The inside story on DNA 'vaccine' supply chains—Part 3
Virtual companies can't develop drugs
Conclusion in Part 2
In Part 2, we concluded the following:
“BioNTech has no skills or experience in the development and manufacture of complex, biologic products, let alone gene therapy products. It should never have received a licence to manufacture SARS-CoV-2 injections.”
That should have been a red flag to regulators and governments around the world, but it wasn’t. The alleged pandemic, apparently, was more important.
That followed on from Part 1, where we learnt that BioNTech is a ‘virtual company’.
A virtual company is one that owns little other than its intellectual property rights (IPR = patents), and business acumen. All the extensive physical activities required to bring a drug to preclinical and clinical trials, plus for commercial sale, are outsourced to third party organisations (CDMOs and CROs).
We also discovered in Part 1 that a manufacturer of their drug substance (DS, or Active Pharmaceutical Ingredient - API) had received a scathing inspection report from FDA:
“Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping.” This is the Form 483.
That’s enough to close a site down for months or even years, but they have been allowed to carry on. It should be glaring obvious, however, that BioNTech has no ability to carry out the oversight to correct these critical issues.
Part 3: Moderna, another virtual company with a virtual supply chain presence
In Part 3, we move on to Moderna, which has an almost identical business model to BioNTech. It also has the same inability to develop and commecialise medicinal products.
First, a recap on the manufacturing supply chain for a biologically derived medicinal product (gene therapy is in that category).
The diagram below shows the various stages. Aside from raw materials, which have quality controls, but not as stringent as those downstream, all other stages must adhere to Good Manufacturing and Distribution Practice.
Starting materials are typically animal or human cells of some kind.
The next stage is upstream processing. Upstream processing refers to where biomolecules are grown, usually by bacterial or mammalian cell lines, in bioreactors.
When they reach the desired density, they are harvested and moved to downstream processing.
The purpose of downstream processing is to isolate, purify and concentrate the drug substance (DS) received from upstream processing, and then contain into a primary container. In our case, a sterile, sealed vial. Traditionally, vials are filled and capped individually with a single dose, then packaged in a carton, with a patient information leaflet.
For the Pfizer and Moderna injections, that did not happen, as we know. Additionally, they were frozen, so could not be processed into finished, unit-dose products, in the traditional way. That is a major issue.
Biologics are tricky things to manufacture
It is important to remember that biologics are an order of magnitude trickier to produce than small molecule products. Small-molecule products can be reproduced reasonably accurately, independent of the facility and equipment used to make them. In biologics, the molecules are so large and complex that it is often impossible to define their molecular structures by analysis. All that is known is that a particular process has produced something that has a particular biological effect on a patient.
Other manufacturers may not be able to replicate that product and its clinical effect, even if the process appears to be the same. That has led to the industry mantra for biologics supply chains that “the process IS the product.”
Another complication is the sensitivity of biologics to temperature variation and other environmental factors (remember they are living things). The exact temperature range products and materials must be stored and transported at must be established, registered, and kept to. Temperature data loggers are used to monitor temperatures throughout storage and transportation. Excursions outside a given range, say +2˚C to +8˚C, must be investigated and corrective action taken.
Input materials can also be problematic. They can dramatically affect yield, potency, and quality of output, as the strength (titer) of each new supply of materials can vary widely, depending on factors that are not always obvious to the acquiring company. Getting pedigree information from suppliers, especially when the upstream supply chain leads to seemingly anonymous donors, can be a nightmare and sometimes even impossible.
So, this is what tiddlers like Moderna and BioNTech claim to have managed successfully. I don’t think so somehow!
On to Moderna and its quality issues
Moderna suffers from the same unresolvable issues as BioNTech—it does not have the critical mass to develop even simple small molecule products, let alone biologics also classed as gene therapies.
More is explained here:
FDA unearths a minefield of quality issues at the contractor manufacturing Moderna's jabs FDA Form 483
This is an extract:
“It contains substantial findings that could leave a person wondering if that plant can go on operating without major corrective actions—that would take months if not a year or two, as these are deep rooted issues. These are the first four Observations made:
OBSERVATION 1
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
OBSERVATION 2
Written records of an investigation of drug complaint do not include the findings of the investigation and the follow-up
OBSERVATION 3
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in characteristics of the in-process material and the drug product.
OBSERVATION 4
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to ensure that batches of the drug product meet appropriate statistical quality control criteria as a condition for their approval and release.
The remaining OBSERVATIONS 5 - 12 can be viewed on the link above or here.
It makes chilling reading if you have even the slightest idea of how errors in the supply chain can impact product safety.”
Have no doubt, in pre-COVID this would have been reason for FDA to issue a consent decree at the very least, which includes ‘special measures’ being applied to stop production and ensure remediation activities are complete before resuming production. In this case, it could lead to stopping these virtual companies altogether.
Finally, I am still optimistic that FDA can weigh in here. This is some thinking on the topic.
It concludes:
“Having read this, you are probably thinking that FDA has been complicit in this all along, so why would they be on our side?
My view is that CDC, Fauci, Gates et al used Committees to push their evil agenda through. Now the globalists have been found out, the silent majority at FDA are pushing back by using the powerful tool of physical inspections—that’s what I think anyway…”