LIFE SCIENCES
Behind the successful transfer of a first biological product
One of our clients required support for the transfer of its first biological products to a production site in Belgium. The objective was to ensure coordinated execution of validation and manufacturing activities, while preparing the site for commercial production in compliance with GMP requirements. ALTEN was engaged to provide coordination and operational support across departments involved in the technology transfer and industrialisation process.
The challenge
The project involved coordinating activities related to a new production unit dedicated to biological products, requiring strong alignment between multiple departments.
Key challenges included:
- Conducting an initial assessment of the site and processes to identify gaps, readiness requirements, and potential risks associated with the technology transfer
- Maintaining a global overview of validation activities for cleanrooms, equipment, systems, and processes linked to the transfer
- Coordinating the manufacturing of pre-validation batches and first commercial batches
- Supporting teams in their preparation activities prior to launch
- Ensuring effective tracking of deviations, CAPA, change controls, and work orders to meet deadlines
- Maintaining traceability of validation activities, production records, and compliance with GMP standards throughout the transfer process
These activities required continuous coordination to ensure progress and readiness across all functions.
The solution
ALTEN provided project management and coordination support to ensure the proper execution of technology transfer activities. The scope included:
- Performing an initial audit and gap assessment to identify readiness levels, compliance requirements, and key risks impacting the transfer
- Coordination of validation activities across all relevant systems
- Support to process validation and manufacturing during pre-validation and commercial batches
- Preparation and review of validation documentation
- Follow-up with departments to ensure readiness before commercial launch
- Tracking of deviations, CAPA, change controls, and work orders to maintain timeline adherence
- Managing risks through continuous monitoring, mitigation actions, and cross-functional escalation when required
- Ensuring full traceability of validation activities, compliance with GMP standards, and production documentation throughout the project lifecycle
The project was executed using GMP standards, local procedures, and standard office tools, supported by strong collaboration between stakeholders. planning reliability, improve responsiveness to demand variability, and maintain continuity across a complex global supply chain network.
Results & benefits
ALTEN’s involvement ensured structured coordination of validation and manufacturing activities throughout the technology transfer process. This contributed to:
- Alignment of cross-functional teams involved in the project
- Controlled follow-up of quality and compliance topics
- Execution of activities in line with project timelines for production readiness
Key project takeaways
This project underlines the importance of strong coordination and planning in technology transfer programs, particularly when multiple departments are involved in validation and manufacturing activities. Through an initial gap assessment, proactive risk management, robust traceability of validation and production documentation, and expertise in quality and compliance processes, ALTEN contributed to ensuring alignment, maintaining control of critical activities, and supporting readiness for commercial production while meeting GMP standards.
