The approach described below shows how we helped one of our clients facing the following significant challenge:

Subcontract the production of autologous pluripotent stem cells of muscle origin (MdMSC) with the certainty that the production process will be strictly followed for each batch of cells manufactured by each subcontractor.

Design, construction and validation of a synthetic resin isolator adapted to the dimensions of the Grade D room in which it will be installed. The isolator was designed to be able to integrate all the equipment necessary for cell manufacturing, such as a microscope and incubators, and to comply with all the regulatory requirements imposed on operations to be carried out in Grade A. Examples include cleaning and disinfection with H2O2, counting viable and non-viable particles, etc.

Do you want simplicity in the design of your aseptic areas and reduce your operational expenses by 30%?

Development and validation of a voice-driven electronic batch record that vocally guides operators during batch production. It also records information provided by operators and automatically generates a batch record that complies with regulatory requirements at the end of production.

Do you want to streamline your documentation processes?

Development and validation of an application that allows remote (cloud) and real-time monitoring of operations carried out, whether these are carried out simultaneously or not by one or more subcontractors.

Do you want to subcontract your MTI (ATMP) manufacturing?

Installation, testing and validation of the three previous elements in the subcontractors' premises.

Maintenance of facilities.