The startup offers a healthcare manufacturing data management platform that utilizes blockchain technology to ensure secure, immutable, and trackable data for autologous medicine production. By digitizing scheduling and quality approval processes, the platform enhances manufacturing efficiency, making these therapies more deliverable and affordable for patients.
Funding
$3.1M 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.
IUFounders
Product
Problem
Advanced therapy medicinal product (ATMP) manufacturers face challenges in managing complex data workflows, scheduling, and quality control processes, often relying on paper-based systems that are prone to errors and lack traceability. This can lead to inefficiencies, increased costs, and difficulties in scaling operations to meet growing demand.
Solution
Autolomous offers AutoloMATE, a software platform designed to streamline manufacturing data management for ATMP manufacturers, facilitating the scaling of advanced therapy production. The platform digitizes batch manufacturing records (eBMRs), automates calculations, and integrates data from various systems like LIMS and QMS, reducing manual errors and accelerating processes. AutoloMATE CLOCK digitizes manufacturing scheduling, optimizing facility operations by accounting for clinician schedules, equipment availability, and courier interactions. AutoloMATE Assist supports batch verification by assessing data against Critical Quality Attributes, enabling quality stakeholders to perform reviews based on "review by exception" methodologies. The platform employs ledger technology to ensure data immutability and compliance with regulatory guidelines such as UK MHRA, EU EMA, and US FDA.
Target Audience
The primary target audience includes advanced therapy medicinal product (ATMP) manufacturers, contract development and manufacturing organizations (CDMOs), and quality assurance/quality control (QA/QC) personnel involved in cell and gene therapy production.
Features
- Digitized batch manufacturing records (eBMR) that can be configured for autologous (CAR-T, TIL, DC vaccine) and allogeneic (NK, IPSC, MSC) workflows
- Automated scheduling of manufacturing operations with AutoloMATE CLOCK, considering clinician schedules, equipment, and cleanroom availability
- Batch verification support with AutoloMATE Assist, enabling review by exception methodologies
- Integration with Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), cell counters, and flow cytometers
- eBMR Builder for configuring and editing eBMRs on the platform
- Reporting module for identifying trends, bottlenecks, and learnings to optimize manufacturing
- System audit functionality for tracking changes, login attempts, and product record access
- User group segregation for CDMOs to keep manufacturer data separate
- Role-based access control and e-signatures for enhanced security and compliance
- Data encryption at rest and in transit, with enforced TLS 1.3 for web browsers
- Two-factor authentication (2FA) via email
- Compliant with ISO 9001, ISO 27001, and ISO 14001 standards