{"product_id":"process-characterization-kit-17371770","title":"Process Characterization Kit","description":"\u003cp\u003eThe Process Characterization Kit is a tool for gaining deeper chromatography process understanding. The kit allows you to study the potential impact that resin ligand density might have on the process outcome.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eGet critical insights on resin variation within ligand density specification interval.\u003c\/li\u003e\n\u003cli\u003eDevelop a solid control strategy to obtain a robust, and scalable downstream chromatography process.\u003c\/li\u003e\n\u003cli\u003eConsists of three 25 mL bottles with different ligand densities, representing a low, average, and high value in the manufacturing envelope.\u003c\/li\u003e\n\u003cli\u003eAvailable for multiple resins from the Capto family, supporting the following techniques: ion exchange chromatography (IEX), hydrophobic interaction chromatography (HIC), and multimodal chromatography (MMC).\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eProcess Characterization Kit overview\u003c\/p\u003e\n\n\u003cp\u003e \u003cbr\u003e\nChromatography resins are always produced against a specification interval. The Process Characterization Kit is designed to display this variation.\u003c\/p\u003e\n\n\u003cp\u003eThe kit consists of three bottles with 25 mL of the same resin. Each of the bottles has a different ligand density, representing a low, average, and high value in the manufacturing envelope. In most cases the levels will be similar to the specification window (Fig 1).\u003c\/p\u003e\n\n\u003cp\u003eFor ion exchange resins, ligand density is measured as ion capacity. For hydrophobic interaction resins, it is measured as retention time for a model protein.\u003c\/p\u003e\n\n\u003cp\u003e\u003cimg class=\"img-responsive center-block\" src=\"https:\/\/cdn.cytivalifesciences.com\/dmm3bwsv3\/AssetStream.aspx?mediaformatid=10061\u0026amp;destinationid=10016\u0026amp;assetid=32075\" style=\"width: 500px;\"\u003e\u003c\/p\u003e\n\n\u003cp class=\"-font--minus-2\"\u003e\u003cstrong\u003eFig 1.\u003c\/strong\u003e The target ligand densities in a Process Characterization Kit printed over the manufacturing envelope.\u003c\/p\u003e\n\n\u003cp\u003eResins available in the Process Characterization Kit format\u003c\/p\u003e\n\n\u003cp\u003e \u003cbr\u003e\nCation exchange chromatography resins:\u003c\/p\u003e\n\n\u003cul\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/ion-exchange\/capto-s-impact-ion-exchange-chromatography-resin-p-00669\"\u003eCapto S ImpAct\u003c\/a\u003e\u003c\/li\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/prepacked-columns\/ion-exchange\/capto-sp-impres-ion-exchange-chromatography-resin-p-00695\"\u003eCapto SP ImpRes\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eMultimodal chromatography resins:\u003c\/p\u003e\n\n\u003cul\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/multimodal\/capto-mmc-multimodal-chromatography-resin-p-05538\"\u003eCapto MMC\u003c\/a\u003e\u003c\/li\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/multimodal\/capto-mmc-impres-multimodal-chromatography-resin-p-05539\"\u003eCapto MMC ImpRes\u003c\/a\u003e\u003c\/li\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/multimodal\/capto-adhere-multimodal-chromatography-resin-p-05643\"\u003eCapto adhere\u003c\/a\u003e\u003c\/li\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/multimodal\/capto-adhere-impres-multimodal-chromatography-resin-p-06142\"\u003eCapto adhere ImpRes\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eHydrophobic interaction chromatography resins:\u003c\/p\u003e\n\n\u003cul\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/hydrophobic-interaction\/capto-phenyl-high-sub-hydrophobic-interaction-chromatography-resin-p-05571\"\u003eCapto Phenyl (high sub)\u003c\/a\u003e\u003c\/li\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/hydrophobic-interaction\/capto-phenyl-impres-hydrophobic-interaction-chromatography-resin-p-06292\"\u003eCapto Phenyl ImpRes\u003c\/a\u003e\u003c\/li\u003e\n\t\u003cli\u003e\u003ca href=\"\/shop\/chromatography\/resins\/hydrophobic-interaction\/capto-butyl-impres-hydrophobic-interaction-chromatography-resin-p-05678\"\u003eCapto Butyl ImpRes\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe growing need for deeper process understanding\u003c\/p\u003e\n\n\u003cp\u003e \u003cbr\u003e\nWith the increased molecular diversity and drive for higher productivity, the challenge of getting deeper understanding for sources of variability and set mitigation strategies grows.\u003c\/p\u003e\n\n\u003cp\u003eOver the past decade, using a quality by design (QbD) approach to biopharmaceutical process development has helped ensure patient safety and drug efficacy. QbD incorporates the identification of critical quality attributes (CQAs) and links to critical process parameters (CPPs) and critical material attributes (CMAs).\u003c\/p\u003e\n\n\u003cp\u003eChromatography resin properties are sometimes suggested as CMAs that potentially could impact CQAs. The properties are also considered important parameters for consistent downstream chromatography process performance.\u003c\/p\u003e\n\n\u003cp\u003eA chromatography resin is made of a base matrix (porous particle) with a specific ligand added at a desired concentration to achieve its intended function. Studying the potential impact of ligand density variability provides invaluable information for developing strategies to ensure robust process performance.\u003c\/p\u003e\n\n\u003cp\u003e\u003ca href=\"\/solutions\/bioprocessing\/products-and-solutions\/accelerate-biopharmaceutical-process-development\/Process-characterization\"\u003eAccess insights and recommendations for developing robust purification processes for biopharmaceuticals.\u003c\/a\u003e\u003c\/p\u003e\n\u003ch2\u003eDocuments\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"https:\/\/cdn.cytivalifesciences.com\/api\/public\/content\/digi-14385-pdf\"\u003eData file (PDF)\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"https:\/\/cdn.cytivalifesciences.com\/api\/public\/content\/digi-29872-pdf\"\u003eInstructions for use (PDF)\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Cytiva","offers":[{"title":"Cation exchange \/ 3 × 25 mL (17371770)","offer_id":45982182965327,"sku":"17371770","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Cation exchange \/ 3 × 25 mL (17546870)","offer_id":45982182998095,"sku":"17546870","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Hydrophobic interaction \/ 3 × 25 mL (17548470)","offer_id":45982183030863,"sku":"17548470","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Hydrophobic interaction \/ 3 × 25 mL (17371970)","offer_id":45982183063631,"sku":"17371970","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Hydrophobic interaction \/ 3 × 25 mL (17545170)","offer_id":45982183096399,"sku":"17545170","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Multimodal \/ 3 × 25 mL (17531770)","offer_id":45982183129167,"sku":"17531770","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Multimodal \/ 3 × 25 mL (17544470)","offer_id":45982183161935,"sku":"17544470","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Multimodal \/ 3 × 25 mL (17371670)","offer_id":45982183194703,"sku":"17371670","price":0.0,"currency_code":"ILS","in_stock":true},{"title":"Multimodal \/ 3 × 25 mL (17371570)","offer_id":45982183227471,"sku":"17371570","price":0.0,"currency_code":"ILS","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0712\/0748\/5519\/files\/digi-32066-original-png_e3ab0cc8-149d-4c0d-bd23-cbdf7ed6536f.png?v=1785958934","url":"https:\/\/www.danyel.co.il\/products\/process-characterization-kit-17371770","provider":"danyel biotech","version":"1.0","type":"link"}