Merck to use prefabricated adjustable cleanrooms at $300m FLEx center
Merck broke ground on its $300m (€268.17m) formulation laboratory, experimental (FLEx) center in Rahway, New Jersey alongside its partner, G-CON manufacturing. The pharmaceutical company selected G-CON manufacturing to provide prefabricated and flexible cleanroom solutions for the center earlier this year.
The FLEx Laboratory will focus on expediating the process between product development and manufacturing for clinical trials. G-CON’s POD technology will be used in the FLEx center, providing the site with prefabricated and installed modular and podular clean room configurations for flexible manufacturing and formulation.
Allen C. Templeton, VP of pharmaceutical sciences at Merck Research Laboratories, said in a statement that the groundbreaking of this facility will commence the company’s first steps into establishing reconfigurable technology for its evolving pipeline.
“We are creating a range of smaller, more agile facilities to address the increasing demands of treating diverse patient populations. A combination of modular and podular configurations within our new FLEx center will enable this flexibility,” said Templeton.
The pods themselves can be moved inside or outside the facility and can be reconfigured for different needs that may arise during formulation and development, for both sterile and oral solid-dosage products made at the facility.
According to Merck, the modular and podular spaces will serve as a testing center for clinical products and will provide an apparatus in which inefficient equipment can be replaced without need for renovation. Through this, the processes can be streamlined for small-scale manufacturing.
Merck’s New Jersey site, fitted with the cleanroom pods, is scheduled to be open in 2021 and will employ around 130 people.
In recent years, G-CON has collaborated with companies like Pall Corporation, GE Healthcare, and even repurposed its PODs into containment spaces during the Ebola virus outbreak in West Africa during 2014.
Its collaboration with GE Healthcare in January of this year, saw G-CON produce its PODs in combination with the healthcare company’s supply of cell therapy and viral vector technologies to create a manufacturing platform for companies working in cell therapy.
The partnership is designed for small biotech companies to build their own manufacturing facilities to replace or supplement supply from contract manufacturing organizations, amidst demand in the cell and gene therapy space.
Previous to its collaboration with GE Healthcare, G-CON and Pall worked together to create prefabricated cleanroom PODs that could be customized with Pall’s bioprocessing equipment for manufacturing.