Contact person
Håkan Hollmark
Försäljning-och Marknadschef
Contact Håkan
Drug substance development
Developing small-molecule drug substances requires robust chemistry, scalable processes, and early regulatory alignment. Wrong decisions at this stage often lead to late redesigns, increased costs, and delays before clinical trials.
Taking a drug substance from early discovery to clinical trials is a complex journey with many risks. We help you build the right foundation from the start, with development that is scalable, safe, and aligned with future regulatory requirements. Our support spans the entire early lifecycle – from optimization and scale-up to quality assurance and clinical phase preparation. By combining chemical and process engineering expertise with deep CMC understanding, we create solid decision-making data and a smooth path toward clinical development.
Drug substance development services
Explore our offering or contact us directly for a consultation.
Advanced synthesis and route design
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.
Process development & scale-up
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.
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, and detailed safety data to support scalable, compliant and safe manufacturing. Risk mitigation is embedded from early route design through process validation.
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 regulatorily-aligned manufacturing that can transition into GMP production.
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.
Digital & analytical tools
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.
Why RISE for drug substance development?
RISE combines deep scientific expertise in chemistry and process development with advanced technical infrastructure to deliver integrated, scalable solutions ready for regulatory requirements. We support the entire journey – from route design and process optimization to solid-state characterization and GMP-compliant API manufacturing – enabling you to manage complex challenges with one trusted partner.
We operate under ISO 17025 accreditation and follow GMP, GLP, and EMA/FDA guidelines to ensure quality and compliance at every step.
Flexible development support
Our services range from targeted analyses and short feasibility studies to full-scale development programs. Smaller companies gain access to specialist expertise and infrastructure, while larger organizations can strengthen their teams with specific know-how or additional capacity when needed.
Contact
Need support in early development or scale-up? Get in touch to learn how we can help with expertise, infrastructure, and solutions tailored to your project.
