MyCellHub.com provides a data management platform specifically designed for GMP-compliant manufacturing of cell-based products, streamlining data collection, review, and approval workflows. The software eliminates fragmented paperwork and manual processes, ensuring accurate data entry and timely compliance with regulatory standards.
Funding
$4.5M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
GMP-compliant manufacturing of cell-based products relies on manual data collection and paper-based processes, leading to fragmented workflows, increased risk of errors, and challenges in maintaining data integrity. These manual operations are time-consuming, error-prone, and make it difficult to ensure timely compliance with regulatory standards.
Solution
MyCellHub provides a data management platform designed to streamline GMP-compliant manufacturing for cell and gene therapies, CDMOs, and GMP facility services. The platform replaces fragmented paperwork with a centralized, digital system for data collection, review, approval workflows, reporting, and analytics. MyCellHub ensures accurate data entry through features like barcode scanning and built-in data integrity checks, while interactive work instructions and automated calculations help teams follow correct procedures and reduce the risk of errors. The system is designed to facilitate compliance with 21 CFR Part 11 and EU Annex 11.
Target Audience
MyCellHub targets GMP facilities, cell and gene therapy manufacturers, and contract development and manufacturing organizations (CDMOs) involved in advanced therapy production.
Features
- Electronic Batch Records: Tracks any production process, replacing paper-based records with digital documentation.
- Cleanroom Cleaning Management: Manages tasks and schedules to maintain cleanroom cleanliness.
- Environmental Monitoring: Organizes sample plans and automates trending analysis for environmental data.
- Sample Tracking: Provides real-time visibility into the location and status of samples throughout the testing process.
- Cleanroom Testing Management: Manages cleanroom testing workflows and data.
- Inventory Management: Tracks stock levels and expiration dates of materials.
- Training Management: Maintains records of workforce training and development.
- Equipment Management: Schedules and tracks equipment maintenance activities.
- Device Integration: Connects hardware and software systems for automated data capture.