Challenge

In 2012 Promethera Biosciences search a solution to deliver in shorten time Advanced Therapy Medicinal Products (ATMPs).

To meet this request, the sterile formulation process has been transposed into a mobile formulation unit operating near the medical site so as to deliver the product within its short shelf-life.

Closed formulation system

A closed formulation system, in which the product never comes into contact with the environment, is used to aseptically formulate the ATMPs in a non-aseptic environment.

Mobile Facility

A truck was fitted with a standard production room in order to both bring the equipment at the clinical site and to provide a suitable formulation facility.

The rear technical area hosts an air flow system that keeps the room at 15-25°C and maintains a class D environmental cleanliness.

There is enough storage space to securely transport all the raw materials and the equipment.

The mobile production unit is used to both transport the material and to manufacture the product. Once on site, it is ready within one hour.


Outcome

The closed manufacturing process and the mobile formulation unit have been approved by different European authorities.

ATMPs anywhere in Europe within its limited shelf-life. It provides excellent flexibility and control of quality at reduced cost.

ADC-Group is proud to announce that this project is nominated for Industrie Awards 2013 in the Best Process category.

ADC-Group is active in the life sciences, agro food, industry and environmental sectors where we propose engineering and contracting services with alternative and result oriented solution to our customers.