Enabling in-process control with analytical monitoring after each cycle

Robust in-process control (IPC) testing is critical to achieving consistent product quality and purity in oligonucleotide manufacturing. Conventional solid-phase oligonucleotide synthesis (SPOS) presents IPC testing limitations due to the closed reaction environment and resin-bound intermediates. SPOS is susceptible to a range of failure modes that can result in unintended sequence modifications and/or isobaric impurities. These limitations demonstrate a need for identity testing strategies that go beyond traditional de novo sequencing that rely on intact mass measurement combined with a sequence-sensitive secondary testing to confirm oligonucleotide identity post manufacture. 

ECO Synthesis is a solution-phase enzymatic siRNA manufacturing platform that enables sampling and analytical testing of intermediates at each extension and deblock step via LC-MS. This stepwise monitoring strategy allows for

✅ Real-time synthesis fidelity checks
✅ Early detection of process deviations
✅ Opportunities for closed-loop parameter adjustments

Resulting in a highly controlled and efficient pathway for oligonucleotide cGMP production through early detection of product modifications resulting in high standards of API product quality, ensuring patient safety.