Search results for " impurities" in Articles / App Notes
Article
Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
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Article
Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Moving PAT from Concept to Reality
…matography coupled with ultraviolet, fluorescence, or MS detectors for evaluation of process-related impurities; and variable pathlength spectroscopy solutions for protein concentration measurement i…
Article
An Analytical Approach to Biosimilar Drug Development
Specifically, these tests are designed to cover the primary, secondary, and higher order of protein structures; the purity and impurities; the post-translational modification, such as glycan profiles;…
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News: Cytiva Adds ELISA Kit to End-to-End HCP Monitoring Capabilities
Cytiva is pleased to announce the new Amersham HCPQuant CHO kit, a generic for detecting host cell protein impurities in drug samples produced in CHO cell lines.
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
Article
The Challenge of Disruptive Technologies in Bioprocessing
…molecules such as ADCs, antibody fragments, and bispecifics are resulting in higher product-specific impurities. Thermo Fisher Scientific aims to address this challenge with a series of commercialize…
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …