP workflows

MyCellHub provides a toolkit for the digitalisation, data integration and data analytics of regulated laboratory and cleanroom workflows. More than 90% of biotech and (bio)pharmaceutical companies currently create production reports on paper. It's time to accelerate the launch of new therapies and not be held back anymore by paperwork.

MyCellHub

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