Manufacturing Execution System (MES) software for CGCT pre-GMP Advanced Therapies Digital & Automation Productivity Testbed

Concepts

• computer aided manufacturing (CAM)
• stevenage
• software development
• cgct pre-gmp advanced therapies digital
• mes
• automation productivity
• cell therapies
• digital & automation productivity testbed
• testbed
• a manufacturing execution system

Location

Stevenage

Description

Provision of a Manufacturing Execution System (MES) tailored explicitly for the field of cell therapies, The MES platform should enable resource scheduling, inventory optimisation, management & execution of electronic batch records and overall manufacturing workflows, review and release activities. All workflows should be client-configurable and controlled, through the use of a zero-code, platform-embedded, builder configuration tool. The platform should be designed to comply with US FDA, EU EMA & UK MHRA guidance and aligns with the GAMP5 validation methodology, as well as being CFR 21 Part 11 compliant.

Award Detail

Award Criteria

CPV Codes

• 72212323 - Computer-aided manufacturing (CAM) software development services

Indicators

• Award on basis of price.

Legal Justification

The provision of services involved are purely for the purpose of research, experimentation, study or development, Autolomous have developed a Manufacturing Execution System tailored explicitly for the field of cell therapies. Unlike other MES solutions repurposed from different sectors, Autolomous? offering is designed from the ground up to meet the unique challenges and complexities inherent in cell therapy manufacturing processes. Autolomous? aim is to democratise access to life-altering treatments, making them universally available, economically viable, and logistically feasible. Central to this software suite is the autoloMATE platform. The MES platform enables resource scheduling, inventory optimisation, management & execution of electronic batch records and overall manufacturing workflows, review and release activities. All workflows are client-configurable and controlled, through the use of a zero-code, platform-embedded, builder configuration tool. The autoloMATE platform has been designed to comply with US FDA, EU EMA & UK MHRA guidance and aligns with the GAMP5 validation methodology, as well as being CFR 21 Part 11 compliant.