The inside story on DNA 'vaccine' supply chains—Part 1

J K Rowling would have difficulty making it up...

This is a re-cycling of a series of INSIDE PHARMA posts from October 2022. It was true then, and it’s still true today:

What’s this about?

Yesterday’s newsletter finished:

“Over the next 5 - 7 days, I’ll be digging into more [on BioNTech supply chains] and also the other companies in the SARS-CoV-2 ‘vaccine’ fraudulent development, manufacturing and distribution supply chains.

It really is gob smacking (excuse technical terminology) to realise they thought to get away with this—Mother Nature has laid down her laws that can never be short cut.

Her retribution will follow as sure as night follows day—she fixed that too :O).

I’m not abandoning free subscribers, of course, but the upcoming 5 - 7 days from tomorrow will be for paid subscribers only. If you want to help me keep going, and learn a ton of what’s been going on in the ‘vaccine’ supply chains”:

If you have not run your eyes over this, it’s worth doing it now, if you’ve time:

BioNTech—the virtual company with a virtual moral compass

You will hear: “Only ever having procured material for Phase 1 clinical trials in melanoma, using contract manufacturers, BioNTech takes on a full scale, commercial manufacturing plant!!! It also seems it had another two manufacturing plants that have appeared from nowhere.

Hopefully, you are taking in the impossibility of what has happened here.”

What is ‘virtual’ drug development?

Virtual drug development emerged following Big Pharma’s mass outsourcing of its physical assets—facilities and people skills—to third party contractors. It began in the early 1980s and has carried on afoot ever since. That was followed by Big Pharma outsourcing drug development, as well as its facilities and people skills, to reduce exposure to failed early stage clinical trials (it didn’t).

Enter virtual pharma, small companies using the third party contractor base to develop one compound, sometimes a couple, they had high hopes for.

In the early days of virtual pharma (1995 - 2005s) the virtual pharma companies had all the drug development skills in-house and managed the contractors to progress compounds through the development lifecycle. I worked for two that managed to get drugs to market, one a triptan (2002 for migraine) and the other a drug for non-small cell lung cancer (2004).

As time went by, virtual pharma became smaller and smaller, and the contractor base consolidated, to create powerful corporations, skilled at striking tough deals.

Today, if you look at the websites of the thousands of virtual pharma companies developing drugs at very early stage, the senior teams mainly comprise CEO plus finance, marketing, legal, scientific discovery, business development, alliances…with little or no expertise in the tricky business of getting drugs to market.

This is how the BioNTech team looks:

From Discovery to Delivery – Meet our Senior Team

This is the Moderna leadership Team [page not found today!]

This is the virtual pharma of today—top heavy management boards with little or no experience of developing new molecular entities for patient markets.

Yet, we are led to believe they have done it.

You can read more on industry ‘virtuality’ here:

SARS-CoV-2 INJECTIONS ARE PHYSICAL, NOT VIRTUAL

Where does the supply chain come in then?

The physical supply chains, from beginning to end, are in the hands of the contractors and other third party operators. In theory, the virtual pharma companies are responsible for everything that goes on, and wrong, in the supply chain—that’s pharmaceutical law.

In practice, oversight of contractors has regressed markedly over the years to the point where supply chains (remember they make what goes into your body) for the SARS-CoV-2 injections received no oversight whatsoever.

That was aided and abetted by Regulatory Authorities (eg FDA/EMA/MHRA) stopping carrying out their obligations to inspect companies in the supply chain on a regular basis. They relied on ‘distance’ inspections, due to the ‘emergency’.

Luckily, FDA has carried out inspections more recently, with shocking results.

FDA unearths a minefield of quality issues at the contractor manufacturing Moderna's jabs

It reveals an FDA inspection of a facility manufacturing the Drug Product for Moderna:

Moderna's new booster launch tripped up by production issues at Catalent plant

If FDA find issues, they write up a Form 483. This one is horrific:

Catalent Form 483. If it were a restaurant, it would be shut down immediately!

A company listed as a manufacturer of Pfizer/BioNTecH’s BNT162b2 Drug Substance

We know from documents sent voluntarily by Pfizer insiders to the wonderfully investigative Sasha Latypova, that Rentschler Biopharma, Laupheim, Germany, is a company listed as a manufacturer of BNT162b2.

This is an article published Jun 14, 2022 in FiercePharma reporting on massive quality non-compliances at the company:

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures By Joseph Keenan.

It states “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.

This is another horror story. Note, the form 483 is addressed to Rentschler’s ‘Chief Scientific Officer’. Any Chief Scientific Officer at a drug development company will know diddly squat about cGMP manufacturing. Yet, he is expected to carry out the remediation activities. Snowball’s chance in hell…

…but wait, what’s this?

“London, UK, and Laupheim, Germany, February 11, 2021 - The Cell and Gene Therapy Catapult (CGT Catapult), an independent centre of excellence in innovation advancing the UK's cell and gene therapy industry, and Rentschler Biopharma SE, a leading global contract development and manufacturing organisation (CDMO) for biopharmaceuticals, have announced today that Rentschler Biopharma will establish their manufacturing capability in Advanced Therapy Medicinal Products (ATMPs), including Adeno-Associated Virus (AAV) Vectors for clinical trial supply, at the CGT Catapult site in Stevenage.”

Read the full press release here:

February 10, 2021 Rentschler Biopharma entry into cell and gene therapy

You couldn’t make this stuff up!!!

Part 2 will be along soon and it doesn’t get any better…