IIR document
An original freeze-drying cycle design for a temperature sensitive molecule.
Author(s) : LHOSPICE F.
Summary
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 200 mg). 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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Details
- Original title: An original freeze-drying cycle design for a temperature sensitive molecule.
- Record ID : 2008-2756
- Languages: English
- Source: New Ventures in Freeze-Drying
- Publication date: 2007/07
Links
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Indexing
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Lyophilisation ou cryodessiccation.
- Author(s) : REY L.
- Date : 2008/11
- Languages : French
- Source: Revue générale du Froid & du Conditionnement d'air - n. 1088
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Einfluss des Einfriervorganges auf die Porenstr...
- Author(s) : DKV, SCHOOF H., BRUNS L., APEL J., HESCHEL I., RAU G.
- Date : 1997/11/19
- Languages : German
- Source: DKV-Tagungsbericht 24. 1997, Hamburg.
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Trends in der Gefriertrocknung.
- Author(s) : OETJEN G. W.
- Date : 2002/01
- Languages : German
- Source: KI Luft Kältetech. - vol. 38 - n. 1
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Quality by design in freeze-drying process deve...
- Author(s) : WANG D. Q.
- Date : 2007/07
- Languages : English
- Source: New Ventures in Freeze-Drying
- Formats : PDF
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FREEZE-DRYING PROCESS OF TRIDIMENSIONAL OBJECTS.
- Author(s) : REUTTER K.
- Date : 1982
- Languages : German
- Source: Acta Histochem. - vol. 25
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