Guiding a global biotech company through ATMP facility qualification

Qualification & Validation

Pharma, ATMP

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Bringing an ATMP production facility to operational status requires meticulous planning, regulatory compliance, and technical expertise. When a global biotechnology company set out to commission and qualify two new ATMP therapy production sites, they faced tight deadlines, complex validation processes, and a transition from paper-based to digital documentation.

QbD Group stepped in to provide strategic project planning, risk-based qualification, and quality-driven process improvements, ensuring the facilities met all necessary GMP standards and were fully prepared for clinical validation runs.

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1

Challenge

2

Approach

3

Result

Challenge

Navigating complex ATMP facility commissioning

The project involved the commissioning and qualification of two advanced therapy medicinal product (ATMP) production sites. With overlapping timelines, the client needed to transition from paper-based to digital documentation.

Additionally, the limited experience with the cryogenic phase of production posed a significant challenge. A critical aspect was the qualification of 500 small-scale process and lab equipment within a tight timeframe to support process validation runs.

Discover our approach

Approach

Strategic execution for compliance and efficiency

QbD Group provided expertise and structured execution to ensure the success of the project. The approach included:

• Overall project planning, follow-up, and issue management
• Risk-based qualification approach, ensuring regulatory compliance
• Quality-driven continuous improvement, including updated GMP-compliant templates
• Support for requalification and improvement activities after equipment release

Read more about the results

Result

Achieving timely qualification and certification

Through QbD Group’s structured approach, all equipment was qualified and released on time, allowing the project to proceed smoothly. Additionally, the sites were successfully certified for clinical validation runs, ensuring compliance with industry standards and enabling the client to move forward with production.

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Facing the complexities of ATMP facility commissioning and qualification?

Our experts can support you with strategic project planning, risk-based qualification, and quality-driven process improvements, ensuring your facilities meet GMP standards and are ready for clinical validation. Contact us today to discover how we can support your ATMP production site projects.

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