Search results for " Biopharm" in Articles / App Notes
Article
Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
Next Steps
As cell culture titers continue to increase, the biopharmaceuticals industry will be faced with new challenges, including greater product heterogeneity and increasing impurity levels…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharmaceuticals market. Ever-growing biotechnology pipelines have greatly increased demand for higher throughput, …
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
In a peer-reviewed life cycle assessment (LCA) study, performed by Cytiva in collaboration with Biopharm Services, single-use equipment was compared with conventional stainless steel equipment (3). Th…
Article
Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
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The Future of Biopharma
The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation is driven by pressure for the next new thing, demand for better bioprocessing techn…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…