Marken opens new GMP-compliant facility in Philadelphia
The new depot – connected to the existing logistics hub and near the Philadelphia airport – is fully validated and compliant with the US Food and Drug Administration’s (FDA) Good Manufacturing Practice (GMP) regulations.
The facility accommodates various storage temperatures, including +15 to +25°C controlled ambient storage, +2 to +8°C refrigerated storage, -15 to -25° C frozen storage, and -80° C ultra-low freezers.
It also will offer receipt, pick and pack, hybrid shipping, returns handling and destruction, re-labeling and inventory reconciliation services.
Additionally, Marken is planning to add an area for storing genetically modified organisms (GMO) and will feature liquid nitrogen filling equipment and ultra-low temperature shipping containers.
As part of the expansion, the 24/7 Patient Communications Center and project management services in Philadelphia also will be expanded. According to the company, the development will help accommodate “the increased number of complex protocols being handled from this location and the increased demand for direct to patient shipments.”
In April of this year, Marken introduced a container for shipments of clinical drug products, clinical drug substance, as well as cell and gene therapies. The custom-designed thermal box is described as “the first truly configurable container capable of utilizing any GPS tracking device available today.”
Marken’s Smart Box offers constant visibility of the cargo, providing information about location, temperature, movement, shock, pressure, and light. The container uses the company’s Sentry tracking device, while also accommodating Bluetooth technology for temperature monitoring and identification.
