Search results for " scientists"
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Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
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Critical Quality Attributes Challenge Biologics Development
… Committee member and past-chair of the BIOTEC Section at the American Association of Pharmaceutical Scientists (AAPS), about how CQAs for biologics differ from CQAs for small-molecule drugs and how …
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High Throughput Protein Purification at a Glance
Within the Human Protein Atlas project, scientists are using ÄKTA systems to purify up to 180 protein samples per week. The project uses antibodies to study the localization of proteins in huma…
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Reconciling Sensor Communication Gaps
Hence, process scientists desire real-time measurements. Moreover, total cell measurements are most reliable only during the cells’ log phase, when they are expanding.cleaning validation, and calibrat…
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Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
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Process Chromatography Selection for Downstream Processing Applications
Industry experts discuss best practices for selecting a separation technology.
By Caroline Hroncich
Process chromatography has changed significantly since it was first introduced to the biop…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
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Principles and methods for automated multistep protein purification
Principles of Automated Multistep Protein Purification
Summarized questions related to principles of multistep processing and the case study presented by Erwin van Puijenbroek and Matthias H…
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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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Innovative Therapies Require Modern Manufacturing Systems
Manufacturing concerns
These developments generate optimism that scientists finally will begin to transform the treatment of disease based on decades of important genomic research. FDA’s Center fo…