Novel Real Time Polymerase Chain Reaction Approach for Rapid Detection of the Residual Escherichia coli Genomic DNA in Biopharmaceutical Products Establishment of Real Time Polymerase Chain Reaction to Detect Residual gDNA
Abstract:Background: Contamination of therapeutic recombinant proteins with residual host cell DNA must be controlled under the regulatory standards. Objectives: The current study established a new rapid, sensitive real time polymerase chain reaction (PCR) approach to measure the reliably of the residual Escherichia coli (E. coli) host cell genomic DNA in the recombinant streptokinase and alfa interferon preparations. Materials and Methods: In this assay, a specific primer pair was utilized to amplify a 115 base pair s… Show more
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