Search results for " stability"
Article
Enhancing Resins Addresses Purification Concerns
“Additionally, these HIC and AEX resins are known to foul when used as a capture step, and alkaline stability of resins should be considered, such as resins based on polymethacrylate (e.g., Bakerbond …
Article
Implementing Inline Conditioning to Advance Process Intensification
This required integrating new processes like IC calculations, quality management of real-time buffer release, stock solution stability, and so on. Another challenge was the validation of the inline pr…
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Maximum Output Starts with Optimized Upstream Processing
As a result, a strong and sustainable supply network is more vital to ensure supply chain stability, according to Youngsun Kim, director of the manufacturing science and technology team at Samsung Bio…
Article
Innovative Chromatography Resins Can Improve Purity and Quality
By: Feliza Mirasol
Recent innovations in chromatography resins offer promising advantages in downstream bioprocessing.
With ongoing efforts to increase monoclonal antibody (mAb) productivi…
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Technology Innovations Improve Process Chromatography Performance
Biomanufacturers consider several key factors when selecting a best-fit process chromatography technology for their products, including the stability of the biologic, compatibility of the buffers used…
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Next Generation Process Chromatography
Binding capacities, range of selectivity, and the stability of affinity ligands have been vastly improved. One of the main remaining challenges is that each purification cycle today typically takes >3…
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Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
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- Validation challenges
- Need for greater process control
- Cell line stability problems
- Ability to scale-up process.
Interestingly, while approxi…
Article
Biosimilar Quality Requirements
…t binding, impurities, the reference product and reference standards, the finished drug product, and stability. The document gives details on how comparative analytical assessments should cover these…
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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…