THE BIOPHARMACEUTICAL (INCLUDES VACCINES) SUPPLY CHAIN

Nailing the fundamentals

WHAT ARE BIOLOGIC MEDICINES?

There are two main types of medicines produced in the pharmaceutical industry:

• Small molecule - that means they are made using industrial chemistry. Aspirin is an example. The pharmaceutical industry was mainly founded on small molecule products.

• Biologics (large molecule) - essentially made from living things, such as animal and human cells. A monoclonal antibody is an example. There has been rapid growth of biologics in recent years.

The SARS-CoV-2 injection is classed as a biologic.

WHAT ARE THE SUPPLY CHAIN CHALLENGES?

It is an order of magnitude more difficult building and managing a biologics supply chain, than for a small molecule product.

Firstly, biologics are very sensitive to changes in temperature, as you might imagine, as they are living things.

As early as 1919, this unique challenge was identified by Parke, Davies & Co (latterly to become Pfizer):

“Biological products are essentially perishable because they consist of organic matter and are therefore influenced by extremes of temperature and the actinic effect of light.

Carelessness in the handling and storage of smallpox vaccine, for example, often results in such injury to the product that it becomes inert, although physically it may appear to be in perfect condition and is of recent manufacture.

Smallpox vaccine should be stored in a refrigerator or someplace where the temperature does not exceed 50°F.” (Parke, Davis & Co. 1919)” (2011 Sourcebook, Healthcare Commerce Media Corp. P.19’).

This is one of the red flags associated with biologics—they may look fine, but they may be useless, or even adulterated in some way that would not be readily visible.

Next, small molecule products can be reproduced reasonably accurately, and specified, independent of the facility and equipment used to make it.

With biologics, the molecules are so large and complex that it is often impossible to specify their molecular structures by analysis. All that is known is that a particular process has produced something that has a particular biological effect on a patient. Other manufacturers may not be able to replicate that product and its effect, even if the process appears to be exactly the same.

This is described in the industry by the mantra “the process is the product.”

This red flag is the reason why copies of small molecule products (generics) have been successful in driving down prices of medicines, whereas biologics copies (biosimilars) are very slow to gain traction.

Input materials can also be problematic also. They can dramatically affect yield, potency, and quality of output, as the strength (titre) of each new supply of materials can vary widely, depending on factors that are not always obvious to the acquiring company.

Getting good pedigree information from suppliers, especially when the upstream supply chain leads to seemingly anonymous donors, can be a nightmare and sometimes even impossible.

The net result of all the factors is that biologics are extremely tricky to develop, supply, maintain safe, and produce cost-effectively than a small molecule product.

NOT A LOT OF PEOPLE KNOW THIS

Hopefully, you have found this helpful. Armed with this knowledge, medical freedom fighters would have been able to ask more searching questions about the SARS-CoV-2 injections in relation to how these challenges were surmounted, apparently, with consummate ease!

That’s it for now.

Hedley