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His 75% share in Porton Biopharma Ltd. Open letter to Mel Stride MP for Central Devon 30-04-2020

A friend via the net, has found that the Secretary of State for Health has a 75% stake in Porton Biopharm.  (Later - in fact a 100% stake!) This is a so called pharmaceutical company that has its facilities in a 'science park' adjoining the top secret biological and chemical weapons laboratory on Porton Down, Wiltshire.  Its web site trumpets that it produces an anthrax vaccine for the UK's armed forces.  This is of interest since germ warfare is banned internationally.

Investigation via Companies House showsthat this company was set up by a Mr Michael Brodie and registered 27-11-2014.  Proposed register office address -  1, Park Row, Leeds UK  LS1 5AB   Service address - Wellington House, 133-155 Waterloo Road, London SE1 8UG


This is the address of Public Health England.  It seems that Mr Matt Hancock has 'inherited' this stake by virtue of his appointment as Secretary of State for Health from his predecessor, the most veracious Jeremy Hunt. Many questions arise.  My MP, Mr Mel Stride has been asked a few.

Further investigation by George Antoniou has revealed this below.  It is not known what followed this condemnation of Porton Biopharm  by the US Food and Drugs Administration.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/porton-biopharma-limited-509689-01172017

'Erwinase' https://en.wikipedia.org/wiki/Asparaginase


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 (21 CFR 211.192).

Quote Your firm also detected fibers in the lyophilized product of five finished units of lot CAMR171. The fibers were later identified as cardboard or paper. Your firm did not adequately investigate the potential sources of this unusual extrinsic contamination in your sterile drug product.

In addition, in October 2016, your firm submitted additional batch records for batch CAMR178, documenting that this batch contained visible particulate matter of (b)(4) origin. In December 2016, your firm submitted batch records for batch CAMR179, documenting that the batch contained visible particulate matter including that of proteinaceous nature. Your investigations indicated that these additional instances of contamination are likely from another source besides the stoppers and call into question your ability to prevent contamination.

Your firm has failed to implement prompt and sufficient corrective and preventive actions to resolve the hazard posed by foreign contaminants in your injectable products. The continuing presence of various types of visible particles in Erwinaze®batches is evidence of an insufficient assessment of all potential manufacturing failure modes and an overreliance on finished product visual inspection.  
 

Additionally, your firm does not have appropriately strict action limits for certain individual defect categories, including but not limited to particles that are extrinsic to the process (e.g. fiber or cardboard).

2.    Your firm failed to establish and follow appropriate written procedures, designed to prevent microbiological contamination in drug products purporting to be sterile (21 CFR 211.113(b). 

Conclusion
 
Violations and deviations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations and deviations, for determining the causes, for preventing their recurrence, and for preventing other violations and deviations.
 
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at This email address is being protected from spambots. You need JavaScript enabled to view it., so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.      
 
Until you correct all violations and deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
 
Failure to correct these violations and deviations may also result in FDA refusing admission of articles manufactured at Porton Biopharma, Limited, Manor Farm Road, Porton Down, Salisbury, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
 
After you receive this letter, respond to this office in writing within 15 business days. Specify what you have done since our inspection to correct your violations and deviations and to prevent their recurrence. If you cannot complete corrective actions within 15 business days, state your reasons for delay and your schedule for completion.
 
Because these violations and deviations are significant and repeated, it is urgent that corrective action is taken as soon as possible. FDA will contact your firm to schedule a face-to-face regulatory meeting between your firm, your customer, and Agency officials. The purpose of this meeting is to ensure your firm is taking prompt actions to correct the violative conditions found during the 2015 and 2016 inspections discussed in this Warning Letter.
 
Send your electronic reply to CDER-This email address is being protected from spambots. You need JavaScript enabled to view it.or mail your reply to:
 
Marisa Heayn
Consumer Safety Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA

 


Dear Mr Stride,

This is an open letter given the importance of the subject and in the face of universal deceit, and the blackest of propagandere nerore ‘Covid’. First though I need to know whether you have heard from Mr Buckland, the Lord Chancellor. You will recall that I pleaded with many others for the release from unlawful imprisonment of the journalist, Julian Assange. He has been ‘guilty’ of reciting the war crimes of the US and GB in Iraq and elsewhere, crimes equivalent to those of the Third Reich for which some German leaders were hung. Unfortunately, and symbolically, the Nuremberg Protocols have not been bound into English law!



Dear Mr Halpin,  06-04-20 11.54 am

Thank you for your e-mails. 

You should have received an auto-response to your earlier e-mail, which was not diverted to junk.  My apologies that this did not come through. 

I have shared the text of your original e-mail on Mr Assange with the Lord Chancellor and will let you know when I have a response. 

Thank you again. 

With best wishes, 

Mel



1. Julian Assange - his crucifixion within a totalitarian state - on windswept marshes. No Golgotha gathering allowed. ...

(Correspondence With Politicians)
... have shared the text of your original e-mail on Mr Assange with the Lord Chancellor and will let you know when I have a response. Thank you again.   With best wishes, Mel   ...
Created on 28 February 2020

2. Julian Assange - TORTURE ...

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Julian Assange Likely to die in Bellmarsh Prison 11-11-19 Dear Mr Stride, I assume that you have not read the account by Craig Murray when he attended the Westminster Magistrate's Cour ...
Created on 11 November 2019

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... he attached  https://www.craigmurray.org.uk/archives/2019/10/assange-in-court/   David Halpin MB BS FRCS   'Do your best to heal, and not to harm'.  DSH - adapted from a surgical maxim      ...
Created on 23 October 2019

4. To the Right Honourable Robert Buckland QC MP Lord Chancellor and Secretary of State for Justice

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... remand. We have written as doctors in great concern about the journalist Julian Assange who is one of those prisoners on remand. There is all evidence that his physical and mental health is in the ...
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5. Government

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... ng these issues. As you will see from my published article the question I posed regarding Julian Assange goes way beyond his individual injustice. In fact it goes right to the heart of government. W ...
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Mr Hancock. Please read

https://beta.companieshouse.gov.uk/company/09331560/persons-with-significant-control

and see ‘filing history’. Note that Mr Jeremy Richard Streynsham Hunt preceded M.J.D. Hancock as the major shareholder in this private ‘biopharm’ company and with the use of the publicly owned Richmond House as the correspondence address.

Many questions arise out of this. These come to mind.

1. What was the purpose in the UK Secretary of Health (SoS) being the central figure and shareholder in a private ‘pharmaceutical’ company?

2. Was private or public money used in the purchase of shares?

3. What is the legality, aside from the morality, of Richmond House being the correspondence address?

4. What is your own view of the propriety of the SoS, first Hunt, and now Hancock, taking any part in a private company.

5. The laboratory of this company, which has the trappings of a normal company

https://www.portonbiopharma.com/management/pbl-board/is located in the ‘science park’ at the Porton Down bioweapon ‘defence’ facility – top secret in its functioning and purpose. Is this a likely place for a pharmaceutical company?

6. You see that it has the sole contract for the production of a vaccine against the bacillus anthracisorganism for use if ever necessary by our armed forces. So the SoS has a hand in the production of this vaccine, be it with the use of fertile chicken eggs or cell culture. Please ascertain what payments are being made by the MoD for this vaccine, given that our taxes are the source.

7. In order to produce the vaccine, the antigen is needed. The storage and culture of this organism will be strictly controlled by H&S measures and by statutes. How does Porton Biopharm acquire it, and under what legal and ‘biosafety’ rules or does it purchase the purified antigen alone from its ‘high security’ neighbour.

8. The Certificate of Incorporation 27thof November 2014 has the address of 1,Park Road, Leeds, LS1 5AB https://www.192.com/places/ls/ls1-5/ls1-5ab/- at least 20 businesses including the solicitors Pinsent Masons LLP. Why was this the address?

9. The address used by Michael Brodie, who sought the certification I assume, was given as Wellington House, 133-155 Waterloo Road, London SE1 8UG. I see this is the home of Public Health England and NHS ’Improvement’ - formerly Monitor.

a. Who is or was Mr Brodie in 2014, and what position did he hold?

b. Was it a salaried and public service role?

c. To be specific, was he employed by an arm of the NHS bureaucracy, post- 1stApril 2012 Health and Social Care Bill?

I look forward to your replies in this important and public matter

for truth

David Halpin MB BS FRCS