
Many new gene therapies and medicines use viral vectors such as AAV's, lentivirus and adenovirus as their delivery method. These viral vectors require extensive purification efforts to remove cellular debris from the crude staring media, concentrate the results and removal of empty capsids. Current techniques require multiple process steps and are difficult to scale.
LNPs are increasingly becoming the vector of choice for delivering drug payloads such as mRNA, CRISPR-Cas9, plasmid DNA and small molecule drugs. Typically, these LNPs need to be in a narrow size range for delivery optimization, so post processing to separate by size is critical. Additionally, encapsulation efficiency is generally low, and it is desirable to separate loaded LNPs from unloaded ones as further purification and dose control.
Extracellular Vesicles (EVs) represent an exploding area of development for diagnostics, therapeutics and as drug delivery vectors. EVs are naturally occurring lipid-bound nanoparticles found in diverse sources such as blood, urine, cerebrospinal fluid (CSF), breast milk and saliva. These source materials are complex and full of other particulates besides the EVs. An enormous amount of effort is being applied to finding better ways to isolate and purify the EVs from the source material.
Synthetically produced nanoparticles, such as gold nanoparticles, magnetic nanoparticles, dendrimers and liposomes are also being heavily studied and used for many applications. Insuring consistent, narrow size distributions is a critical quality attribute (CQA) of almost all nanoparticles, so the ability to separate by size and remove impurities from the manufacturing process is essential.
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