Mi is az az ALC lipid (a köz által érthető formában)?
ALC-0315 is the functional cationic lipid component of the drug product. When incorporated in lipid nanoparticles, it helps regulate the endosomal release of the RNA. During drug product manufacturing, introduction of an aqueous RNA solution to an ethanolic lipid mixture containing ALC-0315 at a specific pH leads to an electrostatic interaction between the negatively charged RNA backbone and the positively charged cationic lipid. This electrostatic interaction leads to encapsulation of RNA drug substance resulting with particle formation. Once the lipid nanoparticle is taken up by the cell, the low pH of the endosome renders the LNP fusogenic and allows the release of the RNA into the cytosol.
The primary function of the PEGylated lipid ALC-0159 is to form a protective hydrophilic layer that sterically stabilises the LNP which contributes to storage stability and reduces nonspecific binding to proteins. As higher PEG content can reduce cellular uptake and interaction with the endosomal membrane, PEG content is controlled.
Mit is mond erről a gyártó (nem ér elhinni az egyik kijelentését a másikat meg megtagani):
https://www.echelon-inc.com/statement-on-alc-lipids/
While ALC-0315 and ALC-0159 are being safely used in the BioNTech/Pfizer vaccine, the material that Echelon Biosciences is making and selling is not being used in vaccine production and is only for research use in laboratories. When sold as laboratory products, the manufacturing and testing processes do not need to be as strict as they do when the same product is being administered to people. That is the reason why we state on our website that the material we make is for research use only and not for human use. It is not a statement that ALC-0315 and ALC-0159 are unsafe.
The companies who manufacture ALC-0315, ALC-0159, and other components for the vaccine are following Good Manufacturing Practices (GMP) standards (as required by the FDA) and their facilities are inspected to ensure that their manufacturing processes are controlled and safe for human use.