Search results for " process"
Article
Cytiva Advances Fiber Chromatography Technology with New Launch
27, 2021, Cytiva announced the launch of HiScreen Fibro PrismA, the newest product available for early monoclonal antibody (mAb) purification process development. The product complements HiTrap Fibro …
Article
Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
With early-stage development programs approaching commercial launch, some organizations are currently relying on manual processes or reactive mitigation strategies.
The iRISK platform is a fully in…
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Cytiva Introduces the Xcellerex Automated Perfusion System
16, 2020 that it is launching the Xcellerex Automated Perfusion System (APS), a device aimed at simplifying processes and reducing risks when intensifying upstream operations.
Integrated with Cyti…
Resource
Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
This makes the pre-packed, small-scale Protein A fiber unit a versatile tool for processes such as clone selection and upstream cell-culture media development. The time savings in downstream processes…
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Risk Assessment: Studying Chromatography Resin Variability
This article focuses on process robustness and the impact of chromatography resin attributes as well as how to identify which parameters and interactions to focus on in your process characterization s…
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Biosimilar Quality Requirements
Factors to consider include the expression system, the manufacturing process, physicochemical properties, functional activities, target binding, impurities, the reference product and reference standar…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
The biopharmaceutical industry faces an increasing demand to accelerate process development while saving on cost and time. A possible solution to alleviate this is by using high-throughput potential t…
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Advances in Engineering of Protein-Based APIs
…efficacy, enabling chronic treatment without liabilities, according to Jennitte Stevens, director of process development at Amgen. Generation of fully human antibodies is achieved in transgenic anima…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
…n the late 1930s and early 1940s, but since that time, substantial improvements in the manufacturing processes have resulted in higher yields, a more diversified product range, and, most importantly,…
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Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Column volume per hour (CV/h) was utilized to enable maintaining residence time throughout the scaling process. The process, performed with MabSelect™ PrismA Protein A chromatography resin, was scaled…