Technical Paper
The Alchemite™ for Oligonucleotide Manufacturing solution was created through a two-year collaborative project to create software customized for oligonucleotide manufacturing data, applying the power of machine learning to remove critical bottlenecks in process development. This Technical Paper provides background and details of validation work.
Executive Summary
Therapeutic oligonucleotides are scaling from discovery to commercial supply, but variability and impurities introduced during solid-phase oligonucleotide synthesis (SPOS) remain a significant barrier to robust, economic manufacturing. When impurities emerge early, downstream cleavage and deprotection (C&D), purification, and analytics become slower and costlier. Intellegens and CPI, funded by Innovate UK, have developed a novel software solution to this problem. Alchemite™ for Oligonucleotide Manufacturing leverages the proven capabilities of the Alchemite™ machine learning (ML) method to train ML models that uncover complex relationships linking production processes and product quality. These models enable accurate performance prediction and development of optimized quality control strategies. By interpreting both structural information of oligonucleotides and key processing parameters, Alchemite™ delivers a comprehensive, system-level view enabling efficient and informed process development. This paper introduces the Alchemite™ solution and reports the results of validation work conducted at CPI. Results include:
- Improved product yields by reducing critical impurities.
- Increased productivity through automated review of process data and identification of impurities.
- A reduction in the number of experiments required to achieve goals.
- Support for sustainability goals, minimizing waste.
- Knowledge capture and sharing to develop and retain corporate memory.
