As COVID-19 testing volumes expanded worldwide, maintaining consistency, throughput, and analytical confidence in oligonucleotide production became increasingly complex. Where Part 1 discussed assay design, synthesis scalability, and analytical validation considerations, this second white paper explores the downstream challenges associated with large-scale primer and probe manufacture, including purification, quality assessment, and batch-to-batch reproducibility. Key topics addressed include:
- Scalable analytical workflow strategies
- Large-scale primer and probe manufacture
- Purification workflows for oligonucleotides
- Quality assessment and reproducibility
- Reducing production bottlenecks
Part 2 highlights process optimizations and quality-assurance strategies implemented to sustain high output without compromising performance. Together, these approaches illustrate how scalable analytical workflows and rigorous quality control are essential for supporting reliable diagnostic testing throughout prolonged public-health crises.