Cell & Gene Therapy Manufacturing Facility
A cell and gene therapy manufacturing facility, qualified in time to supply patients in clinical trials.
- Owner
- Confidential
- Region
- U.S. Mid-Atlantic & Northeast
- Market
- Life Sciences
- Capital value
- $450M
- Size
- 210,000 SF
- Delivery
- EPCM
- Duration
- 30 months
- Completed
- 2025
What was at stake.
Clinical trial timelines depended on the facility producing its first engineering batch on time. Cleanrooms, single-use equipment and quality systems all had to be qualified before any product could be made. The EPCM schedule showed construction finishing but left qualification as one line.
How we controlled it.
What our schedulers and cost engineers did on this project.
Qualification in the baseline
Commissioning, IQ, OQ and PQ for each suite were scheduled as real work tied to the first engineering batch.
Cleanroom certification
Each suite was tracked through certification and environmental monitoring, with float to its first batch.
Earned value
A cost-loaded schedule gave leadership SPI and CPI by suite every month.
Risk to supply
Monte Carlo analysis on the first batch showed P50 and P80 dates the clinical team could plan around.
The result.
In cell therapy the building is half the job. Qualification decides the finish, so qualification is in the baseline.
Lead scheduler, AdenTurton
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