Biologics Modular is leasing its mobile production facilities to help clients make FDA regulated drugs without fixed plants.
In partnership with MEI Healthcare Capital Biologics Modular will lease its mobile, modular facilities and cleanrooms. Biologics Modular thinks the model will appeal to research park innovator biopharm that need access to flexible and affordable GMP (good manufacturing practice) production capacity.
“The current business model for drug manufacturing companies is changing, and as we see more offsite research and development, there is a growing need for affordable quality facilities”, Clark Byrum, Jr, president and CEO of Biologics Modular, said.
Biologics Modular is pitching the model as an alternative to outsourcing to contract manufacturing organisations (CMOs). Instead of outsourcing manufacture of clinical trial materials biopharm can have a Biologics Modular facility temporarily installed at their site to handle production.
The facilities are manufactured by Biologics Modular at its site in Indiana before being qualified and validated. Clients also receive support with process validation, GMP quality control and regulatory strategies.
By taking this modular, pre-constructed, pre-tested approach to facility design Biologics Modular claims it can deliver a plant within 20 weeks. Validation and commissioning is said to take days.
Building a facility
The facilities are housed in steel shipping containers. Inside the containers Biologics Modular installs pre-constructed, pre-tested modules, like giant Lego pieces, to equip the production facility.
Once constructed the facility is relocated to, for example, a leased light industrial warehouse. When the plant is no longer needed it can be decommissioned and, in most cases, Biologics Modular will handle the removal.