By Uwe Gottschalk
Conventional column chromatography dominates present purification know-how, and plenty of of the productiveness profits which were completed have trusted upscaling such units. besides the fact that, this comes with a price penalty and the pharmaceutical has reached the purpose at which additional upscaling turns into economically unsupportable. This publication bargains a broad-based reassessment of outdated and new purification tools, incorporating an research of cutting edge new developments in purification. The publication has large insurance of other antibody purification suggestions and brings jointly top-tier specialists to handle difficulties in process-scale antibody purification.
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Additional info for Process scale purification of antibodies
Sample text
Reusable virus filters could also significantly affect COGs. For a process with a nonfouling feedstream and a control strategy using consistent process flux decay and clean water flux restoration as important process parameters, combined with a validated post-use integrity test, companies may consider developing validation packages that support virus filter reuse. Technology to inactive viruses (heat or ultraviolet irradiation) that could potentially substitute for VF or pH inactivation would entail capital costs for new equipment, and could result in scale-up issues.
Although the practical limit to Protein A resin capacity may fall short of 100 g/L, product capture using ion-exchange resins could offer even higher capacities, albeit probably at the expense of general applicability and streamlined development of Protein A chromatography for product capture. There would be a great advantage in the development of high-flux, highcapacity parvovirus filters, which would significantly decrease COGs and increase productivity. Reusable virus filters could also significantly affect COGs.
Such a design space is the basis for consistent, reproducible manufacturing operations, but also allows changes within the design space over the product’s life cycle in response to changing conditions. 8 FUTURE OPPORTUNITIES With standard mAb purification platform processes firmly entrenched in the industry and representing the current state of the art, one might ask what the future will hold. Several opportunities addressing this question will be presented in this section. Some of these suppositions may come to pass, while others may never be adopted.