Skip to main content
2025 Summer Scientific Forum Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Pharmaceutical Analysis Track

Recent Developments in Techniques for Pharmaceutical Analysis: Panel Discussion

Wednesday, July 16, 2025
10:50 AM - 11:55 AM ET
Location: Vienna Ballroom: North
Pharmaceutical Analysis Track
The control and monitoring of residual host cell DNA (rDNA) in therapeutic protein production is critical for ensuring the purity and safety of biopharmaceuticals. The conventional method typically involves extensive manual processes starting from DNA extraction to the quantification phase via real-time PCR (qPCR). This often-cumbersome methodology includes meticulous preparation of reagents and plates, which can lead to variability and an increased risk of contamination. In response to these challenges, the study mentioned introduces an automated robotic platform using a compact liquid handler specifically designed for host cell DNA extraction and subsequent plate preparation for qPCR analysis. The comprehensive experiment was conducted to compare automated and manual workflows over a span of three days, incorporating in-process samples from various purification stages. Different parameters like Accuracy, Intermediate precision, Linearity, Range were assessed during the study. The implementation of this automated workflow not only enhances throughput but also improves reproducibility.

Learning Objectives:

  • Attendees will learn the significance of residual DNA in the context of therapeutic protein production, including its potential health risks and the regulatory requirements surrounding its measurement.
  • The presentation will discuss the benefits of robotic liquid handlers in enhancing the efficiency and accuracy of rDNA quantitation workflows, addressing common challenges associated with manual processes.
  • Attendees will be equipped with data demonstrating the performance of automated workflows in rDNA quantitation versus traditional manual methods, enabling them to evaluate potential applications in their own work.