Viruses and other large entities with a molecular mass (M r ) greater than approximately 700 000 (700 kDa) are excluded and are collected in the chromatography flowthrough. Small contaminant molecules enter into the beads where they are captured. The Capto Core 700 medium has a core bead design and consists of an inactive shell and a ligand-activated core. Three alternative process streams for the purification of influenza A/H1N1 were evaluated in this study. In GF, the low productivity relates to low flow rates and limited sample loads. In these processes, both sucrose density gradient ultracentrifugation and GF have limitations in, for example, scalability and productivity. The methods for purification processes have typically involved a combination of sucrose density gradient ultracentrifugation, ultrafiltration/diafiltration (UF/DF) with hollow-fiber membranes, and chromatography using affinity-, ion exchange-, and/or gel filtration (GF) media. However, to meet the needs for pandemic preparedness and scalability of vaccine productions, cell-based processes are being developed and implemented to a greater extent in the industry. Introduction Influenza vaccine has historically and is today primarily produced in embryonated chicken eggs. This study shows that while offering the same purity as gel filtration, Capto Core 700 enables significant improvements in productivity and process economy. Here, the performance of Capto Core 700 in three different processes for the purification of influenza H1N1 virus from infected mammalian cells was evaluated and compared. The size separating mode of operation could be compared to gel filtration (size exclusion chromatography), which is a common approach for polishing steps in vaccine processes. Capto Core 700 is built on the core bead technology which allows for dual functionality combining size separation with binding chromatography. The medium is designed to be used in flowthrough mode for large targets (> M r 700 000) while scavenging smaller contaminants.
Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) Filing date Publication date Priority to US201361799705P priority Critical Application filed by GlaxoSmithKline Biologicals SA filed Critical GlaxoSmithKline Biologicals SA Priority to PCT/EP2014/055014 priority patent/WO2014140211A1/en Publication of EP2970948A1 publication Critical patent/EP2970948A1/en Application granted granted Critical Publication of EP2970948B1 publication Critical patent/EP2970948B1/en Status Active legal-status Critical Current Anticipated expiration legal-status Critical Links Original Assignee GlaxoSmithKline Biologicals SA Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.) ( en Inventor Francesco Berlanda Scorza Yingxia Wen Andrew Geall Frederick PORTER Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.) Active Application number EP14709704.2A Other languages German ( de)
CAPTO CORE 400 PDF
Google Patents Rna purification methodsĭownload PDF Info Publication number EP2970948B1 EP2970948B1 EP14709704.2A EP14709704A EP2970948B1 EP 2970948 B1 EP2970948 B1 EP 2970948B1 EP 14709704 A EP14709704 A EP 14709704A EP 2970948 B1 EP2970948 B1 EP 2970948B1 Authority EP European Patent Office Prior art keywords rna sample buffer purification chromatography Prior art date Legal status (The legal status is an assumption and is not a legal conclusion. Google Patents EP2970948B1 - Rna purification methods
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