Cytoinnovations 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 assay
Biotinylated 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 assay
Proliferation 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.
Samples 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.
Samples 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 assessment
PH.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.