Confidential Biotechnology Client
Vaccine Manufacturing
Massachusetts
Paulus, Sokolowski and Sartor (PS&S) provided regulatory, architectural* and engineering services for a 22,000 sf biotech facility for Clinical Manufacturing and launch of a therapeutic vaccine product.
PS&S developed a Site Master Plan starting with an initial review of the Clinical Manufacturing requirements that included a comparison of manufacturing in-house versus contracting that function to a third party.
The facility was constructed for prodcution of bulk vaccine bulk and sterile filling in the final container in 2 ml vials. The general manufacturing environment was maintained as Class 10,000 active (Grade B) grade with once-through Class 100 (Grade A) air over the process zone using biosafety cabinets. The process utilities included WFI (Water-for-Injection) and clean-steam systems.
PS&S prepared the Validation Master Plan and generated Installation Qualification/Operational Qualification (IQ/OQ) protocols. PS&S also worked with the owner's quality assurance group in planning the fast-track validation of the clinical manufacturing facility.
*Architectural services are provided by Paulus, Sokolowski and Sartor Engineering, P.C., Paulus, Sokolowski and Sartor Architecture, P.C., PS&S California, Inc., or Paulus, Sokolowski & Sartor Architecture and Engineering Connecticut, P.C.