DNA vaccines - Page 6

[Th1Th2]

Originally Posted by gr8blessings

Yes, HBsAg (short form for HBV surface antigen) is produced using recombinant DNA technology, however the resulting HBsAg does not contain any DNA as HBsAg is a protein. DNA to RNA to protein. This is the central dogma of molecular biology. The surface antigen PROTEIN is purified BEFORE the PROTEIN is injected into the subject. Nothing is made in vivo, except antibodies in response to the PROTEIN. The HepB vaccine does not contain any detectable amount of DNA or transcriptional units, if you like that term better.

Like what I have said, any protein contains a DNA blueprint. And the HBV antigen, HbsAg, indeed has DNA.

DNA removal from a purification process of recombinant hepatitis B surface antigen

Abstract

We studied the capacity of an API-rHBsAg purification process to eliminate DNA contamination from yeast-host cell. Firstly, was demonstrated consistency of manufacturing purification process to remove DNA, from (3.9 ± 1.9)108 pg/dose in starting material to (3.4 ± 1.6) pg/dose, equivalent to 8.2 log in Active Pharmaceutical Ingredient (API), measuring DNA quantity in several unit operations.........
Overall, these studies indicate that total DNA clearance factor for API-rHBsAg manufacturing process was 19.4 log, 2.4 times higher than the real DNA contamination, indicating that API-rHBsAg manufacturing as described here have sufficient DNA reducing capacity to achieved a high margin of DNA safety.

So DNA purification is actually the process of reducing DNA contamination at a safety margin based on a certain calculation. But unfortunately, the website is not showing the table/graph:

For further comparison, DNA quantities were expressed in picogram per adult dose of 20 µg rHBsAg according to:

where DNA and rHBsAg represents it respective quantity.

The DNA log10 reduction factor (RF) was calculated individually for each operation according to:

where DNAinitial is the starting DNA quantity in pg/dose and DNAfinal is output DNA quantity after performing purification operation. The total DNA reduction factor was calculated as a sum of the individual log reduction factor.

Any trace or residual amount of DNA in the vaccine after purification is still significant in the cellular uptake of HbsAg that can lead to mutagenesis.

Carcinogenesis, Mutagenesis, Impairment of Fertility
RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential
to impair fertility.

Recombinant DNA Hepatitis B vaccine is definitely a DNA vaccine.

[Th1Th2]

Like what I have been saying all the time, vaccines are not placebos. They contain the physiologic evidence of the disease-causing microorganisms. Recombinant DNA vaccines like Hepatitis B and Gardasil still retain their viral DNA markers in the vaccines. Purification process is simply a reduction of contamination at a safe and acceptable level.

DNA removal from a purification process of recombinant hepatitis B surface antigen

DNA considered as cellular contaminant rather than risk factor which required removal to extremely low level and in biopharmaceutical productions, the principal source is host cell DNA..... In this regard, regulatory authorities state that level of DNA from the host cell can be detected by direct analysis on the product considering that levels of 10-100 pg of residual DNA of host cell origin per dose of a parenterally administered biopharmaceutical is considered to be an acceptably safe level by most of the medicinal agencies (FDA, 1985; Griffiths, 1997; Trouvin, 1997). Nevertheless, in general guidelines for recombinant proteins, there is no precise specification of what an acceptable or tolerable level of contaminating DNA might be, but recommendations are given in some specific monographies as for recombinant hepatitis B vaccine

[anewmama]

Originally Posted by emma1325

Did you know that most vaccines are manufactured in China?

Not saying it's not true, but I tried to find this out once and was never able to find out anything except something that said that they are not made there and only with possibly will the market open up to manufacturing there. Not saying they don't make them, but do you have a source for this? WHat about India? They seem to make alot of our pharmaceuticals.

[emma1325]

Originally Posted by anewmama

Not saying it's not true, but I tried to find this out once and was never able to find out anything except something that said that they are not made there and only with possibly will the market open up to manufacturing there. Not saying they don't make them, but do you have a source for this? WHat about India? They seem to make alot of our pharmaceuticals.

I got that from Dr. Russell Blaylock. I'll try to find another source.

[anewmama]

That would be great because I did a long google search once and could not find anything about this being the case.