Search results for " impurities" in Articles / App Notes
Article
Enhancing Resins Addresses Purification Concerns
In addition, critical impurities, such as open circular pDNA, genomic DNA and high molecular weight RNA have similar properties making the separation of these impurities more difficult (3),” he says. …
Article
Transformative Medicines Challenge FDA and Manufacturers
Presentations covered the importance of control strategies and the need to characterize and qualify impurities, including the use of platform data in assessing oligo impurities.
Firoz Antia, d…
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SEC in the Modern Downstream Purification Process
Prior to a final polishing step, the intermediate puriï¬cation steps are designed to remove most of the process-related impurities, such as host-cell proteins, endotoxins, nucleic acids, and viruses…
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Challenges of Protein Aggregation During Purification
…harges, sizes, hydrophobicities, and other physiochemical properties of the therapeutic molecule and impurities, including aggregates. Different combinations of unit operations may be used to recover…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
It is through this effort that the quality and regulatory aspects of the new drug are defined such as the type of dosage form, the target dose, the in-vivo drug availability, and limit of impurities. …
Article
QbD and PAT in Upstream and Downstream Processing
These would be product-quality related parameters, including host-cell impurities (e.g., host-cell proteins, DNA), process-related (e.g., Protein A leachate), and product related (e.g., aggregate, bas…
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Trace metals getting you down? Learn what’s really in your cell culture media
Heavy metal impurities in your media can have a drastic effect on cell viability, with some impurities reducing cell culture density by as much as 17x. So, how can you be sure these impurities are con…
Article
Gene Therapies Push Viral Vector Production
In addition, it is important to maintain AAV vector biological activity when removing impurities and contaminates present in a feedstock that originates from host cells or culture media. Next to this,…
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A Look at the Affinity Chromatography Landscape
Beyond impurity removal for “simple” proteins
Affinity chromatography in biologics manufacturing has typically served as a method for removal of process-related impurities such as host-cell protei…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
If not removed by the purification process, these unintended byproducts are typically considered product-related impurities (PRI), as defined by International Council for Harmonisation of Technical Re…