Sanofi Aventis Pilot Plant

Sanofi Aventis - Bridgewater, NJ

Chemical Development Pilot Plant
Aventis Logo

This $50M USD Advanced Pharmaceutical Intermediate (API) pilot plant consisted of a process wing and associated ancillary support facilities for cGMP operation, which provided each reactor system, isolation device, and dryer in individual suites. The design provided for Level 3 containment per International Society for Pharmaceutical Engineering (ISPE) Baseline.

 


Aventis retained Process Facilities Inc. and its affiliates (PFI) to develop a design and associated cost estimate for a new state-of-the-art Chemical Development Pilot Plant at the Bridgewater, New Jersey campus.

This $50M USD Advanced Pharmaceutical Intermediate (API) pilot plant consisted of a process wing and associated ancillary support facilities for cGMP operation, which provided each reactor system, isolation device, and dryer in individual suites. The design provided for Level 3 containment per International Society for Pharmaceutical Engineering (ISPE) Baseline.

PFI’s design met the requirements for multi-purpose cGMP operation by providing each reactor system, isolation device, and dryer in individual suites therefore providing Level 3 containment per International Society for Pharmaceutical Engineering (ISPE) Baseline. The design provided an expansion of Building Q with a process wing and associated ancillary support facilities, which will combine a precast concrete and glass facade to aesthetically fit in the Bridgewater campus yet be functional from an operational, and maintenance perspective. The design also incorporated the proper environmental control systems necessary to meet the site’s effluent / emissions criteria.

The new facility fullfilled the following needs:

  • Scale-up of laboratory processes developed by chemical or process development.
  • Supply drug candidates for pre-clinical, phase 1 and phase 2 programs.
  • Application and testing of process technologies for future commercialization.
  • Development of process data and documentation for technology transfer of processes to commercial scale within Aventis and/or contract manufacturers.
  • Be versatile for multi-purpose operation yet meet strict cGMP requirements for clinical development and supply.
  • Meet stringent effluent / emission requirements.
  • Have an exterior appearance which fits within the existing Bridgewater campus.
  • Mechanical completion within 1 year.

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