Mobile production units

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A lab in a truck: operate at your patient’s bedside

Cell and gene therapy products used in clinical phase trials often have a short shelf life, or their active duration is unknown. This means the drugs must reach the patient quickly, to be administered within a few hours of their final formulation. Our cGMP mobile unit makes this possible, as it allows you to perform your aseptic operations at your patient’s bedside, so to speak.

There’s the truck

The mobile formulation unit developed by salamanderU comes in the form of a truck which has a changing room, operation room and technical area. The truck’s operation room has everything needed to formulate the drug right next to the hospital. So you can deliver the drug to the patient right after finalizing it.

Why you might need this mobile system


Easy transportation 

Thanks to the unit’s mobility, you can run clinical phase trials at several hospital sites, even if they are located far apart. The team working in the truck is always connected to its company through the GPS system and mobile communication.


Environmental control of the mobile unit

Inside the truck, the formulation activities take place in a regulated environment. This working area is kept at 15-25 °C by an air flow system hosted in the technical area at the back of the truck. This rear area has a grade D environment.


Storage space

The mobile unit has plenty of space to safely transport personnel and all necessary equipment and raw materials. It also includes a storage space to keep materials cool at different temperatures, varying from 2 °C to 8 °C or even -25 °C. We use a mobile cryogenic shipper for these cold temperatures.


Approved 

A risk analysis of the mobile unit – in transit, on arrival at its destination and during its use as a formulation unit – shows that it fully meets cGMP requirements. The unit has also been approved by the public health authorities of Belgium, France and Italy.

Custom-built for your operations

salamanderU can custom-make a mobile unit fit for each step of your aseptic operations. Here’s an example of a mobile unit we designed for one of our customers who develops cell therapy products.

One of their products had to be administered to the patient in a medical setting within 6 hours after its final formulation. By transplanting the aseptic and temperature-controlled formulation process performed at our customer’s single plant to a mobile unit brought near the clinical site, the products could be delivered within their shelf-life.

A closed formulation system, in which the product does not come into contact with the environment, was designed and validated to aseptically prepare the final product in a non-aseptic environment. A temperature-controlled production room was designed and fitted on a truck frame. It was used to both transport the required equipment to the clinical site and to formulate the products at the site.

This innovation has enabled the delivery of the cell therapy products to remote patients who could not have been treated within 6 hours of completing the formulation at our client’s premises. The formulation process and equipment have been inspected and approved by the Belgian Health Authorities (FAMHP).

The closed system’s ability to maintain aseptic conditions in a Grade D back area has been fully demonstrated and, as part of the validation process, specification-compliant batches of the product have been successfully formulated in the mobile unit in the UK. Several patients were then treated with products formulated in the mobile unit in Belgium and in France.