Commercial production under cGMP
Aseptic cGMP production
- Robust protocol development
- Inert fluidic path suitable for CIP (clean in place)
- Validated cleaning procedure
- Automatic batch record generation and operations logging (In compliance with FDA: 21 CFR Part 11)
- Maintenance management
- Live process visualization
Closed system production capabilities
Good manufacturing practice
Sterile manufacturing is a requirement for many pharmaceutical products. To enable clinical production of microspheres with microfluidics Emultech has created a technology platform suitable for aseptic manufacturing.
Fill & finish
Emultech is partnering with a range of CDMOs incorporating our cGMP system to provide fill & finish capabilities for clinical production of your parenteral and other drug products.
Emultech is the first and only company in the world to create a technology platform on the basis of microfluidics that can produce from a single chip several kilograms of microspheres on a weekly basis. Further parallelization can increase the throughput to meet your specific requirements.