Manufacturers rely on Probability of E. coli Breakthrough in Filtration of the toxic soups going into the vile vials. Three mysterious Lots not released? Excipients as sources of Live Bacteria?
The test that is actually missing is the sterility test. In aseptic manufacture, which in the absence of a final product sterilisation by say auroclaving which can't be done (as it would destroy the product) all items used in the manufacture must be sterile and the production process must be done under sterile conditions.
Having a low bioburden before making the final product was only ever to keep the endotoxin levels down.
Smaller pore size filters were being used for virus removal but once you add LNP's to the product the particle size means you will probably lose lots of the product during filtration.
The process to actually manufacture this type of product as a sterile product would require very complicated aseptic/ isolation technology and a lot of time and money as well as specific expertise. If even possible at all. Hardly worth it when what is being injected doesn't do any good and only harm.
The test that is actually missing is the sterility test. In aseptic manufacture, which in the absence of a final product sterilisation by say auroclaving which can't be done (as it would destroy the product) all items used in the manufacture must be sterile and the production process must be done under sterile conditions.
Having a low bioburden before making the final product was only ever to keep the endotoxin levels down.
Smaller pore size filters were being used for virus removal but once you add LNP's to the product the particle size means you will probably lose lots of the product during filtration.
The process to actually manufacture this type of product as a sterile product would require very complicated aseptic/ isolation technology and a lot of time and money as well as specific expertise. If even possible at all. Hardly worth it when what is being injected doesn't do any good and only harm.