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Adapting a rapid, accurate testing method for detecting contaminants and impurities is a key step in enabling in-process testing, whether these impurities originate from biopharmaceutical manufacturing processes or from the host cell line. The results from those tests can then be used as part of downstream process characterization to make fact-based, go/no-go forward processing decisions.
The AutoMate Express Nucleic Acid Extraction System is an easy-to-use benchtop instrument that enables hands-free automation of the nucleic acid extraction process for contaminant and impurity testing. The instrument uses the established PrepSEQ nucleic acid extraction chemistry for quantitative recovery of DNA and RNA from diverse sample types, including cell culture, raw material (i.e., serum), and in-process downstream purification samples such as column purification or bulk drug substance (BDS) samples.
Explore this app note to discover a simplified workflow for simultaneous nucleic acid extraction of mycoplasma, MMV, and vesivirus. This approach, using AutoMate Express with PrepSEQ Express, improves speed, accuracy, and contamination monitoring in bioproduction.
Figure 1. DNA recovery from spikes of DNA into various media. Detection of (A) mycoplasma DNA and (B) MMV DNA spiked into PBS (blue), fetal calf serum (black), CHO medium (gray), and conditioned CHO medium (brown). For each matrix, a recovery control (RC) was used to assess extraction efficiency.
Figure 2. DNA recovery from cell culture matrices. Detection of DNA from (A) M. arginini and (B) MMV spiked into PBS (blue), fetal calf serum (black), CHO medium (gray), and CHO conditioned medium (brown). For each plate, control reactions were run with 500, 1,000, and 2,000 copies of the mycoplasma discriminatory positive control or MMV positive control in the real-time PCR assay.
Figure 3. One-hour workflow for the AutoMate Express system.
Explore the Analytics Knowledge Hub and discover a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize analytical testing in your bioprocess workflow.
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For Research Use Only. Not for use in diagnostic procedures.