English to Russian Medical Medical: Pharmaceuticals

Purity III – SDS-PAGE
Taliglucerase alfa single protein band shows similar pattern to reference
5 ± 3 °C for 4 months; 4 days at 25 °C;
5 ± 3 °C for remainder of study
Purity III – automated electrophoresis(revised method)
Glycosylation isoform peak:
--*
Purity IV – SE-HPLC
NR
Total dimer + aggregates:
< 4%
250 - 320 mOsm/kg
Cellular uptake inhibition
Cellular uptake
56-140% relative potency
Complies**
NA = not applicable; NP = not performed; NR = not reported
* Taliglucerase alfa produced using earlier Drug Substance manufacturing processes *produced a glycoform distribution* that is not resolved using the automated electrophoresis method, therefore the specifications for this material using this method are not applicable.
**Complies refers to no growth observed
*** Specifications are those in place at the time of testing
Results of Photostability Testing of Control Sample and Unpackaged Vials (Batch No:
PR2007)
Protalix DS Lots:
DS010210TC PACKAGE TYPE:
Result Control sample