Laboratory standardsCyto Innovations Ltd works in accordance with ISO17025 and GMP European regulations, raw materials are registered and notified to the relevant authorities from where they are purchased. |
Lectin activity assayBiotinylated Vicia Villosa Lectin Assay. Samples are separated in 12% SDS PAGE and analyzed in WB using lectin specific for terminal GalNAc. Batch should be declared a “PASS” if native blots are observed. |
Cell based activity assayProliferation assay using RAW264.7 cells. When applied at a level of 40ng/mL to cells during a 72h incubation causes a retardation in cell proliferation when compared to cells that have had no additive or MAF added at the same concentration. The batch should be considered a “PASS” if the cell proliferation is <80% of the D-VDBP treated cells.
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Sterility testingSamples of each batch are sent for external sterility testing at a third party testing house. The test is a sterile filtration test which was validated for the procedure to meet the Ph. EU and USP In addition sample material is also incubated in TSB and Thioglycollate Broth between 20-35ºC for 14 days. The batch should be declared a “PASS” if there is complete absence of any bacterial growth in any of the broths or filter test. |
Endotoxin detectionSamples of each batch are tested for the presence of endotoxin using a Charles River Endosafe PTS FDA approved endotoxin detection device. The batch should be declared a “PASS” if there is <0.25 EU/mL. With a 0.25mL dose this is <0.0625EU/dose below the permissible limit of 5EU/Kg body weight. |
PH level assessmentPH.Samples of each batch are assessed for pH with limits set between pH7.0-7.9. The batch should be declared a “PASS” if the measured pH is between pH7.0 and pH7.9. |