Search results for " downstream"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…st-in-human (FIH) application, and leveraging a “commercializable” platform for cell culture and downstream process development. At the heart of this strategy is the view that the production cell lin…
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Biopharma in 2015: A Year for Approvals and Innovations
This trend was apparent on PDF, where articles on continuous downstream processing generated a lot of attention.
Single-use technologies still continue to generate interest. In 2015, one could als…
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Best Practices in Qualification of Single-Use Systems
SUS Process Development
Single-use systems are being used in almost all stages of biomanufacturing processes, including upstream, downstream, and fill/finish operations. Figure 1 depicts a typical…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Up until a few years ago, continuous processing was limited to upstream only, because there were no unit operations available for downstream. But now several companies, including Cytiva, are making un…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
The purpose of this assessment is to provide a focus for the downstream process characterization work required to complete process validation Stage 1 (process design).
This initial risk assessm…
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Considerations in depth filter scale-up
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in diffe…
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Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
As you may already know, many biopharmaceutical manufacturers are producing drugs at higher concentrations. This trend is mainly driven by the demand for subcutaneous drugs that are self-admin…
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Explore ÄKTA pilot 600 in 3D
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot™ 600 supports scale-up from process development to GMP clinical scale.
Explore this ÄKTA™ system in…
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Alternative solutions to separate AAV full and empty capsids using anion exchange
Adeno-associated virus (AAV) is the main vector for gene therapy and there is need for scalable, cost-efficient, and robust chromatography-based purification. Key for a successful process are …
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Production of recombinant proteins using a novel affinity technology
This scientific paper from Journal of Chromatography A describes results of a study utilizing a Cytiva Protein Select™ affinity resin and tag platform to produce any recombinant proteins.
Re…