Cholesterol is a derivative of cyclopentane polyhydrophenanthrene, widely present in animals. It participates in the formation of cell membranes and is an essential substance in animal tissue cells. Traditional sources of cholesterol are all animal-derived, mainly obtained by saponifying the brains and spinal tendons of pigs, cows, and sheep, or from lanolin, and then extracted using organic solvents. However, since many diseases have been found to be transmitted from animals to humans, according to the latest guidelines for cell and gene therapies, the use of animal-derived components should be avoided, necessitating a safer source of cholesterol——Cholesterol (Plant Derived).
According to process research, through the exploration and optimization of key process parameters, a stable plasmid mass production process was determined. The production process should include clear production scale, process flow, detailed description of process steps, and process control strategies. Human and animal-derived materials should be avoided as much as possible in plasmid production, and the use of β-lactam antibiotics should be avoided. If other types of antibiotics are used, their residue levels should be controlled and safety evaluated. Based on the development stage and risk assessment, plasmid process validation or confirmation studies should be conducted, such as process control confirmation, intermediate product storage stability studies, multi-batch quality analysis, and impurity removal studies.
Pharmaceutical excipients are closely related to drugs. In 2008, the "heparin" incident in the United States; in 2010, the detection of porcine circovirus DNA in oral rotavirus vaccines; in 2012, the "chromium-exceeding capsule incident" exposed by CCTV's "Weekly Quality Report"; and in 2015, the investigation of the illegal production of deproteinized calf blood extract injection by Chinese drug regulatory authorities made us deeply remember the safety incidents of drugs produced with animal-derived excipients and raw materials. The European Medicines Agency also issued guidelines on reducing the risk of transmissible spongiform encephalopathy, which has greatly increased the interest of major pharmaceutical and biopharmaceutical companies in plant-derived excipients.
Currently, simply identifying the final products of animal-derived pharmaceutical excipients cannot achieve good quality control. With the improvement of economic and scientific research capabilities, the upgrading of consumer consumption, and the continuous enhancement of public health awareness, more and more pharmaceutical excipients are emerging, such as Cholesterol (Plant Derived), cellulose capsules, alginate capsules, and others. These non-animal-derived pharmaceutical excipients are becoming another consumer choice due to their natural purity, lack of pollution, absence of animal-derived pathogens, no genetic risk, and effective avoidance of the risks associated with excessive heavy metal chromium and carcinogenic chemical residues.
AVT supplies Cholesterol (Plant Derived) products to the market with no genetic risk, eliminating concerns about animal-derived cholesterol carrying animal viruses, meeting production demands. It can be used in the following scenarios: preparation of lipid nanoparticles (LNP) delivery systems, traditional liposome encapsulation of small molecule drugs, serum-free cell culture of protein drugs, advanced pharmaceutical research, and the key synthetic raw materials for vitamin D and its derivatives.
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