Rapid QC Lab Qualification for Gene Therapy Company

A newly-acquired gene therapy company needed to quickly release a therapy for a rare disease, requiring the qualification of a QC lab within a tight 8-month timeframe.

Challenge:

The primary challenge was time: 22 instruments needed to be qualified and ready for use within 6 months. Leveraging vendor qualification was only part of the solution; coordinating site visits and planning internal qualification work around the vendors posed a significant challenge. Additionally, ensuring a smooth data flow plan for the entire lab was essential.

Approach:

To tackle the challenges, we deployed on-site consultants with expertise in gene therapy lab instruments, data storage, and data mapping. They were familiar with the specific challenges related to data integrity and could efficiently navigate the qualification process. We worked out a release plan by grouping the most challenging and similar instruments together.

Implementation:

Our team worked closely with the client, other consultants, and vendors to schedule site visits, coordinate qualification efforts, and establish a robust data flow plan. We monitored progress and addressed any obstacles that arose during the qualification process.

Outcomes:

The project was completed within the set timelines and budget, enabling the client to qualify their QC lab and have it ready for production use.

Lessons Learned:

Effective collaboration, strategic planning, and leveraging specialized expertise can significantly accelerate the qualification process for a QC lab, ensuring timely completion and compliance with regulatory requirements.