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
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
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.
What Our Clients Say
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