Puresyn is an approved vendor for the production of supercoiled plasmids to be used in the cGMP manufacture of recombinant viral vectors and other products where the supercoiled plasmid is an intermediate in the production of the final product.  As a result, the plasmid does not need to be manufactured under cGMP guidelines for pre-clinical, GLP toxicology or Phase I studies.  However, they should be produced with a cGMP-compatible process.  As a critical raw material or qualified bulk intermediate, the production of these plasmids must have set acceptance specifications and there must be documentation to show that these specifications have been met.  The specifications should be sufficient to ensure that the plasmids perform as expected.  Thus, at a minimum tests should be in place to confirm the identity of the plasmids, a minimum degree of supercoiling and a maximum degree of contamination with process and product related impurities and contaminants such as RNA, genomic DNA, protein and endotoxin.  Also important is the removal of the less biologically active plasmid isoforms, including open circular and linear plasmid.  The expectation is and will remain that records exist on how these vectors were manufactured and that they meet the criteria that would ensure their consistent performance when used to produce viral vectors or other products.

Puresyn meets these requirements through is its “Specials” program.  All components used in the process, from fermentation media through final formulation, are “animal-free” (based on the C of A from each vendor for component products).  All components used in the process, from fermentation flasks, containers, membranes, resin and columns are dedicated to a single plasmid.  There are no shared components and disposables are used when appropriate.  Puresyn contract services are performed under SOP and batch records and reviewed by QA.  All plasmids are provided with a Certificate of Analysis. Puresyn has been audited and certified as an “approved vendor” by some of its customers and plasmids produced at Puresyn have been used to generate recombinant viral vectors under cGMP.