Search results for " impurity"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
While building a knowledge base on residual impurities requires investment, that investment pays off in the long term because it enables risk-based residual impurity control and minimizes the need for…
Article
Impurity Testing of Biologic Drug Products
“On the other hand, the impurity may exaggerate or enhance the therapeutic protein’s bioactivity in an uncontrolled way, leading to adverse events. Some impurities (especially host cell proteins) may …
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Managing Residual Impurities During Downstream Processing
A few words about host-cell DNA
Similar to HCPs, given the route of manufacture of biologics, residual host-cell DNA is another potential impurity that requires close control. Proposed USP chapter …
Article
Preclinical Evaluation of Product Related Impurities and Variants
From the processing perspective, while clearance of aggregates and the reduced GCSF impurity are quite achievable in most commercial processes, adequate clearance of the oxidized and f-Met GCSF is a c…
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Capture of Bispecific Antibodies and Removal of Product-Related Impurities
The biotherapeutics pipeline is becoming increasingly diverse as antibody variants such as bispecifics, conjugates, and fragments move through preclinical stages to commercial manufacturin…
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Paring Down Impurities in Downstream Processing
Myriad choices confront manufacturers before they even consider optimizing downstream processes. Each decision directly influences what final options will be available on arriving at the final…
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Using Quality by Design to Develop Robust Chromatographic Methods
The accuracy and precision of the procedure must be such that the measurements fall within ±15% of the true value for impurity levels ≤ 0.15% with at least 90% probability and within ±10% of the true …
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Quality by design for biotechnology products—part 1
The scope of this paper is limited to well-characterized protein products, in which the natural molecular heterogeneity, impurity profile, and potency can be defined with a high degree of confidence. …
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Evolution of the Monoclonal Antibody Purification Platform
During development of therapeutic candidates expressed in dhfr- CHO, for example, an impurity that was later identified as the mAb with unprocessed heavy chain leader sequence was insufficiently clear…
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What’s in your media? How costly is variability of cell culture media to your manufacturing process?
We noticed that when we compare from different vendors or the same vendors there is inherent variation in the trace impurity profiles. Once we see this variation, we go back to the source which the va…