GcMAF1Protein concentration of unprocessed VDTP preparation has been determined by Bradford assay (IB-16.05.00). After processing, VDTP final solutions were prepared in concentrations: 167 ng/ml; 1,000 ng/mI and 3,334 ng/mI (±10%) in relation to initial concentration.

1. Formulation and characteristics 

Formulation and characteristic parameters have been confirmed organoleptically.

2. Protein concentration

Protein concentration of unprocessed VDTP preparation has been determined by Bradford assay (IB-16.05.00).

After processing, VDTP final solutions were prepared in concentrations:

167 ng/ml; 1,000 ng/mI and 3,334 ng/mI (±10%) in relation to initial concentration.

3. Protein identity has been confirmed by mass spectrometry

ProteinPurityMassSpec 3

Accuracy of measurement is ±1%, therefore result of 50,969 Da is acceptable for VDTP (51,243 Da ).

4. Purity

Protein purity has been evaluated with densitometry.

The amounts of 0.5, 1 and 2 ktg of VDTP protein were loaded on SDS-PAGE gel. After electrophoretic separation, gel was stained with Coomassie Brilliant Blue. Absorbance intensity analysis was performed using Image Lab 5.2.1 software.

ProteinPurity 2

5. Endotoxin level

Endotoxin level in VDTP has been evaluated using Limulus Amebocyte Lysate (LAL) assay. 

6. Sterility

Total aerobic microbial count has been evaluated by inoculating Trypone Soya Agar with 100 [..t1 of VDTP and incubation at 37°C for 5 days. No colonies were observed.

Total combined yeast and mold count has been evaluated by inoculating Sabouraud (+ dextrose + chloramfenikol) with 100 µl of VDTP and incubation at 37°C for 5 days. No colonies were observed.

Both tests were done in triplicates.

Absence of E.coli in 10g has been confirmed by inoculating McConkey Broth with 10g of VDTP and incubation at 37°C for 5 days. No turbidity was observed.

Reference: USP29-NF24 page 3087 http://www.pharmacopeia.cn/v29240/usp29nf24s0_c2023.html#usp29n124s0_c2023 [18th November 2016]

7. Mycoplasma

Mycoplasma presence in VDTP has been evaluated by NAT (Nucleic Acids Amplification Techniques). Result was negative. 

8. Retrovirus

Retrovirus presence in VDTP has been evaluated by PERT (Product Enhanced Reverse Transcriptase assay). Result was negative. 

9. pH

pH of the VDTP solution has been determined using Hanna Instruments HI2212 pH-meter. Measurement was repeated three (3) times and average value was calculated:

ProteinPurityPH

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