Småmolekylära läkemedel

RISE supports small molecule developers with tailored solutions across route design, process optimization, solid-state chemistry, analytical characterization, and GMP-compliant production. From early feasibility to clinical trial material, we provide data-driven insights, safe handling of HPAPI, and scalable manufacturing strategies that de-risk development and accelerate timelines

Our services and expertise in drug substance development

Our drug substance services span the full lifecycle of small-molecule API development. We design efficient synthetic routes, optimize and scale processes, perform solid-state and analytical characterization, and manufacture clinical-grade material with safe HPAPI handling. By combining process safety, digital tools, and regulatory-aligned CMC expertise, we deliver development paths that are robust, scalable, and ready for GMP transfer or pilot-scale production.

(Utfällningssektioner)

+ Advanced synthesis & route development

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

+ Process development & scale-up

We enable scale-up from laboratory to pilot scale through both batch and continuous processes, supported by high-pressure and high-temperature chemistry, 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 safety, reproducibility, environmental impact, and alignment with future GMP manufacturing and regulatory expectations.

+ Process safety & chemical hazard management

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, detailed safety data, and QbD-aligned approaches to support scalable, compliant, and safe manufacturing. Risk mitigation is embedded from early route design through process validation.

+ Digital & analytical tools

Our development is supported by 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.

GMP manufacturing of APIs

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.

CMC for drug substance

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 regulatory-aligned manufacturing that can transition into GMP production.

Why RISE

RISE combines decades of academic and industrial expertise in chemistry, chemical engineering, and pharmaceutical process development. Our multidisciplinary team provides tailored, flexible solutions balancing technical performance, safety, sustainability, and regulatory compliance.

How to collaborate

We work with partners at any stage of small molecule development:

• Develop and scale advanced syntheses
• Safely handle HPAPI in laboratory and pilot-scale
• Improve existing processes for efficiency, yield, and safety
• Transition from batch to continuous processes
• Apply PAT and AI/ML tools for process optimization
• Access GMP-compliant production, formulation, and regulatory CMC support

From early discovery to market-ready API, RISE provides reliable, efficient, and sustainable solutions for small molecule drug development.