Investigation of a failed DNA assay leads to identification of an unexpected contaminant in a commonly used chromatography buffer
Author:
Affiliation:
1. Attribute Sciences, Process Development, Drug Substance Technologies, Process Development Quality Administration, Quality, Amgen Inc. Thousand Oaks California USA
Publisher
Wiley
Subject
Biotechnology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/btpr.3307
Reference23 articles.
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3. WHO Requirements for the Use of Animal Cells asin vitroSubstrates for the Production of Biologicals (Requirements for Biological Susbstances No. 50)
4. Development and Validation of Quantitative Real-Time PCR for the Detection of Residual CHO Host Cell DNA and Optimization of Sample Pretreatment Method in Biopharmaceutical Products
5. Specific detection of residual CHO host cell DNA by real-time PCR
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