Sanofi, Biologics Facility Upgrade & Remediation Projects

About this project

DPS undertook a large upgrade project to ensure security of supply of cGMP compliant orphan drug biologics. Onsite equipment includes two cell culture and harvest suites (4x5000L and 2x5000L bioreactors) and two purification suites.

Project scope

Purification remediation project

For the purification remediation project (known as DSP), DPS provided detail design and construction administration services. DPS completed risk analysis and gap analysis and identified design deliverables to remediate the purification suites and all supporting equipment including but not limited to chromatography skids, holding tanks, and transfer methods.

Cell culture remediation project

The cell culture remediation project was of similar scope and included cell culture suite 1 (CC1): a suite that consists of 4x5000L bioreactor trains with media preparation, media hold, and harvest equipment which DPS conducted qualification on. Sanofi also built a new RENA media prep area with new SS mixing vessels (8K liter) and piping to the media hold tanks, on which DPS performed the qualification and cleaning validation on.

Facility upgrades included:

MEP – piping systems, electrical, and HVAC modifications.
General I&C upgrades including migration to DeltaV.

Achievements:

DPS was able to successfully perform all remediation activities while the plant was fully operational, which presented many segregation and isolation challenges. DPS was fully involved in designing around and facilitating the construction activities while ensuring the least interference with ongoing operations. The shutdown and overall project successfully completed on schedule and on budget while mitigating interference with current manufacturing.