Search results for " assays"
Article
Impurity Testing of Biologic Drug Products
“Other host cell proteins and binding agents carried over from purification columns may mimic the action of the therapeutic protein in assays, leading to mis-formulation of the product outside the the…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Functional analysis
Functional characterization of VLPs includes assays to evaluate binding ability of drug delivery vehicles to specific target cells, or antigenicity and immunogenicity of vaccin…
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Application of Quality by Design to Viral Safety
Once a panel of potential viral contaminants is identified in a raw material, assays such as quantitative polymerase chain reaction (PCR) can be developed for use on a routine basis. Thus, a powerful …
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Preclinical Evaluation of Product Related Impurities and Variants
This is followed by routine analysis using an array of tests (In vitro binding assays, in vitro potency assessment, pharmacokinetics, pharmacodynamics, toxicity assessment). The data from these studie…
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Tackling Analytical Method Development for ADCs
…nd physiochemical properties, including process control methods and release and stability-indicating assays for both the large and small molecule,” says Lisa McDermott, principal scientist at SAFC.
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
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An Analytical Approach to Biosimilar Drug Development
Our early approaches in 2010 used separately validated assays for each analyte. The alternative was to use a single assay, with the biosimilar as the reference standard and the approved product(s) cro…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Biosimilar manufacturers must show that their product performs comparably in analytical and preclinical assays, and must also carry out clinical studies to establish biosimilarity (1, 2).
Monoclon…
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Quality by design for biotechnology products—part 1
…es screening therapeutic protein candidates for immunogenicity using in silico methods, and in vitro assays measuring T-cell responses. Sequence engineering also can be used to eliminate T-cell epito…
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Managing Residual Impurities During Downstream Processing
There is, however, no set of standard assays for the determination of contaminants such as HCPs during manufacturing because each biopharmaceutical process is unique and results in unique impurities; …