Bioradiations Staff
In June, Bio-Rad hosted Droplet Digital PCR (ddPCR) World 2024, the premier digital PCR event bringing together global leaders in science and innovation. ddPCR World features top experts showcasing how ddPCR technology has been instrumental in overcoming some of their most complex research and manufacturing challenges. From advancing molecular diagnostics to streamlining drug development, ddPCR World 2024 featured 12 renowned researchers spanning the Americas and Europe. In this article, we are excited to share key insights and cutting-edge research using ddPCR technology that are driving scientific breakthroughs across the globe.
Biopharma Manufacturing
During therapeutic product development, manufacturers must demonstrate product quality and ensure that process contaminants do not exceed levels established by regulatory agencies.
Approaches discussed during ddPCR World include the development of high-performing ddPCR assays for the detection of potentially harmful contaminants, replication competent retroviruses (RCR), and the characterization of adeno-associated virus (AAV) vectors, ensuring product safety throughout the manufacturing process. In the early phases of manufacturing, ddPCR technology was also used to genetically characterize clones generated throughout cell line development processes for the selection of the most suitable clones for scale-up and biologic drug production. Presentations that focused on these themes include:
- Testing for Replication-Competent Retroviruses (RCR) in Cell Therapy Drug Products (DP) using Droplet Digital PCR — Angel E Flores, PhD, Molecular Assay Development, Cell Therapies, Takeda Pharmaceutical Company Ltd.
- ddPCR to Characterize Production Clones in Early Phases of Biomanufacturing — Katia Cantalupo, Molecular Biology Technologies & Innovation, Healthcare Division, Merck
- Droplet Digital PCR for Optimized Product Characterization During rAAV Manufacturing Process — Nerea Galdona, Biomolecular Development, Viralgen
Oncology Research
Disease markers, such as circulating tumor DNA (ctDNA), are often present at very low abundance in liquid biopsies, particularly in the case of solid tumors. ddPCR technology provides outstanding sensitivity and precision in biomarker monitoring, providing an alternative approach for early cancer detection and post-treatment minimal residual disease (MRD) monitoring. Highlighting these capabilities, the following presentations demonstrated the practical utility of ddPCR technology in monitoring MRD and provided insights on using these methodologies:
- Clinical Utility of Circulating Tumour DNA to Guide Treatment in Early Breast Cancer Patients — Isaac Garcia-Murillas, The Institute of Cancer Research, London
- Droplet Digital PCR: ctDNA Detection Through Promotor-Hypermethylation — Anna Ennemoser, Medical University of Innsbruck
- Droplet Digital PCR (ddPCR) in Oncology Clinical Validation and Research – A Single Institutional Experience — Dragana Milosevic, Department of Laboratory Medicine and Pathology, Mayo Clinic
- Novel ddPCR-Based Technological Platform for Early Cancer Detection — Clara Garcia Samartino, Epiliquid
Cell and Gene Therapy
Within the field of cell and gene therapy, CAR T-cell therapies have revolutionized cancer treatment but require stringent quality control measures to determine therapeutic efficacy and safety. Demonstrating product safety includes the precise measurement of vector copy number (VCN), which influences the risk for insertional mutagenesis. David Cobeta Lopez presented that ddPCR technology facilitated accurate determination of VCN in CAR T-cell therapy manufacturing, optimizing product quality.
- CAR T-Cell Safety Concerns and Vector Copy Number Determination by ddPCR — David Cobeta Lopez, Charles River Laboratories
Advanced Applications of ddPCR Technology
Offering a flexible solution for absolute quantification across a range of therapeutic areas, ddPCR technology provides researchers with the capacity to develop and validate target-specific assays for more advanced or custom applications. The following presentations discussed the detection of microsatellite instability (MSI) in colorectal cancer and the use of empty/full capsid ddPCR technology assays to determine capsid titer and the proportion of properly packaged viruses in a viral batch:
- A Novel ddPCR‑Based MSI Test for Colorectal Cancer Patient Assessment — Valerie Taly, Translational Research and Microfluidics Cordeliers Research Center
- Empty/Full rAAV Capsid Characterization: Quantifying Viral Genome and Capsid Titers in a Single ddPCR Reaction — Tyler Lindgren, BridgeBio Inc.
Wastewater-Based Epidemiology
The ddPCR World 2024 presentations also showcased some of the latest updates in wastewater monitoring for the detection and quantification of pathogenic markers in support of community health programs. The following presentations explored how ddPCR assays are designed and used to detect pathogens in wastewater. These strategies for improved pathogen detection result in better data on the number of infections in a population compared to reported case numbers, which ultimately supports accurate indirect monitoring of population infection rates.
- Development of an Assay for Respiratory Pathogens on the QX600 for Wastewater-based Epidemiology – Kyle McElroy, Biobot Analytics, Inc.
- Using ddPCR to Detect Emerging and Endemic Pathogens in Wastewater – Bradley White, Verily Life Sciences LLC
To learn more about the diverse applications of ddPCR technology in oncology, cell and gene therapy manufacturing, and wastewater monitoring, register now to watch the presentations on-demand and unlock the full potential of ddPCR technology.