Repligen intends to establish a new biopharmaceutical facility. New facility with supporting utilities is planned to be established at a site to be selected. The new facility will be a good manufacturing practice (GMP) suite with capabilities to manufacture and harvest a product from a multistage e-coli microbial culture process. The premises will be equipped with a two-stage fermentation process, harvesting and purification equipment and associated clean and black utilities systems for production at the 500 L working volume microbial biosynthesis scale.
Production facility is planned to be applied for manufacturing and analysis of biopharmaceuticals products for manufacturing studies.
A new suite of clean rooms and the equipment required for manufacturing of culture derived product are as per below:
– Microbial Biosynthesis Area: Manufacturing of recombinant proteins in microorganisms. Clean rooms for media/feed solutions preparation, inoculation, fermentation, cell product separation, cell disruption and initial recovery activities and the associated personnel and material transfer airlocks.
– Purification Area: Purification of recombinant proteins from microorganisms and cell cultures. Clean rooms for buffer preparation, protein purification and bulk fill.
– Supporting Areas: Other support rooms are required for personnel gowning, material airlocks, corridors, etc.
Thompson Consultants, Inc. was hired to review possible sites and provide an assessment of what would be required to support the proposed suite. TCI was also involved in the programming and space planning to ensure proper work synthesis between process and flow of materials. The construction estimate was developed to include the cost of the process equipment based upon industry estimates and manufacturer quotations.