Search results for " impurity" in Articles / App Notes
Article
As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
Depending on the structure of the target antibody and the impurity profile, other affinities, like protein L or variants of protein A, may improve purity and increase removal of impurities.
Cytiva…
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Optimizing capture and polishing steps in an rAAV purification process
The chromatography purification described includes affinity capture to maximize recovery with efficient impurity removal.
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Article
Innovative Chromatography Resins Can Improve Purity and Quality
He concluded that conventional multi-step DSP development bears the increased risk of commercial viability, where yield, impurity levels (such as host cell proteins or product-related impurities) or o…
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Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
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Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the de…
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Addressing the Complex Nature of Downstream Processing with QbD
These steps are typically designed with more specific product attributes in mind and need more fine-tuning to achieve a goal of product or process related impurity or virus reduction,” says MacDonald.…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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Cleaning Protein A Resins with 1 M NaOH
With increasing mAb titers, the impurity level of the cell culture feed increases. If not removed, these impurities can build up on the protein A resin and start to leach into the process material i…
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Reconciling Sensor Communication Gaps
“We need to get past those parameters and start developing sensors that quantify product quality and impurity profiles in a way that is actionable,” Mohindra explains.cleaning validation, and calibrat…