Discover how QbD Group supported a global biotech company in commissioning and qualifying two ATMP therapy production sites, ensuring compliance and efficiency.
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.
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.
QbD Group provided expertise and structured execution to ensure the success of the project. The approach included:
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.
继续阅读
成功案例Discover how QbD Group helped a pharmaceutical facility in Barcelona optimize and validate a complex autoclave load, improving sterilization efficiency and manufacturing flexibility.
阅读更多
成功案例Discover how QbD Group helped a global pharmaceutical company address fluctuating validation demands across multiple teams.
阅读更多
成功案例QbD Group has facilitated the launch of a new drug production line for treating hemophilia, overseeing the qualification of over 100 pieces of small-scale supporting equipment.
阅读更多