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Applications

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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application1.jpg

PLGA
small mol.
200 micron

Embolization

application2.jpg

PLGA
[no API]
15&40 micron

Intravitreal

application3.jpg

PCL
small mol.
15&40 micron

Intravitreal

application4.jpg

PLGA
peptide
15&40 micron

Subcutaneous

application5.jpg

Prop. Polymer
small mol.
15&40 micron

Medical device

application6.jpg

Prop. Polymer
small mol.
15&40 micron

Injectable

application7.jpg

Hybrid
polymer
15&40 micron

Injectable

application8.jpg

PLGA
biomolecules
15&40 micron

Immunology

application9.jpg

PLGA
small mol.
15&40 micron

Medical device

application10.jpg

Solid fat
prop. protein
15&40 micron

Topical

application11.jpg

PLGA
small mol.
15&40 micron

Injectable

application12.jpg

PLGA
small mol.
15&40 micron

Injectable

Scale Up

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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Pilot-plant-prototype.jpg

GMP

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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