Alchemite for Oligonucleotide Manufacturing

Alchemite™ for Oligonucleotide Manufacturing is a machine learning-powered software solution from Intellegens, purpose-built to accelerate process development for oligonucleotide therapeutics. Oligonucleotides are large, complex molecules with demanding synthesis, purification, and analytical requirements, and available manufacturing knowledge is often limited. Alchemite™ addresses these challenges by applying advanced ML across the full manufacturing workflow, helping organisations reduce development timelines and improve manufacturability.

The solution was developed and validated in collaboration with oligonucleotide experts at the Centre for Process Innovation (CPI), with direct input from six leading pharma companies and biotechs, and supported by InnovateUK. Its user interface is specifically tuned to the data upload, analysis, and prediction requirements of oligonucleotide manufacturing, enabling routine process optimisation with less reliance on senior experts while capturing vital knowledge in ML models.

Key Capabilities

• DOE-guided process optimisation: Machine learning-guided design of experiment (DOE) identifies sequence-specific optimal process parameters for Solid Phase Oligonucleotide Synthesis (SPOS), enabling construction of a complete and precise molecular structure during pre-production and recognising complex patterns missed by existing methods.
• Mass spectrometry and chromatography insights: Streamlined data capture and analysis in mass spectrometry workflows with easy upload mechanisms for different chromatography systems. The ML engine provides unique insights including breakdowns of impurity contributions, giving researchers confidence in impurity assignment.
• Impurity reduction: By leveraging the oligonucleotide sequence alongside known impurity and process information, Alchemite™ identifies and proposes routes to minimise critical impurities, resulting in higher product yields, improved productivity, and fewer experiments required during process development.
• Knowledge retention: Vital organisational knowledge is captured within ML models, driving efficiency and innovation across the organisation while retaining corporate memory.

What Is Included in the Solution

• Alchemite™ apps: Straightforward web browser-based access to standard Alchemite™ tools, plus extensions to handle SMILES chemical data and custom oligonucleotide workflows.
• Alchemite™ platform: Cloud-based access to the powerful Alchemite™ machine learning algorithm, enabling background computations at scale.
• Configuration support and ongoing partnership: Intellegens' Science Team supports customers in configuring the system for their specific data, analytical tools, and analysis requirements, and provides ongoing assistance to maximise value from the platform.

Alchemite™ for Oligonucleotide Manufacturing is delivered as an integrated package of software and partner services, accessible via web browser and backed by cloud infrastructure. The solution has been independently validated by CPI for performance, functionality, and usability, making it a trusted choice for pharma and biotech organisations seeking to maximise oligonucleotide development productivity.