Within the Eurpean Union, however, the increasing trend seems to be that such plasmids should be produced under CGMPs from master cell banks and to the same standards and product-release specifications as are conventional plasmid products for therapeutic applications. Although the production of plasmids as therapeutic agents has always been performed to current good manufacturing practices (CGMPs), the regulations relating to their production for viral constructs has been under some debate. Those used for viral constructs are larger (≥11 kb). Plasmids used for therapeutic agents tend to be relatively small - usually 4.5–6 kb - but can be as small as 2.5 kb. Plasmid DNA is used in clinical trials two ways: as a therapeutic agent (either as a therapy or for the generation of vaccine antigens) and as a transfection agent to produce viral constructs such as lentivirus or adenoassociated virus (AAV), for which multiple plasmid constructs are required to produce an individual viral product in transient production systems. The resin had reported binding capacities in the region of 2mg/mL, which is relatively high for a large macromolecule. Separation was achieved using isocratic (as well as gradient) elution from the column, which is more easily scaled and may have better resolution and processing yields. PlasmidSelect Xtra resin is based on thiophilic aromatic chromatography, which can separate plasmid from host contaminants (e.g., chromosomal DNA and endotoxin) and provides good resolution between open- and closed-circle forms of plasmid DNA ( 2, 3). economical (low cost of goods basis at manufacturing scale).modifiable with minimal changes to existing recovery and capture steps.
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