IPH1101/BrHPP is a New Chemical Entity and acts as an agonist of T Lymphocytes VG9D2. IPH1101 is currently tested in phase II clinical trials in some cancer indications. IPH1101 is a water soluble drug substance, highly hygroscopic. The drug substance is unstable in aqueous solution, and is sensitive to moisture content and temperature. Therefore IPH1101 has been formulated as a freeze-dried product (IPH1101 200mg). The first freeze-drying cycle design had been developed for phase I clinical studies, with a "classical" temperature slope for each step. Unfortunately, this freeze-drying cycle didn't supply robust results; i.e. a part of IPH1101 drug product batch (up to 30%) must be removed due to a non conventional aspect. Therefore a most advanced knowledge on IPH1101 low temperature behaviour has been needed and a new approach to design freeze-drying cycle has been setup to supply clinical trials with pharmaceutically acceptable drug product.
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