Without tests and assays, any product purporting to be GcMAF can be without activity and useless.
GcMAF needs to be produced in highly professional sterile laboratories by GMP-trained scientists. Sterile, certified substrates with traceability should be used, with sterile, certified equipment.
Tests can include:
1. Sterility – to USP and Ph Eur sterility standards preferably performed externally.
2. Endotoxin test to confirm the absence of endotoxins in the sample. It should be 0.02 to 0.03, the bottom limit of detection. (10.0 is the max acceptable)
3. Protein Quantification using BCA Protein assay
4. Electrophoresis Silver Stained SDS Page for product identification;
5. Electrophoresis Western blot probed with biotin labelled Helix Pomatia Lectin (binding directly to the terminal N-acetylgalactosaminyl present in Gc MAF).
6. Electrophoresis Western Blot probed with Anti Vitamin D Binding Protein (specific to Gc Globulin and Gc MAF)
7. RAW 264.7 live macrophage cell based proliferation assay for activity, ie potency,
8. Breast carcinoma phagocytosis activity assay. Macrophages are added to live MCF7 breast cancer cells; nothing happens. GcMAF is added; withIn 72 hours the macrophages are observed to phagocytise (eat and destroy) the cancer cells.
9. Third activity assay: GcMAF is added to MCF7 cancer cells without macrophages. On addition of GcMAF a cell morphology change is observed In 72 hours where cancer cells adopt a normal cell morphology. (Experiment first performed by Professor Ruggiero’s team and published January 2012)
The molecules of GcMAF prepared should be identical to those made by the human body.
Activity assays are vital – GcMAF must be proven to exist, be sterile, and most importantly, be active, and activity assays can only be done with living cells.
Contamination: A good laboratory should aim for a viral clearance of better than 10 to the power of 20.