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EDITORIAL
GRAPHENEand DERIVATES : PHYSICO- CHEMICAL and TOXICOLOGY properties in
the m- Rna VACCINE MANIFACTURING STRATEGY
Needed specific proof of absence for the regulatory aspects
AUTHORS
1)Luisetto M IMA academy Marijnskaya , professorship toxicology , pharmacology
natural science branch italy
2) Tarro G ,President of the T & L de Beaumont Bonelli Foundation for Cancer
Research, Naples Italy
3) Edbey K, Professor, Departmentof Chemistry, Libya PhysicalChemistry,
University of Benghazi, Libya
Keywords : Graphene, covid -19 , m RNA, vaccine, side effects ,
toxicology,chemistry manifacturing tecnhnology and materials, contaminations,
impurity
Corresponding author :luisetto M maurolu65@gmail.com +393402479620 italy PC
29121
Abstract
Observing thefact that every year various registerd and authorized drugs are
recalled by the public regulatory agency ( in example last Ranitidin cases due by the
possibility of impurity presence of a cancerogenic sustantia ) it is interesting to
observethe innovative production strategy of somem RNA vaccine .
Also for the bio- technological drugs product the regulatory agency ask quality
stantard for impurity for the obiously safety implications.
The biotechnological drugs , as the classic chemical drugs , due by the complex
manifacturing process useraw material and industrialprocedurethat require
Great quality monitoring according the GMP normativerules.
So it is no to strange to discuss of impurities in this new kind of products
And also for the covid-19 vaccine.
Introduction
This work startby recent and really interesting new evicence ( DISINFECTIONad
Natura Docet Darkfield microscopeanalysis n 1/ 2022 ) and other research works
published also by university professors and other professionals . ( CAMPRA P
univerisy of ALMEIRA , YOUNG R O , YOUNG Mi LEE et al , GIOVANNINI F et al) .
Before of all it was done a review of interesting article related the chemico- physical
and toxicological property of graphene derivates ( also woks published before the
Covid-19 Pandemia) as well as distribution profile related the way of
subministration.
Itwas also analyzed ADR charactheristics that somerecent Covid-19 vaccinehave
reported in the pharmacovigilance center ( national and international ) .
Great attention was done towards the verify of the manifacturing technology used
in field od
m RNA vaccine since formthe research in oncology.
Fromliterature Grapheneand Grafene Oxide GO and other derivates are subjectof
many use in bio- technological research : in diagnostic field but also in production
and expecially in last decades.
Itis possibleto report Carrier or adiuvant or extractive property ( there are study
that show increase in immune responceafter their use) , and objectof research for
INTRA NASAL covid-19 vaccine.
Properties to improve RNA extraction- purification in manifacturing field.
( absrobtion property, increase RNA stability )
In someliterature are described use of pegylated nanolipids whit graphene oxide
In m RNA Vaccineresearch development. ( some producers can providethis raw
material and the technical and security sheet are easy available on internet ) .
On literature as well as by bio-technological producers there are variuos products
made of MAGNETIC MICROBEAS used for extraction of RNA derivates.
This are all use Knowed at today and easily verifible in biomedical database since
not suspicious times .
Interesting also to note as there is also a PREPRINT written by the CEO of a great
pharmaceutical industry that produces innovative covid-19 vaccineand other
researcher of the same indutry reportamong the reagent for production of a covid-
vaccine per non human primates magnetic micro beads . ( see reference on article
under publication as reported ).
(And on literature are reported article works about grapheneGO - magnetic
microbeads.).
Materials andmethods
With an observationalpoin of view some relevant literature is analyzed in order to
producea global conclusion related the topics of this work .
Results
Fromliterature :
Results
Are reported reference ( 1-46)
Discussion
So related to all of this , matching the evidence of sometest on vials of vaccine as
well as reseacth on dark filed miscrosocpy and related the fact that the toxicological
profile of this particles seem to correlate with the ADRreported ( rare thrombosys
, pericarditis and other ).
Also the chemico-phyicalproperties of this particles are so peculiar and make
possibleto give explanation of somephenomena.
According the authors it is clear that it is needed to deeply investigate this evidence
verifying the manifacturing technological process in order to clear if are presence
or not possible pollutants residues of production even if this are not declared and
reported on official techincal sheet and registered by public health authorities.
(In the raw materials , reagents of final product).
The pharmaceutical producers useoften to buy raw materials form other producers
The same author submitto the researcher to analyzea more wider and significative
number of vials of the various vaccinefor covid-19 , trought various and certified
independet laboratory and using the blind technique.
To confirm this proposalthere are the evidence collected in some university as in
some research study reported ( TURIN UNIVERSITY- CHEMISTRYfaculty ,
CAMPRA P. - UNIVERSITYOF ALMERIA professor CHEMICAL SCIENCE).
Regarding the contaminants it is of interest to report thay in 26 August2021 BBC
news Coronavirus pandemic Japan suspends 1.6 million Moderna doses over
contamination fears A staff of Japan"s supermarketgroup Aeon receives a doseof
the Moderna vaccine“Japan has suspended the use of about 1.63 million doses of
the Moderna vaccine due to contamination.
A metallic substantia the react with magnete finded in some lots .
Of interest finally to remember two recent italian judgesententia : PISA EFIRENZE
2022 it was recognized in one cause- effect relationship between a covid-19
vaccination and a Thromobocitopenia reaction in an 16 years old ,and in the other
case the judge written that this vaccine are experimental , Dna invasive, potentially
of irreversibleeffect and not prevedile at today .
Even if this drugs areofficially registered by regulatory agency during the last years
In example somecountries restricted uses of some covid-19 vaccinein determinate
subpopulation even initially not done .
The same some technical sheet was recomded to be updated by EMA PRAC
introducing some Rare ADR not presentin the first approved VACCINE oneor also
changed the name of the vaccinein order To update registrativedocuments
reporting new controindications.
Conclusion
As global concusion it is possibleto ask to the innovative vaccine producers to
provideofficial written proof of chemico-analytical absence of graphene and
derivates in the final vaccine product.( the same by the international regulatory
agency ).
The same to providefull clarification of the bio-technological manifacturing process
Even if there are patent of industrialsecret
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Kathrin U. Jansen , Ugur Sahin
Affiliations:
BioNTech, An der Goldgrube12, 55131 Mainz, Germany;
Pfizer, 401 N. Middletown Rd., Pearl River, NY 10965, United States;
Pfizer, 280 ShennecossettRd., Groton, CT 06340, United States;
SouthwestNational Primate Research Center, Texas Biomedical Research Institute,
8715 W.
Military Dr, San Antonio, TX 78227, United States;
University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555,
United States;
Texas Biomedical Research Institute, 8715 W Military Dr, San Antonio, TX 78227,
United States;
TRON gGmbH – TranslationalOncology at the University Medical Center of the
Johannes
Gutenberg University, Freiligrathstraße12, 55131 Mainz, Germany;
Correspondence: Prof. Dr. Ugur Sahin, BioNTech SE, An der Goldgrube12, 55131
Mainz, Tel: +49 6131 2161 201; Email: Ugur.Sahin@biontech.de
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DNA and RNA extractions from eukaryotic and prokaryotic cells by graphene
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Magnetic particles for the separation and purification of nucleic acids
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Separation and Purification Technology
RNase-freeRNA removaland DNA purification by functionalized magnetic particles
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45) ORIGINAL RESEARCH article
Front. Bioeng. Biotechnol., 25 May 2020
Sec. Nanobiotechnology
https://doi.org/10.3389/fbioe.2020.00421
Biointerfacing 2D Nanomaterials and Engineered Heterostructures
GrapheneOxide Nano-Concentrators Selectively Modulate RNA Trapping According
to Metal Cations in Solution
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Marco De Spirito, Wanda Lattanzi and Massimiliano Papi
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Markopoulou, C.K.;Karagianni, A.; Kachrimanis, K.
mRNA Therapeutic Modalities Design, Formulation and Manufacturing under
Pharma 4.0
Principles. Biomedicines 2022, 10, 50.
https://doi.org/10.3390/biomedicines10010050

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EDITORIAL GRAPHENE and DERIVATES CHEMICO-PHYSICAL AND TOXICOLOGICAL PROPERTIES IN m RNA vaccine MANIFACTURING STRATEGY - STATE OF EVIDENCE

  • 1. EDITORIAL GRAPHENEand DERIVATES : PHYSICO- CHEMICAL and TOXICOLOGY properties in the m- Rna VACCINE MANIFACTURING STRATEGY Needed specific proof of absence for the regulatory aspects AUTHORS 1)Luisetto M IMA academy Marijnskaya , professorship toxicology , pharmacology natural science branch italy 2) Tarro G ,President of the T & L de Beaumont Bonelli Foundation for Cancer Research, Naples Italy 3) Edbey K, Professor, Departmentof Chemistry, Libya PhysicalChemistry, University of Benghazi, Libya Keywords : Graphene, covid -19 , m RNA, vaccine, side effects , toxicology,chemistry manifacturing tecnhnology and materials, contaminations, impurity Corresponding author :luisetto M maurolu65@gmail.com +393402479620 italy PC 29121 Abstract Observing thefact that every year various registerd and authorized drugs are recalled by the public regulatory agency ( in example last Ranitidin cases due by the possibility of impurity presence of a cancerogenic sustantia ) it is interesting to observethe innovative production strategy of somem RNA vaccine .
  • 2. Also for the bio- technological drugs product the regulatory agency ask quality stantard for impurity for the obiously safety implications. The biotechnological drugs , as the classic chemical drugs , due by the complex manifacturing process useraw material and industrialprocedurethat require Great quality monitoring according the GMP normativerules. So it is no to strange to discuss of impurities in this new kind of products And also for the covid-19 vaccine. Introduction This work startby recent and really interesting new evicence ( DISINFECTIONad Natura Docet Darkfield microscopeanalysis n 1/ 2022 ) and other research works published also by university professors and other professionals . ( CAMPRA P univerisy of ALMEIRA , YOUNG R O , YOUNG Mi LEE et al , GIOVANNINI F et al) . Before of all it was done a review of interesting article related the chemico- physical and toxicological property of graphene derivates ( also woks published before the Covid-19 Pandemia) as well as distribution profile related the way of subministration. Itwas also analyzed ADR charactheristics that somerecent Covid-19 vaccinehave reported in the pharmacovigilance center ( national and international ) . Great attention was done towards the verify of the manifacturing technology used in field od m RNA vaccine since formthe research in oncology. Fromliterature Grapheneand Grafene Oxide GO and other derivates are subjectof many use in bio- technological research : in diagnostic field but also in production and expecially in last decades. Itis possibleto report Carrier or adiuvant or extractive property ( there are study that show increase in immune responceafter their use) , and objectof research for INTRA NASAL covid-19 vaccine.
  • 3. Properties to improve RNA extraction- purification in manifacturing field. ( absrobtion property, increase RNA stability ) In someliterature are described use of pegylated nanolipids whit graphene oxide In m RNA Vaccineresearch development. ( some producers can providethis raw material and the technical and security sheet are easy available on internet ) . On literature as well as by bio-technological producers there are variuos products made of MAGNETIC MICROBEAS used for extraction of RNA derivates. This are all use Knowed at today and easily verifible in biomedical database since not suspicious times . Interesting also to note as there is also a PREPRINT written by the CEO of a great pharmaceutical industry that produces innovative covid-19 vaccineand other researcher of the same indutry reportamong the reagent for production of a covid- vaccine per non human primates magnetic micro beads . ( see reference on article under publication as reported ). (And on literature are reported article works about grapheneGO - magnetic microbeads.). Materials andmethods With an observationalpoin of view some relevant literature is analyzed in order to producea global conclusion related the topics of this work . Results Fromliterature : Results Are reported reference ( 1-46)
  • 4. Discussion So related to all of this , matching the evidence of sometest on vials of vaccine as well as reseacth on dark filed miscrosocpy and related the fact that the toxicological profile of this particles seem to correlate with the ADRreported ( rare thrombosys , pericarditis and other ). Also the chemico-phyicalproperties of this particles are so peculiar and make possibleto give explanation of somephenomena. According the authors it is clear that it is needed to deeply investigate this evidence verifying the manifacturing technological process in order to clear if are presence or not possible pollutants residues of production even if this are not declared and reported on official techincal sheet and registered by public health authorities. (In the raw materials , reagents of final product). The pharmaceutical producers useoften to buy raw materials form other producers The same author submitto the researcher to analyzea more wider and significative number of vials of the various vaccinefor covid-19 , trought various and certified independet laboratory and using the blind technique. To confirm this proposalthere are the evidence collected in some university as in some research study reported ( TURIN UNIVERSITY- CHEMISTRYfaculty , CAMPRA P. - UNIVERSITYOF ALMERIA professor CHEMICAL SCIENCE). Regarding the contaminants it is of interest to report thay in 26 August2021 BBC news Coronavirus pandemic Japan suspends 1.6 million Moderna doses over contamination fears A staff of Japan"s supermarketgroup Aeon receives a doseof the Moderna vaccine“Japan has suspended the use of about 1.63 million doses of the Moderna vaccine due to contamination. A metallic substantia the react with magnete finded in some lots .
  • 5. Of interest finally to remember two recent italian judgesententia : PISA EFIRENZE 2022 it was recognized in one cause- effect relationship between a covid-19 vaccination and a Thromobocitopenia reaction in an 16 years old ,and in the other case the judge written that this vaccine are experimental , Dna invasive, potentially of irreversibleeffect and not prevedile at today . Even if this drugs areofficially registered by regulatory agency during the last years In example somecountries restricted uses of some covid-19 vaccinein determinate subpopulation even initially not done . The same some technical sheet was recomded to be updated by EMA PRAC introducing some Rare ADR not presentin the first approved VACCINE oneor also changed the name of the vaccinein order To update registrativedocuments reporting new controindications. Conclusion As global concusion it is possibleto ask to the innovative vaccine producers to provideofficial written proof of chemico-analytical absence of graphene and derivates in the final vaccine product.( the same by the international regulatory agency ). The same to providefull clarification of the bio-technological manifacturing process Even if there are patent of industrialsecret
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