Process development and scale up
After the pre-clinical phase, the formulation can reproducible be scaled to clinical and market relevant volumes. Depending on the application a Pilot Plant or the Manufacturing Plant are most suitable.
The Pilot Plant is designed to produced material for typical clinical phase 1 and phase 2 batches, up to 5 kgs dry weight of microparticles. The Manufacturing Plant is designed for clinical phase 3 batches and market relevant volumes, designed for full scale continuous production of up to 10 metric tons per year.
Both systems are based on EmulTech's “process intensification and numbering out” scale up strategy. This approach assures process conditions similar to the INFINITY MINI and the INFINITY LAB. As a result the particle characteristics are identical.
GMP manufacturing services
All systems are suited for cGMP manufacturing. Proper validation and certification is done with experienced CMOs that host EmulTech systems to supply cGMP batches with the proper regulatory requirements (EMEA/FDA). If you are interested in the contract manufacturing of your product, feel free to contact us.