Production of the Pfizer BioNTech mRNA jabs
Billions of Jabs, Trillions of Dollars projected. Let us look at what we know about the manufacturing of the Toxic Spike Protein coding packaged in the Toxic LNPs
It seems that Fifth Column operatives want to hide some of the facts about the massive taxpayer expenditure on the failed Covid19 jabs.
Here I will concentrate on Pfizer BioNTech that has achieved market dominance.
The production processes for materials used in the Phase 1 trial were not the same as those used in the Phase 2/3 trials, and most likely contributed to variations reported in Serious Adverse Events for various Lots or Batches.
The European Medicines Agency made a Major Objection to Pfizer/BioNTech changing the process to use toxic E. coli instead of RT-PCR for the commercial product. Pfizer replied "as the cutoff date for the clinical Interim Analysis (IA) was changed, the IA doesn’t include data from subjects dosed with Process 2 material, and the Company does not expect to have Process 2 included in the Final Analysis dataset"
This document will be key in numerous Court cases around the world.
My article is confined to key steps in the manufacture of the Pfizer Biontech jabs, not contractual, packaging, serialization, transport, storage or regulation issues, many of which are covered in 50 Chapters of the Book produced by the DailyClout teams.1
Pfizer acquired Subsidiary Companies for Jabs
In order to prepare for potentially Trillions of Dollars profit from mass jabbing, Pfizer invested heavily in its manufacturing plants in the US, including a $200 Million expansion in Andover, seen here.
It also acquired patent rights and other companies along the way.2
Briefly they were:
Warner-Lambert for $116 billion in June 2000.
Pharmacia for $60 billion in 2003
Wyeth for $68 billion in 2009
Hospira for $16 billion in 2015
Medivation for $14.3 billion in 2016
Array BioPharma for $11.2 billion in 2019
After Pfizer started manufacting Covid19 jabs they purchased Trillium Therapeutics for $2.2 billion.
Manufacturing Process 1 compared to Process 2
Robert Kogon has been investigating the operations of BioNTech and has concluded their published timeline for developing is false and in fact they began development before the first cases of Covid19 were announced by WHO.3
He also describes how BioNTech got its mRNA wrapped in LNPs.
“To get the mRNA wrapped in the Acuitas lipids, the mRNA had to be shipped to an Austrian subcontractor by the name of Polymun outside Vienna.”
The very first jabbees were paid recruits in Germany used to compare 4 different jabs and different doses. The first 6 subjects for each variety were taken into Hospital for close observation and monitoring.
Note that these batches contained less RNA, more Residual DNA Template contamination, lower effective 5’-Cap, higher levels of Poly(A) Tail, than others.
Looking at the “high-level summary of process changes” we see that Magnetic Bead Purification used in Process 1 was replaced by Ultrafiltration/Diafiltration (UFDF) to improve removal of undesirable materials in Process 2. (Table S.2.6-2 Process Comparison). A reader has kindly informed me the Magnetic Beads were made by ThermoFischer Scientific.4
An interesting patent uses the word Endotoxin 117 times, discusses the expensive Magnetic Bead Purification method of deadly poison removal.5 Pfizer used This technology for Process 1 jabs, but of course would never consider cleaning up their Process 2 material using this effective method.
Closer inspection of the differences between Process 1 and Process 2 reveals the tiny scale of Drug Substance - just 35 ml intended for clinical trials.
PCR amplified DNA template was used in Process 1, replaced by Linearized Plasmid DNA for Process 2.
Proteinase K was introduced at Process 2. At this point the EMA flagged the possibility of Prion contamination as discussed elsewhere.6 Their Proteinase K was manufactured without any human or animal materials, but in the purification process, a chromatographic column containing Heparin of Porcine (Pig) origin is used.
Pfizer BioNTech have attempted to minimize giving jabbees Creutzfeldt-Jakob, also known as Mad Cow Disease, by sourcing Casein Digest Peptone used in its LB broth, derived from Bovine milk fit for human consumption, from animals in Australia and New Zealand.
Note subtle differences in Table R.1-1 such as “Free from observable particles” becoming “Essentially free from observable particles” when scaled up.
Acceptance criteria for particulate contamination were lax.
Batches made in Process 1 intended for clinical trials were:
R427-P020.2-DS; R438-P020.2-DS; R443-P020.2-DS; R445-P020.2-DS
Here DS means Drug Substance.
Note that Process 2 was used to produce different Batches intended for Emergency Supply, ACMF Process Performance Qualification (Andover) and BNT-REN Process Performance Qualification (Germany).
Here is a table of some Batches produced by Pfizer in US and BioNTech in Germany.7
The source of the Batch data was a leak from the European Medicines Agency discussed in the British Medical Journal.8 Adverse events and Deaths reported to the US VAERS system were added later. Note that the author of the table assumes 5 jabs per vial, however it has emerged that 6 jabs could be obtained per vial, which could affect Adverse Reactions and Deaths per jab estimations. The important point of the data is confirmation of low mRNA integrity before and after encapsulation in the LNPs.
The identity of LMS (Late Migrating Species) contamination is a very big Question.
Pfizer BioNTech GMO Plasmid
Some technical detail where I still have Questions for experts.
Directed Evolution9 pST4-1525 plasmid that Pfizer BioNTech designed and inserted into E Coli Bacteria to manufacture the Linear DNA template and then BNT162b2 mRNA used to make human cells produce the toxic Spike Protein.
It includes code for T7 RNA Polymerase, the Recognition Sequence for the Endonuclease used for Linearization, the Kanamycin resistance gene (i.e. deliberately causes antibiotic resistance), and an origin of replication sequence.
Tell me more about Kozak, Poly(A) tail, FI element?
An excellent article describes various factories involved in making the jabs in USA.10
In Chesterfield, Missouri, the circular DNA loops are made in large vats holding hundreds of gallons of an amber-colored solution containing “specially designed E. coli bacteria”.
DNA loops are "linearized," using enzymes to cut the circles into strands of DNA which are packed into special “high-tech” bags about the size of a grocery bag and frozen to minus 112 F for storage. The bags of DNA are shipped 1,200 miles away to Pfizer’s Andover plant.
Manufacturing - Mass Production of mRNA
BioNTech is a German company that has agreements with numerous other companies in a number of countries for production and distribution of the toxic mRNA jabs.
One famous manufacturing partner is Pfizer which produces the mRNA at Andover in Massachusetts USA.11
We can presently learn more about the BioNTech Pfizer production from documents obtained from the European Medicines Agency than US sources, because the US Court ordered release of secret files is not yet complete.12
Details of the jab ingredients were covered in an earlier article.13
Pfizer change of formula to replace the Phosphate buffer with Tromethamine without any trial is covered in a special broadcast.14
Manufacturing Process 2 in Mainz and Andover BNT162b2
The chosen jab after trials was BNT162b2. This table illustrates the history of production of the Drug Substance, mRNA, in USA and Germany. One 37.6 litre batch, can make up to 10 million doses of jab.
Pfizer uses GMO Bacteria to make DNA template
Pfizer jab Manufacturing Process for BNT162b uses modified DH10B Escherichia coli Bacteria cells to grow the DNA used to make their Covid19 Spike Protein encoding mRNA. Interestingly these Bacteria have been designed to "invade" Human Cervix and Breast Cells. Even more interesting is the fact that Chloroquine assists the invasion.17
Endotoxin Contamination by Bacteria
Huge quantities of Endotoxin, up to 500 μg/ml have been found in DNA isolated by standard techniques and are known to activate the Complement System.18
In 1989 it was shown that elevated levels of the Endotoxin induced Complement the anaphylatoxins C3a and C4a are associated with a fatal outcome.19
Because the EMA has limits on the amount of toxic substance contamination in jabs caused by bacteria used in production, Pfizer BioNTech has to test and report for each batch.
Pfizer had No Control of Endotoxin in Vials
In November 2020 Pfizer stated that Endotoxin levels fell under “IPT-C” = In Process Test Control as shown in this table about the company saving money by reuse of its filters:
In March 2021, Pfizer issued a Correction stating that:
To fulfil REC15, the description and data of the verification of the analytical procedures used for in-process control test, including pH, RNA Content and Bioburden, is provided in section 3.2.P.3.5 Process Validation and or Evaluation - Verification of In-Process Test Methods (Puurs).
Endotoxin, which was previously inadvertently stated as an IPT-C, is an IPT-M and method verification is not provided. A summary of the method validation for in-process testing for RNA content was previously provided and detailed in Section 3.2.P.5.3 Fluorescence Assay.
This quote can be seen in context here:
Pfizer supplier Rentschler BioPharma failed a week long FDA inspection in February 2022 and Endotoxin was high on the list of concerns.20
Pfizer Kalamazoo, Michigan Plant mixed mRNA with LNPs
The USA Today authors tell us the 4 different LNP chemicals “are diluted with ethanol and then fed together with the mRNA into about 100 specially-produced hockey puck-sized mixers.” Then the jab liquid is “sent into a high-speed vial filling machine, which puts a precise amount into six-dose vials about the size of a thimble.”
Pfizer and BioNTech Patents
A very large World Patent Application provides a wealth of detail on the Pfizer/BioNTech mRNA development, testing and plans for mass production.21
It provides very interesting information relating to harms suffered by trial subjects, including the fact that 9 of the 10 people suffering Lymphadenopathy were Women.
The patent makes it clear that the Draining Lymph Nodes and Spleen were the deliberate target.
I suggest you use keywords to search in that patent. I certainly did and found of immediate interest:
Endotoxin, Lipopolysaccharide, Sucrose.
I was particularly impressed that they list preferred Adjuvants "Examples of adjuvants include, without limitation, LPS, GP96, CpG oligodeoxynucleotides, growth factors, and cytokines, such as monokines, lymphokines, interleukins, chemokines. The cytokines may be IL1, IL2, IL3, IL4, IL5, IL6, IL7, IL8, IL9, IL10, IL12, IFNα, IFNγ, GM-CSF, LT-a. Further known adjuvants are aluminium hydroxide, Freund's adjuvant or oil such as Montanide® ISA51. Other suitable adjuvants for use in the present disclosure include lipopeptides, such as Pam3Cys."
Note that the first Adjuvant they mention is LPS = Endotoxin deliberately left from E. coli production in to create IL-1β Storm.
We learn from the Pfizer/BioNTech patent that they are particularly fond of the Deadliest part of the Endotoxin, namely Lipid A. As my patent attorney friends told me, always expand your search, in this case to preferred term Saccharolipids.
Pfizer22 claimed “process 2 batches were within specification acceptance criterion for dsRNA and comparably low (< 240 pg / mg RNA).” Recent international news shows this to be a lie.
Update September 2023
Maria Gutschi provides more insights and documents released under FOI.23
Update October 2023 - Erika Delph discovery
One of my colleagues in the Daily Clout Team 3, Erika Delph24 has helped to identify the “Trial within a Trial” where 252 subjects were given Process 2 E. coli jabs so late in the clinical trial that they would not reported before Emergency Use Authorization was granted. She identified strange “randomization numbers” that allowed confirmation of our earlier discussions with Josh Guetzkow that identified the subscript Z as the likely identifier for lots.25 The figure uses colour to identify different jab batches. Note the Blue and Green dotted lines.
Their expanded view makes it clearer.
Note that my very good friend and former Daily Clout Team 3 member OpenVAET working with Josh Guetzkow, actually sent the Randomization Codes to Daily Clout in August 2023.26
DNAse1 can be contaminated with Endotoxin
Thanks to a recent post by Kevin McKernan, I was prompted to have a quick look at the DNAse1 used in the Pfizer production and found that DNAse1 comes with little surprises attached:
Endotoxin ≤ 0.1 EU/μg of protein by gel clotting method.27
How much Lipid A, I wonder?
Was this enough to cause measurable increase in Cardiac Deaths in jabbed versus Placebo?
How much residual Ethanol in jabs?
Were vials filled in air or another gas mixture?
What was the actual Endotoxin, dsRNA and DNA content of Process 2 Lots EE8493Z and EJ0553Z that caused the extraordinary surge in jab harms compared to the Process 1 jabs?
Thanks to an enthusiastic jabber who has had 4 Moderna and 1 NovaVax shot, and decided to invest in NovaVax, who brought a 2022 paper28 that discusses manufacture of Pfizer jabs for clinical trials, to my attention. It uses the the word “Endotoxin” 13 times. Here is a telling quote:
"We found that endotoxin control was the primary raw material risk due to its variability in raw material lots and the difficulty of its removal in subsequent downstream purification steps. Endotoxins can be introduced to the product primarily from IVT reaction components and large volume buffers used in purification."
It mentions that their Plasmid DNA contained Endotoxin measured by the Kinetic Turbidimetric Limulus Amoebocyte Lysate method and it was “≤30 EU/mg”.
Compare that with 0.036 EU/mL in their laboratory in a 300 ml container using the RT-PCR technique and the following procedure that was abandoned for Process 2.
The final mRNA manufacturing process was split into 6 primary unit operations based from the above-described process development: a DNA Linearization step, an IVT reaction step, an Ultrafiltration Diafiltration (UFDF1) step, a Chromatography step, a second Ultrafiltration Diafiltration (UFDF2), and finally Bulk Drug Substance filtration and fill. The process developed was based off of a 300 mL IVT reaction platform that is scalable in increments of 300 mL.
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War Room / DailyClout Pfizer Documents Analysis Volunteers’ Reports eBook: Find Out What Pfizer, FDA Tried to Conceal - Kindle Edition, which can be ordered here https://www.amazon.com/DailyClout-Documents-Analysis-Volunteers-Reports-ebook/dp/B0BSK6LV5D
McKernan KJ, Gustafson E and Brand AD. Methods of isolating nucleic acids using multifunctional group-coated solid phase carriers. US Patent US7527929B2. https://patents.google.com/patent/US7527929B2/en
Tinari S. The EMA covid-19 data leak, and what it tells us about mRNA instability. https://www.bmj.com/content/372/bmj.n627
Wicks IP, et al. 2008. Bacterial Lipopolysaccharide Copurifies with Plasmid DNA: Implications for Animal Models and Human Gene Therapy. https://www.liebertpub.com/doi/10.1089/hum.1995.6.3-317
Hack CE, et al. 1989. Elevated plasma levels of the anaphylatoxins C3a and C4a are associated with a fatal outcome in sepsis. https://www.amjmed.com/article/0002-9343(89)90224-6/pdf
Joseph Keanan. 14 June 2022. Rentschler slapped with FDA Form 483 citing lax manufacturing procedures. https://www.fiercepharma.com/manufacturing/rentschler-slapped-form-483-citing-lax-manufacturing-procedures
Marjoh NAUTA, Dirk Jozef Peeters, Tom Frank Steven VAN DOORSLAER, Advait Vijay Badkar, Ramin Darvari, Nicholas William Warne, James JEAN, Danny Pierre G. HENDRIKSE, Ugur Sahin, Alptekin GÜLER, Andreas Kuhn, Alexander Muik, Annette VOGEL, Kerstin Walzer, Sonja Witzel, Stephanie HEIN, Özlem TÜRECI. 2020. Coronavirus vaccine. WO2021213945A1. https://patents.google.com/patent/WO2021213945A1/en
EMA Rapporteur Rolling Review critical assessment report. Quality aspects. COVID-19 mRNA Vaccine BioNTech. Modified mRNA, encoding full length SARS-CoV-2 spike proteinEMEA/H/C/005735/RR/xxx
Report 86: Pfizer’s Clinical Trial ‘Process 2’ COVID Vaccine Recipients Suffered 2.4X the Adverse Events of Placebo Recipients; ‘Process 2’ Vials Were Contaminated with DNA Plasmids. https://dailyclout.io/pfizer-process-2-vaccine-had-2-4-times-adverse-events/
Josh A Guetzkow and Retsef Levi. 2023. Rapid Response:Effect of mRNA Vaccine Manufacturing Processes on Efficacy and Safety Still an Open Question. https://www.bmj.com/content/378/bmj.o1731/rr-2
Jill Whitley, Christopher Zwolinski, Christian Denis, Maureen Maughan, Leonie Hayles, David Clarke, Meghan Snare, Hong Liao, Sean Chiou, Tina Marmura, Holly Zoeller, Ben Hudson, John Peart, Monica Johnson, Amelia Karlsson, Yunfei Wang, Cynthia Nagle, Cherell Harris, Daniel Tonkin, Stephanie Fraser, Lieza Capiz, Christina L. Zeno, Yvonne Meli, Diana Martik, Daniel A. Ozaki, Amy Caparoni, Jason E. Dickens, Drew Weissman, Kevin O. Saunders, Barton F. Haynes, Gregory D. Sempowski, Thomas N. Denny, and Matthew R. Johnson. 2022. Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials. https://www.translationalres.com/article/S1931-5244(21)00282-6/fulltext