Plasmid Process Pack 8-8 mL
The New CIM HiP2 Plasmid Process PackTM
pDNA Purification from Lab to Industrial Scale
As the demand for pharmaceutical grade plasmid DNA (pDNA) increases, the developer needs to quickly develop a scalable purification process to meet the demand of the growing gene therapy and vaccine markets. Success of this purification process relies not only on the ability to produce the highest grade pDNA, but also on the ability to decrease the total production cost per mg of pDNA. This can be easily and reproducibly achieved by the use of HiP2 (high performance x high productivity) CIM® Monolithic Columns across all stages from development to production.
The new CIM HiP2 Plasmid Process PackTM for purification of pharmaceutical grade pDNA offers:
• High productivity and performance,
• Low cost per mg of purified pDNA,
• Direct and predictable scalability.
6 mg of pDNA on Lab Scale or 48 mg on Industrial Scale In Less than 3 ½ Hours!
CIM HiP2 Plasmid Process PackTM is available in two sizes, consisting either of 1 mL or 8 mL CIM® Tube Monolithic Columns accompanied with a complete protocol which can even be adjusted to your specific needs. If desired, just individual columns can be purchased. By following complete protocol, CIM HiP2 Plasmid Process PackTM can purify up to 6 mg or 48 mg of pDNA (on 1 mL or 8 mL columns respectively) at more than 80 % pDNA yield and 97 % of sc pDNA. From the time you start with cell harvesting and finish with the buffer exchange only 3 ½ hours are passed - approximately 3 times faster than with other available resins!
Three Times Lower Cost per mg of pDNA
A reduction in number and size of columns needed for chromatographic steps in the purification process has a significant impact on total development and production costs of plasmid DNA. Compounded savings result from lower buffer consumption, decreased labor, and reduced column footprint to generate a highly economical manufacturing process.
CIM HiP2 Plasmid ProcessTM Scheme
The purification process, which does not require RNase treatment, starts with the alkaline lysate, which is adjusted to 0.5 - 1.0 M CaCl2 and, after clarification, loaded onto the CIM® DEAE-1 Tube Monolithic Column. RNA and proteins are separated from the plasmid DNA. DEAE elution fraction is then (after hydrophobic conditions adjustment) further loaded onto the CIM® C4 HLD-1 Tube Monolithic Column. Supercoiled pDNA is then separated from open circular form, genomic DNA and remaining endotoxins. The same results are obtained on CIM® DEAE-8 and CIM® C4 HLD-8 Columns.
The product will be available for orders on our website on the 21st of April.
