EmulTech's unique control over particle size provides many advantages. First and foremost is the high reproducibility both between batches as during scale up.
Second is the absence of process related uncertainty that hinders effective development. With fixed process conditions, one can easily make the right decisions for obtaining the desired formulation.
The third advantage is the capability of making novel formulations with innovative product characteristics. Examples are single shot multiple release formulations, or combination therapies.
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PLGA Embolization |
PLGA Intravitreal |
PCL Intravitreal |
PLGA Subcutaneous |
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Prop. Polymer Medical device |
Prop. Polymer Injectable |
Hybrid Injectable |
PLGA Immunology |
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PLGA Medical device |
Solid fat Topical |
PLGA Injectable |
PLGA Injectable |
After the pre-clinical phase, the formulation can reproducible be scaled to clinical and market relevant volumes. Depending on the application the Pilot Plant or the Manufacturing Plant is 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.
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The INFINITY platform is GMP ready for customers to produce their samples under (sterile) cGMP conditions.
The equipment is easily made aseptic for sterile production without the need for end-sterilization. All the wetted components in these closed setups can be autoclaved. 0.22 micron filters ensure sterile liquids. The capabilities for sterile production have already be confirmed in dozens of sterile productions for pre-clinical in vivo samples. Also EmulTech ran a process simulation trial with a cGMP certified CMO to prove the suitability of operating the equipment in a cGMP environment.
Together with its trusted partners (ISO 13485 certified and/or FDA inspected) and a few selected customers, EmulTech works on the cGMP validation of the INFINITY platform.
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