Oligonucleotide-based drugs continue to flow into developmental pipelines, and the relatively large numbers now being tested in humans and progressing through late-stage clinical studies have buoyed optimism that commercialization of oligo therapeutics may finally come sooner rather than later. In parallel to these advances is a high level of confidence in the industry's ability to produce GMP oligos at large scale reliably, reproducibly, and cost effectively, and to meet the analytical and process-validation strategies needed to satisfy evolving regulatory requirements.
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