On 'critical quality attributes' or CQAs
On 'critical quality attributes' or CQAs
Orientation for new readers; American Domestic Bioterrorism Program; Tools for dismantling kill box anti-law
In recent months, as I’ve learned more about the non-regulatory, fraudulent character of FDA’s purported oversight of biological product manufacturing, I’ve tried to convey a few key points.
Vaccine manufacturers, FDA and the FDA’s regulatory partner — the US Pharmacopeia-National Formulary — have never established any objective, measurable, verifiable physical, chemical or biological standards for gene-containing, cell-based products including but not limited to products labeled as vaccines.
Pharmaceutical manufacturers, FDA and USP-NF have never identified or developed techniques or equipment that can validly measure physical, chemical and biological characteristics of vaccines and related biological products.
And FDA has never enforced, on vaccine manufacturers, compliance with any objective, measurable, verifiable physical, chemical or biological standards for vaccines and related biological products, because such standards have never been established and do not exist.
I have argued that these failures are attributable to the inherent heterogeneity, instability and toxicity of biological material contained in vaccine packages.
In each vial and each dose, there is a wide variety of genetic material, along with other, non-biological substances such as metals.
At every step along the path, from the raw materials and cell lines propagated in the factories, to the moment of injection and after the contents enter the living human or animal body, genetic material is prone to decay, fragmentation, sedimentation, protein-folding, and other transformations.
It is not in stasis; it is dynamic; it is unstable.
And the genetic material, because it is foreign to the person receiving it and living creatures are designed to respond defensively to invasions of foreign matter, is harmful to the recipients.
It is toxic — to a greater or lesser degree depending on infinite variables — to every person who receives any vaccine, each time such invasion occurs.
There is no way for anyone to know even the identity of the biological material in the vials, and thus also no way for anyone to know the purity, potency, safety or efficacy of genetic material whose identity is unknown.
All vaccines, up to and now including mRNA/LNP vaccines, have always contained genetic, cell-based material foreign to the recipient.
All vaccines, up to and now including mRNA/LNP vaccines, have always caused harm to the recipients.
In the last couple of days, I’ve come across reinforcement of these points from several sources.
Without providing in-depth analysis, I’m offering some quotes and links for readers who want to study and think about these things more, to further develop confidence in decisions to stop taking all vaccines and stop all vaccination of babies and children.
The sources cited below support the conclusion that the inherent heterogeneity, instability and toxicity of vaccines has been known to manufacturers, fake-regulators and vaccination proponents for a very long time.
For more than 100 years, and still today, US and international government and non-governmental agents have advocated and coerced public submission to vaccination as an intentional program to deceive, harm and kill people.
Critical Quality Attributes
An important phrase to learn is “critical quality attributes.”
I first heard it in June 2024 during a conversation with a pharmacist about the relationship between FDA and the US Pharmacopeia-National Formulary, and about USP-NF employees’ efforts, in recent years, to grapple with mRNA/LNP vaccines and other novel genetic, cell-based products.
FDA has defined CQAs as
“a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.” (November 2009, FDA Guidance for Industry Q8 (R2) Pharmaceutical Development)
CQAs are related to all the things that Sasha Latypova has investigated and written about, concerning Chemistry, Manufacturing and Controls (CMCs), and the complete non-applicability and non-enforcement of CMCs to Covid vaccines, including her December 2022 memo to Senator Ron Johnson.
Again, without trying to contextualize the information, apart from a few brief comments, below are the sources I’ve come across in the last few days.
1910 - Vaccine Virus, paper by Milton J. Rosenau, [second Director of Public Health and Marine Hospital Service Laboratory of Hygiene, 1899-1909], published by JAMA
Vaccine virus is the specific principle in the material obtained from the skin eruption of calves having a disease known as vaccinia [cowpox]…
Both the pulp and the lymph are mixtures containing epithelial cells, serum, blood, leucocytes, products of inflammation, debris, bacteria, etc., in varying proportions.
The specific principle of vaccinia [cowpox] is unknown…
It is impossible to obtain vaccine virus free from the bacteria of the skin…
The fact that a serum or vaccine is granted a license does not mean that it is a valuable curative or prophylactic; in fact, it may have little or no therapeutic value…
Why vaccine virus should be in the Pharmacopeia…
The objection, that vaccine virus is an indefinite substance, the ‘active principle’ of which is not known, is no longer valid, for the Pharmacopeia contains many such substances, including the ferments, against which similar objection holds.
The objection that vaccine virus cannot be “assayed” [quantitatively and qualitatively analyzed to determine the presence, amount or functional activity of a substance] by the average druggist also lacks force when we recall that the potency and purity of vaccine virus in interstate traffic is cared for by the federal government under the law of July 1, 1902, which relieves the pharmacist of this responsibility…
KW comment: Rosenau asserted that the presence of other undefined substances in the Pharmacopeia, meant that pharmacists should have no problem handling and dispensing the undefined substances contained in vaccine packages.
Rosenau further asserted that, although the unknown and unknowable contents of vaccine packages couldn’t be objectively analyzed by anyone, including dispensing pharmacists, pharmacists should not be concerned about it: the federal government had legally relieved them of responsibility for the contents of vaccines.
2010 - Sequence-Based Classification of Select Agents, A Brighter Line: Committee on Scientific Milestones for the Development of a Gene Sequence-Based Classification System for the Oversight of Select Agents (National Academies of Sciences, Engineering and Medicine)
“…Natural variation and intentional genetic modification blur the boundaries around any discrete list based on taxonomic names…
The committee was specifically charged with identifying: the scientific advances that would be necessary to permit serious consideration of developing and implementing an oversight system for Select Agents that is based on predicted features and properties encoded by nucleic acids rather than a relatively static list of specific agents and taxonomic definitions.
It is implicit in the charge that a “predictive oversight” system is not now feasible. It is also implicit that “gene sequence-based classification,” is synonymous with “predict[ing] features and properties encoded by nucleic acids.”
However, it soon became clear that the committee was confronted by two quite different tasks, one of which is feasible and one is not. It is possible to classify a new sequence as belonging within a group of known sequences; it is not feasible to predict the function(s) that sequence encodes. Thus, it is essential to distinguish sequence-based classification from sequence-based prediction of biological function.
A sequence-based prediction system for oversight of Select Agents is not possible now and will not be possible in the usefully near future.
Select Agent is not a biological term; rather it is a regulatory designation. Some properties historically considered in assigning an organism to the Select Agent list are not biological properties, and therefore, can never be determined from the organism’s genome sequence.
High-level biological phenotypes—such as pathogenicity, transmissibility, and environmental stability—cannot plausibly be predicted with the degree of certainty required for regulatory purposes, either now or in the foreseeable future.
Reliable prediction of the hazardous properties of pathogens from their genome sequence alone will require an extraordinarily detailed understanding of host, pathogen, and environment interactions integrated at the systems, organism, population, and ecosystem levels. It is a prediction problem of the greatest complexity.
Biology is not binary. Microorganisms are not either “potential weapons of mass destruction” or “of no concern.” No single characteristic makes a microorganism a pathogen, and no clear-cut boundaries that separate a pathogen from a non-pathogen. Pathogenic microorganisms are not defined by taxonomy; it is common for a given microbial species to have both pathogenic and non-pathogenic representatives. An agent has multiple biological attributes, and the degree to which these are expressed fall along a spectrum for each biological characteristic; (1) consequently, agents present varying degrees of risk.
For the foreseeable future, the only reliable predictor of the hazard posed by a biological agent will be actual experience with that agent…
…The scientific community does not have sufficient knowledge to create a novel, viable life form, even a virus, from the bottom up. Designing an infectious viral genome de novo by sequence requires the accurate prediction of protein structure and function, the design of protein-protein interactions and protein machines, all of which must produce progeny virions efficiently in an order of magnitude more complex host cell.
If we cannot predict protein structure and function on the basis of sequences with any accuracy, how can we design and synthesize novel viruses that will replicate, regardless of their disease potential?
KW comments:
There is no ‘bright line’ or even the possibility of a bright line, distinguishing cell-based biological weapons — ‘select agents and toxins,’ in HHS regulatory language (42 USC 262a; 42 CFR 73) — from vaccines and other biological, genetic, cell-based products.
And because it is not feasible to predict biological functions of encoded sequences, for the purposes of classifying a sequence as a select agent or biological weapon, it is also not feasible to predict biological functions of encoded sequences in terms of their therapeutic value as treatments or prophylactics.
In other words, there is no scientifically-feasible foundation upon which vaccine manufacturers, regulators, advocates or users can make any valid, verifiable, credible, trustworthy claims about the identity, purity, potency, safety or efficacy of vaccines and other genetic products.
2017 - Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop (National Academies of Sciences, Engineering and Medicine)
…Although regenerative medicine has great potential for producing both health and economic benefits, this relatively new field faces unique regulatory and manufacturing challenges. The reliance of regenerative medicine products on living cells and tissues, which are inherently dynamic, adds a fundamental complexity to the manufacturing and scale-up process that is not present in the manufacture of most non-biologic therapies.
Since the variety of cells and tissues used in regenerative medicine is vast and the characteristics of cells can differ between in vitro and in vivo environments, defining and assessing the quality of products is challenging.
In addition, it can be difficult to accurately measure or test for critical quality attributes (CQAs) (i.e., physical, chemical, biological, or microbiological characteristics that should be within an appropriate limit, range, or distribution in order to ensure the desired product quality (2) of cells because these attributes can change over time as they are affected by the cell maturation process and exposure to environmental stimuli.
…[O]n June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC…to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufac turing of regenerative medicine therapies. (4)
The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring CQAs.
While there are increasingly more regenerative medicine products in the clinical pipeline and on the market, there is not yet consistency in the approaches to cell sourcing, product characterization, manufacturing processes, or logistics and delivery models…
Inherent Challenges to Preparing and Regulating Biologics
Many of the approaches and practices that the day’s presentations and discussions would highlight are rooted deeply in the history of biologics development, said Jay Siegel, a forum co-chair and the chief biotechnology officer and head of scientific strategy and policy at Johnson & Johnson.
Vaccine production is centuries old, he noted, with the use of antisera products to treat infections going back to the 1890s. Monoclonal antibodies and cell and gene therapies are examples of more recent biologic products used to treat disease.
Although each of these biologics has its unique manufacturing obstacles, he said, they share common challenges, such as difficulty in characterizing the final product and the variations that inherently occur when living cells and tissues from several different sources are used.
Unlike the case with non-biologic drugs, there is no method to sterilize a cell-based biologic in its final packaging, Siegel said, and the cell-based biologics can be reactive, immunogenic, and relatively unstable.
Related:
July 11, 2024 - On "unavoidable, adverse side effects" as deceptive language used to conceal the intentionality of vaccine toxicity. - “…SCOTUS is on board with the vaccine-mediated cull; they've already addressed it through Bruesewitz v. Wyeth (2011)…A key phrase from Bruesewitz, citing Hurley v. Lederle (1988), identifies the FDA as a “passive agency,” which is code for non-regulatory, having no legal authority or historical record of setting or enforcing standards for vaccine design, identity, safety, or efficacy…Scalia opinion at p. 13: “Design defects…do not merit a single mention in the [1986 National Childhood Vaccine Injury Act] or the FDA’s regulations. Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.”
Aug. 26, 2024 - Intentional elusivity of definitions for virus and vaccine.
