Kymriah GMP issues in NJ led to FDA letter for Novartis—Is gene therapy on its last legs?

This is Dynamite!!!

Kymriah GMP issues in NJ led to FDA letter for Novartis

This is potentially a watershed event:

The US FDA has highlighted GMP deficiencies in the production of CAR-T therapy Kymriah at Novartis’ Morris Plains plant.

In November and December last year, the United States Food and Drug Administration (FDA) inspected the Morris Plains, New Jersey facility, resulting in it issuing a Form 483 [inspection report] with an undisclosed number of observations to Novartis. This is an extract:

Among the deviations, the Agency found Novartis failed to establish laboratory controls, particularly citing sampling plan and test procedure issues relating to freezing bags – or ‘Cryobags’ – the primary container for Kymriah.

“[The plans] are not appropriate to assure that Cryobags are “free of…particulate matter” as required by your acceptance criteria,” the Agency states. “Between December 2018 and the date of the inspection, you identified approximately 100 batches of Kymriah contaminated with foreign particulate matter, such as wood, cellulose, brass, and steel.

In November 2020, your firm concluded the Cryobags were the most probable root cause.

The full article is here:

Kymriah GMP issues in NJ led to FDA letter for Novartis

Novartis promised to remediate, but the problems were found to continue. This is the letter FDA sent that has recently been released:

August 08, 2023, FDA letter to Robert Zamboldi, Site Head, Novartis Pharmaceuticals Corporation, 220 E. Hanover Ave. Morris Plains, NJ 07950

Please, do read the letter. It is way beyond shocking: wood, cellulose, brass, and steel. In November 2020, your firm concluded the Cryobags were the most probable root cause.

FDA showing its teeth

Now FDA has its teeth into this, I can’t see them letting go. This is what FDA always did best—used their powers under the Code of Federal Regulations, Title 21, to close down facilities and even go in there to take them over under a Consent Decree.

This follows on from this previous post on FDA inspection findings:

It’s not a secret—Fierce Pharma is reporting it!

FiercePharma is reporting horrific FDA findings at facilities manufacturing the SARS-CoV-2 injections. In spite of this proven substandard manufacture, they are still pumping out products that are potentially adulterated—which means they should cease production immediately. Let’s take a look at some of what Fierce Pharma has published, including copies of the reports FDA issued:

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

“On Tuesday night, the FDA released (PDF) a Form 483 notice it had sent to Catalent, citing 12 observations from a lengthy August inspection of its Bloomington, Indiana, site. The massive facility is among the largest in the portfolio of contract manufacturing powerhouse Catalent. Most of the observations had to do with quality control, record keeping and the failure to establish and follow procedures. The FDA noted a failure to address unexplained discrepancies in a batch of drug product.”

See FDA inspection report: FDA Form 483

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures

“Inspectors found the facility’s simulated fill process lacked a revolutions-per-minute specification for the pump and that there was no documentation for RPM settings during drug substance dispensing. Additionally, two pieces of equipment had discolored rings below the top of the assembly, but no cause for the discoloration was indicated and no formal risk assessment or corrective action to address the discoloration had been taken, inspectors said.

The regulatory agency also cited the plant for not having lab procedures or testing to assure compliance with established specifications and standards available. Other equipment supporting manufacturing operations were not adequately validated, either, the FDA said.”

See FDA inspection report: FDA Form 483

Catalent’s Belgium operations get a second FDA scolding within 1-year span [Catalent again slammed by FDA]

“In the wake of an FDA inspection conducted between August 10 and August 18 at the Brussels plant, the company received a total of nine observations. Inspectors highlighted problems with air filters in aseptic areas, deficient changes to the HVAC system, and other equipment-related issues. Additionally, inspectors found that backup data was not being verified, and the facility lacked procedures for “receiving and control of customer designs."

See FDA inspection report: FDA Form 483

Why no action from FDA—it has the powers?

Many critical thinkers reading this won’t be surprised at the lack of action. We know that the contracts Governments and its agencies signed offered no protection for unsuspecting people who believed the historic good practices of developing, manufacturing and distributing drugs were still being observed.

All I can say is that Mother Nature has a wonderful way of bringing liars and scoundrels to book, even if it takes a very long time!

CAR T is what is was about all along

Kymriah was $475,000 (to treat a single patient) when it launched in 2017. It’s still nowhere near blockbuster status and neither are any of the other CAR T products.

The volumes are just too small.

The only way to keep investors happy was to do what they did - convert them into ‘vaccines’. Remember, Trevor Mundel joined Bill Gates in 2011, having been VP R&D at, yep, Novartis!

He’s been busy ever since masterminding the capture of the industry.

So, have a think about this and I’ll be back as soon as there is more news to share.