The difficulties that come with ATMP operations can be very diverse. So tackling them requires a tailor-made approach. Our aim is to help you overcome your difficulties by offering you the most innovative solutions possible, while closely adapting them to your individual needs.
Our experience in the ATMP industry means we can help you optimize the costs of your manufacturing processes and accelerate the implementation of your regulatory compliance process. We achieve this by adapting and validating solutions used in the traditional pharmaceutical industry to the specifics of ATMPs, with our own creative touch to give you high added value.
The approach outlined below is an example of how we helped one of our customers to tackle a major challenge: how to outsource the manufacturing process of patented autologous pluripotent muscle-derived stem cells, while ensuring that every step in the process is followed precisely for each lot of the drug product manufactured by the subcontractors.
Design, construction and validation of a synthetic resin isolator adapted to the dimensions of the D-grade room where it was to be installed. This isolator is designed to integrate all the equipment needed to manufacture cells, such as a microscope and incubators, and to meet all the regulatory requirements for operations carried out in A-grade rooms. Examples include H2O2 cleaning and disinfection, and viable and non-viable particle counts. Do you want simplicity in the design of your aseptic areas and reduce your OPEX by 30%?
Development and validation of a voice-controlled Electronic Batch Record, which ‘speaks’ to guide the operators during the production of a batch. It also records the information given orally by the operators and automatically generates a batch record at the end of each operation in accordance with regulatory requirements. Do you want to streamline your documentation processes?
Development and validation of an application for remotely following the operations via the cloud in real time, even if they are performed simultaneously and by multiple subcontractors.Do you want to subcontract your ATMP manufacturing?
Installation, testing and validation of the three previous elements at the subcontractors’ sites.
Maintenance of the installations.