WHY WAISMAN Facility

Waisman currently operates and maintains seven cGMP compliant cleanroom areas to accommodate clinical production of mammalian and microbial therapies and aseptic filling of final products.  The facility was designed to maximize regulatory compliance and environmental quality and as such provides specific zones or defined areas for each type of activity with appropriate attributes to support and segregate different manufacturing processes. The entire clinical manufacturing facility is key-access controlled and is isolated from other operations within the Waisman Center.

In July 1999, the Waisman Center presented its design and process flows to the U.S. FDA's Center for Biologics Evaluation and Research (CBER). Based on this review the facility's design meets/exceeds FDA guidelines for clinical research purposes.  Design and construction for Waisman Biomanufacturing began in 1999 and was completed in 2001, with our first project initiated in 2001.  To accommodate a growing need for cell processing space, in 2009 our facility was expanded to include an additional three-room suite for mammalian cell processing.  This modular cleanroom expansion has been in use on a full-time basis for a variety of cell therapy projects.

Facility Special Features:

  • Direct digital control of room pressures, air flow, temperature, and humidity by MetaSys (Johnson Controls, Inc.) with separate Air Handling Units (AHUs) for manufacturing areas
  • Equipment Monitoring System (Rees Scientific) monitors critical parameters and alarms for all cGMP equipment
  • Keycard access control to facility: cleanroom manufacturing areas, cell bank storage, and raw material quarantine/release rooms
  • Multiple pass-through compartments for flexible production of cell therapeutics or complex biologics
  • Dedicated showers and gowning areas for entering Microbial and Mammalian/Cell Therapies Suites
  • Pure steam generator for steam-in-place (SIP) bioreactors
  • Dedicated cGMP sterilization and decontamination autoclaves with steam supply from pure steam generator
  • Separate and locked “Quarantined” and “Released” raw materials and manufactured product storage areas
  • Dedicated cell bank and viral bank gas phase liquid nitrogen storage freezers
  • Separate ready supply and decontamination areas

 

 

Facility Maintenance/Equipment  Validation:

  • Greater than 364 cleanroom cleanings
  • Semi-annual and annual biological safety cabinet and HEPA certifications
  • More than 500 equipment calibrations/verifications
  • Quarterly and annual equipment monitoring certifications and testing
  • Monthly testing of Rees Equipment Monitoring System
  • IQ, OQ, and PQ validation protocols for equipment and validation master plans
  • SOPs detailing cleaning and validation protocols
  • Dedicated cleaning staff trained in executing SOPs (training record documentation)