Hedley Rees with PANDA UNCUT – a 42 minute video – Understanding the challenges in manufacturing and distributing products derived from biologics - Warp Speed = Warped Crap
The excellent Hedley Rees details each step, from design to injection of the manufacturing process and describes the Form 483 issued by top quality FDA inspectors that should have shut down key suppliers to both Pfizer and Moderna - IGNORED BY FDA AND PETER MARKS – plus a host of other missed steps and missteps of the injections into arms.
He spells out why it takes more than 3 years to get to the clinical trail stage, not minutes and why it takes many more years to pass through clinical trials – not weeks.
“The pharmaceutical industry was founded on small molecule products, where active ingredients were manufactured by fine chemical companies using long-established industrial processing. That meant the final dosage forms had excellent stability profiles with a typical shelf-life between two to five years.
The simple chemical structures meant that different producers’ products could be tested against specifications and proven to be equivalent and therefore interchangeable. Storage conditions, in the main, were controlled room temperature (20°C), which was relatively easy to maintain within the required +/- 5°C in pharmaceutical warehouses of the day.
Fast forward to today’s industry and the emergence of biologics—products made from living things. With the success of biologics such as monoclonal antibodies in treating certain diseases, rapid growth in this new type of drug ensued. The latest development in biologics is advanced therapy medicinal products (ATMPs).
This presentation delves into the specific supply chain and regulatory compliance challenges, and risks to patient safety, associated with biologics and ATMPs.
His next book for Wiley has the provisional title A Systems-Based Approach to Transforming Pharmaceutical Supply Chains: Transitioning from Patents to Patients, to be published in response to the many questions that have arisen during the C19 enigma.
Sounds like compulsory reading – even MANDATED reading for health regulators around the world!
Hadley Rees’s company website is here:
https://www.pharmaflowltd.com
and his SubStack is here: (100) INSIDE PHARMA | Substack
Onwards!
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I'm half-way through the presentation. It contains very useful information that should convince the most ardent vaccine supporter to think twice before taking another one of these injections. Anyone can understand the dangers arising from poor manufacturing processes - to put it mildly - so I will be sharing this with some family members. Hedley is very relatable and no-one could accuse him of being a so-called conspiracy theorist. Thanks Peter for keeping abreast of such vast amounts of information, saving us a lot of time.