Most of these materials are available both in pre-packed columns and, in some cases, as loose resins. GE’s high-flow agarose products are all named by some variant on the trade name “Capto™,” for example Capto SP/Q ImpRes or Capto S/Q HiRes ion exchange resins. GE has historically relied on agarose as a base resin material, and has further refined this material for the high flows and relatively low pressures required at prep scales. Many purification resins, including ion exchangers, are based on agarose beads. Among these, pressure is arguably the most significant. The physical conditions that chromatography resins experience during purification is a key factor in resin selection. Even in instances where the standard HPLC analytical method uses reverse phase separation, ion exchange may be preferable at preparative or even manufacturing scale. Here, it resolves capsids that are empty versus those containing the therapeutic gene. Preparative ion exchange also works well for viral vectors, which are essential components for both cell and gene therapies. “The emergence of novel antibodies and therapeutic proteins, for example bispecific or trispecific antibodies and antibody fragments, makes ion exchange-including mixed-mode resins-even more attractive.” Peter Hagwall, who manages process development and characterization products for GE Healthcare (Uppsala, Sweden). It resolves both process-related impurities such as host cell proteins, and product-related impurities such as charge variants, with scalability and under mild conditions,” says Dr. “Ion exchange lends itself well to purification of many classes of therapeutic proteins. Whether these applications employ one of the separation modes mentioned above, or specifically ion exchange, depends on the molecule and circumstances. These products in turn have facilitated drug discovery and academic research that relied on purifying proteins and peptides from their often-complex matrices. This has given rise to resins and columns applicable to process development and, via scale-down and high throughput experiments, process optimization and troubleshooting. Over the last 30 years, the purification of therapeutic molecules, especially proteins at manufacturing scale, has driven many of the advances in preparative chromatography. flash chromatography), reverse phase, affinity, size exclusion, HILIC (hydrophilic interaction chromatography), IMAC (immobilized metal affinity chromatography), and both cation and anion exchange. Preparative-grade resins and pre-packed columns are now available for most separation modes, including normal phase (e.g. Preparative chromatography-the non-analytical chromatographic purification of milligrams to kilograms of product-has found applications in many industries and for a diverse set of molecules.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |