In our state-of-the-art cGMP facility, DisperSol is able to produce KinetiSol® amorphous powder intermediate for the supply of non-GLP studies, GLP toxicology studies, and Phase I/II clinical studies. Our validated equipment includes an instrumented tablet press and tablet coater for production of clinical trial material, which we can package into labeled induction sealed bottles.
Work is ongoing to establish high-volume cGMP KinetiSol® manufacturing lines for product supply of Phase III studies and commercial sale. DisperSol is also able to work with partners to establish KinetiSol® manufacturing lines for high volume production in their own or third party facilities.
Drug Product Manufacturing:
- Amorphous powder for constitution
- Amorphous powder for processing into final dosage form
- Finished coated or uncoated tablets
- For GLP and non-GLP studies
- For Phase I/II clinical studies