Search results for " impurity"
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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…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
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Considerations in depth filter scale-up
Analysis includes pressure profiles, turbidity and particle reduction, yields, and impurity removal. This data will help process development scientists and engineers understand the structure of these …
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Purification strategies for antibody-derived entities: bispecifics and fragments
Here we present strategies for purifying bispecific antibodies and antibody fragments having the molecule type and the impurity profile in mind.
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Alternative solutions to separate AAV full and empty capsids using anion exchange
Key for a successful process are high overall yields of full capsids with effective empty capsid reduction and efficient impurity removal.
Here we present high-performance anion exchange (AEX) chr…
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Exosome isolation by tangential flow filtration and size exclusion chromatography
We demonstrate a scalable workflow for the isolation of exosomes—a type of extracellular vesicle with significant potential for targeted drug/gene delivery. For research and development and di…
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Selecting Chromatography Resins for Bispecific Antibody Purification
Targeting enhancement with two active antibody arms makes bispecific antibodies (bsAbs) highly attractive for the treatment of cancer and other diseases. Their purification can be more challen…
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Chromatography innovations for the diversified antibody pipeline
Introducing MabSelect™ VH3 affinity resin for antibody variants
At Cytiva, we connect with process developers and manufacturers to understand their needs and strive to make t…
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Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…