Aeras Global Vaccine TB Foundation
Recombinant BCG Vaccine Launch Facility
Rockville, Maryland
Paulus, Sokolowski and Sartor (PS&S) was retained by the Aeras Global TB Vaccine Foundation to design and validate a 16,000 sf current Good Manufacturing Practice (cGMP) vaccine manufacturing facility that includes a Process Development Lab, Clean and Plant Utilities, Laboratory suites and office space.
The manufacturing facility was fitted out on the third floor of a commercial building. The associated utility and heating, ventilating, and air conditioning (HVAC) equipment was located either on the same floor or on the building's roof.
The main unit operations are: inoculums preparation; bacterial fermentation; centrifugation and bulk filling of the vaccine into plastic bags. The process is classified as BL3-LS (Biosafety Level 3 -Large Scale). The fermentation and centrifugation equipment require containment and a validated bio-inactivation prodeure must be executed prior to the opening of any vessel or process line containing live cells.
A Clean-in-Place (CIP) sytem is provided for fixed process equipment while a portable equipment and components are cleaned and sterilized in autocalaves and a parts washer. All Bio-Waste from the BL3 facility is thermally decontaminated in a Bio-Kill System before being discharged to the municipal waste system.
*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.