Merck, Biologics Drug Substance Facility, USA

A modular facility initiative by Merck for monoclonal antibodies began with a modularisation study prepared by KeyPlants. Our development work included layouts for seven specified processes in a design to be deployed globally.

Merck’s production process is based on human IgG obtained by recombinant DNA technology.  We based our solution for the fill-finish facility on our Modular Aseptic Solutions (MAS) design platform. The facility design for Merck’s three different bulk processes (Therapeutic Proteins TP, Microbial Vaccines MV, and Live virus Vaccine LVV) were based on our Modular Bio Solutions (MBS) design platform.

We then modified both our MBS and MAS design platforms based on our analysis of Merck’s requirements and process data. The conceptual design development of KeyPlants’ MBS platform for Therapeutic Protein, Bacterial and Live Viral Vaccines (BSL 3) extends from upstream to downstream processing.