Our Goleic is made in highly professional sterile laboratories by GMP trained scientists. We use sterile, certified substrates with traceability, and sterile, certified equipment.
Every batch is subjected to internal and external assays.
They have the following production assays:
1. Sterility – to USP and Ph Eur sterility standards performed independently and externally. We have a perfect sterility record.
2. Endotoxin test to confirm the absence of endotoxins in the sample. Its 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 Goleic).
6. Electrophoresis Western Blot
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. We add our Goleic; withIn 72 hours the macrophages are observed to phagocytise (eat and destroy) the cancer cells.
9. Third activity assay: we add our Goleic to MCF7 cancer cells without macrophages. On addition of Goleic 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 (with our Goleic) and published January 2012)
We have carried out about 100 assays on our Goleic.
Activity assays are vital – Goleic must be proven to exist, be sterile, and most importantly, be active, and activity assays can only be done with living cells.
Chances of contamination: We calculate our viral clearance as one in 10 to the power of 31, ie one in 10000000000000000000000000000000.
Our Goleic is one of the safest treatments available, safer than most GMP products.
If you have any questions about assays, email or call us by clicking on “Contact” at the top