Small-molecule API development

RISE designs and optimizes scalable synthetic routes for complex small-molecule APIs and building blocks. Our chemists combine both experience from academia and industry with AI/ML-assisted route scouting, and analytical capability to deliver efficient, robust, and industrially-relevant processes. This includes literature review, route identification, process development and early techno-economic assessment to support strategic decision-making.

We enable scale-up from laboratory to pilot scale through both batch and continuous processes, crystallization and advanced separation technologies. Our facilities accommodate small-volume, high-complexity work as well as pilot-scale production up to approximately 100 liters. Development emphasizes chemical hazard assessment, reproducibility, environmental impact and alignment with future GMP manufacturing and regulatory expectations.

Solid state and crystal form are often critical determinants of stability, processability, and clinical quality. RISE provides solid-state characterization and the design of robust crystallization processes for small-molecule drug substances.

We work with polymorphism, salts, and co-crystals, as well as particle size, morphology, and hygroscopicity. Development is linked early to downstream filtration, drying, formulation, and scale-up to avoid late-stage CMC rework.

Analytical techniques include XRPD (powder and single-crystal), DSC, TGA, DVS, SEM, laser-based particle size analysis, and surface area and porosity measurements.

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Safe development is ensured through systematic evaluation of reaction hazards, byproduct risks and process safety for all chemistries, including HPAPI and high-hazard intermediates. We provide kinetic studies, and detailed safety data to support scalable, compliant and safe manufacturing. Risk mitigation is embedded from early route design through process validation.

Our CMC support spans synthesis route design, impurity profiling, process validation, analytical method development and transfer, crystallization and solid-state studies, techno-economic analysis and scale-up planning. Hazard and safety evaluations are performed for intermediates and HPAPI to ensure safe, reproducible and regulatorily-aligned manufacturing that can transition into GMP production.

RISE provides GMP-compliant pilot and small-scale manufacturing of active pharmaceutical ingredients for preclinical and clinical studies. This includes production of APIs and intermediates with safe handling of HPAPI, analytical method development, validation, in-process monitoring and documentation to support regulatory submissions. Our integrated development-to-manufacturing workflow ensures traceable quality control and efficient progression toward clinical trial delivery.

We utilize process analytical technology (UV-VIS, IR, NIR, RAMAN, FBRM), automated data acquisition systems and real-time monitoring. These tools accelerate optimization, increase reproducibility and facilitate data-driven process control. AI/ML-based route scouting further strengthens decision-making and enhances efficiency in both early development and scale-up.