Advanced Granulation Technology(8)
Homogeneity of Physical Characteristics
Table 1 reports pH, osmolality and moisture content data derived from samples of the 9kg, 90kg and 500kg batches. The entire pH range of reconstituted media was 7.31-7.46, a range of ± 0.075 pH units, or ±1.0%. This variation was well within the tolerance of cells and for media manufacture. (The target pH can be set at any desired range such that, upon reconstitution, no pH adjustment is required). The osmolality range was from 325-330 ± 2.5 mOsm units, or ±0.8%. This exceptionally tight distribution suggests a highly ordered and consistent process. (Note: Osmolality can also be set to any desired value). Final moisture content ranged 2.00-2.76%. Even though liquid spraying was involved in AGT™ granulation, simultaneous process evaporation reduced moisture content to that of conventional DPM (typically 2-3%).
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