We regenerate
We regenerate proven conventional practices of the pharmaceutical industry and we ingeniously adapt them to the ATMP market. Take a look at our innovative use of new materials to develop customized isolators.
The needs and challenges of manufacturers can be very diverse. Start-ups, for instance, have to quickly develop, at lower cost, and figure out how to evolve over time. On the other hand, companies with more mature products need to reinvent themselves to control costs, stay ahead of the competition and upgrade to fit the regulatory requirements.
Unfortunately, the available solutions aren’t always as unique as the difficulties. This is where salamanderU comes in. We are above all a project partner that meets all the specifications of the manufacturer’s needs. Notwithstanding the high quality we deliver, salamanderU is available for every project and provides custom made solutions at affordable prices.
Our multidisciplinary team of experts in engineering, business knowledge and technological knowhow allows us to adapt – like a salamander – to all kinds of situations. Therefore, we always offer innovative and smart responses to our client’s challenges.
We regenerateWe regenerate proven conventional practices of the pharmaceutical industry and we ingeniously adapt them to the ATMP market. Take a look at our innovative use of new materials to develop customized isolators.
We provide innovative technical solutions to unsolved problems. By adding voice recognition capabilities to electronic Batch Records we drastically simplify eBR operations.
We systematically challenge current practices and propose creative options to improve manufacturing processes. Our remote-controlled data units and smart units are just some of the examples of our creativity.
Each of these three values leads to our ultimate goal: to reduce the cost of your pharmaceutical operations. We help you to decrease your Operational Expenses and the number of FTEs needed – ask for our proof points.
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 and construction of a synthetic resin isolatorDesign, 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 of a voice-controlled Electronic Batch RecordDevelopment 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 of an application for remote supervisionDevelopment 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?
Installing, testing and validatingInstallation, testing and validation of the three previous elements at the subcontractors’ sites.
MaintenanceMaintenance of the installations.