Search results for " Downstream PD"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
This week we speak with Konstantin Konstantinov, Genzyme Vice-President Late Stage Process Development, about developments in continuous processing.
Q: You’re part of an upcoming sym…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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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 …
Article
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…