RISE provides integrated discovery-phase support for both small molecules and biologics, combining expertise in chemistry, analytical characterization, formulation, and bioanalysis. Our approach enables confident decision-making early in development, helping you minimise risk and design scalable, regulatory-ready workflows that ensure a smooth transition to preclinical studies.

To strengthen your strategy, we offer predictive toxicology insights and impurity risk assessments, identifying potential safety or compliance issues before they become costly obstacles. When in vivo data are required, we assist with study design and connect you with trusted partners, ensuring studies are relevant, ethically sound, and aligned with EMA/FDA expectations from the outset.

We also integrate digital tools and AI-driven modeling to accelerate candidate evaluation and process optimization, and apply green chemistry principles to support sustainable development.

Tailored solutions by modality

Why RISE?

RISE combines deep scientific expertise with advanced technical infrastructure to deliver solutions that are integrated, scalable, and ready for regulatory requirements. We cover the entire chain – from chemistry and biological systems to formulation and analysis – enabling you to tackle complex challenges with a single 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

We offer everything from targeted analyses and short feasibility studies to extended development programs. Smaller companies gain access to specialist expertise and infrastructure that might otherwise be unavailable, while larger organizations can strengthen their teams with specific know-how or additional capacity when needed.

Contact

Need support in the discovery phase? Get in touch and learn how we can contribute with expertise, advanced infrastructure, and solutions tailored to your project.

At RISE, we combine scientific understanding of materials with advanced analytical and formulation expertise to design clinically viable dosage forms. Our integrated approach supports the transition from early concept to stable, GMP-compliant formulations for preclinical and clinical trials, including safe handling of highly potent active pharmaceutical ingredients (HPAPI).

Our drug product development services

We offer end-to-end capabilities across the drug product lifecycle – from dosage form design and solid-state evaluation to analytical method development, stability testing, and clinical manufacturing. Each formulation is tailored to the properties of the API, optimized for manufacturability and bioavailability, and produced as GMP-compliant clinical material under rigorous quality control.

Explore our drug product services or contact us directly to discuss your challenges and needs.

Why RISE?

RISE combines scientific understanding of materials with advanced analytical and formulation expertise to develop clinically viable dosage forms. Our integrated approach supports the transition from early concept to stable, GMP-compliant formulations for preclinical and clinical studies, including safe handling of high-potency APIs (HPAPI).

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

We offer everything from targeted analyses and short feasibility studies to extended formulation 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

Do you need support with formulation or clinical material preparation? Get in touch and learn how we can contribute with expertise, infrastructure, and solutions tailored to your project. 

The course is based on research developed within the RealHope project, funded by the Innovative Medicines Initiative 2, and supported by the EU’s Horizon 2020 programme. It will equip you with the knowledge to understand the lifecycle of biologics—from lab to patient—emphasizing both scientific principles and practical applications.

You will explore:

• The fundamentals of biologics, including their molecular complexity and therapeutic potential.
• Formulation strategies that ensure safety, efficacy, and patient convenience, covering excipients, delivery devices, and packaging considerations.
• Stability challenges unique to protein pharmaceuticals, such as aggregation, chemical degradation, and sensitivity to temperature, light, and mechanical stress.
• Delivery methods, including injection routes and barriers to oral administration, with a focus on improving bioavailability and patient compliance.
• Real-world handling, transport, and in-use stability, ensuring biologics maintain their integrity from manufacturing to administration.

Target group

The course is designed for professionals and students in the pharmaceutical and healthcare sectors. University educators can use the material in their teaching.

Practical

The course contains nine sections:

• What are biological drugs
• The delivery and safety of biologics
• Protein structure key for function and safety
• Stability issues for protein pharmaceuticals
• Specification for a biological product
• Formulation of biologics
• Risk related to handling of protein biological drugs in real life
• Transport of biologics
• In-use stability studies

Each section consists of two parts:

• Learning material: Here you can watch a video or read a PowerPoint presentation. They both contain the same information.
• Quiz: Here you can test your knowledge.

The course is in English.

Registration

The course is free of charge as it has been developed with financial support. You can register by clicking this link.

Land-based aquaculture and seafood industries consume large amounts of water and thus also generate a wide range of residual water streams of varying quantity and quality. Some are extremely rich in salt and nutrients, such as phosphate, nitrogen and organic carbon. Current methods for wastewater treatment are very expensive and energy-intensive. In addition, valuable nutrients are lost from the food chain, and in the best case are instead used for low-value purposes such as biogas. At the same time, the demand for new and sustainable resources for the production of food, materials and energy is increasing.

Cultivation of microalgae in wastewater streams could solve this dual problem. Microalgae are microscopic organisms that have a unique ability to carry out photosynthesis and efficiently convert dissolved nutrients into biomass in the form of protein, omega-3 fatty acids, carbohydrates and carotenoids.

The specific aims of SEAlgaePower are to optimize pilot-scale algae cultivation and wastewater cleaning; develop biorefinery protocols for protein, lipid, and carbohydrate recovery from the microalgal biomass; and to develop microalgae-based product prototypes and ingredients in a bioprospecting manner. RISE will here focus specifically on the development of fiber-based materials for wound healing and regenerative medicine using high molecular weight carbohydrates and proteins as well as on the encapsulation of bioactive lipids, pigments, and peptides.

What regulations and policy tools are needed to bring tomorrow’s medical breakthroughs into today’s healthcare systems? That is the guiding question behind a new research initiative that puts governance and policy development – not technology itself – at the center. Focusing on precision medicine for inflammatory bowel disease (IBD), the project investigates how legal frameworks can enable the safe and effective use of cutting-edge technologies such as synthetic biology, multi-omics, and AI.

Through policy labs, testbeds, and an iterative process, the project develops new models for regulation and governance – always with real-world healthcare conditions and patient benefit in focus. The technological potential is vast: tailor-made biomolecules, genetically engineered cells, and predictive AI models may revolutionize how chronic diseases are treated. But innovation depends on regulatory readiness.

Led by RISE in collaboration with Region Skåne Innovation, Örebro University, and Pfizer AB, the project addresses legal and policy challenges that currently hinder progress. The outcome will provide concrete guidance for decision-makers and healthcare providers seeking to embrace innovation without compromising safety, integrity or quality of care.

The versatility of nanoparticles enables co-delivery of RNA adjuvant and mRNA vaccines within the same formulation platform. This creates a synergistic effect where the adjuvant enhances the ability of the vaccine to stimulate a robust and durable immune response. 

The project aims to strengthen the collaboration between RISE, PAI Life Sciences and HDT Bio on these formulations, to jointly seek long-term funding for the development of RNA delivery systems. 

The long-term goal is the development of next-generation carrier particles and adjuvant and RNA formulations for more effective vaccines. In the project we successfully developed and analyzed three innovative nanoparticle systems for RNA adjuvants and mRNA vaccines. Results demonstrated that mRNA binding and release can be controlled in these fundamentally different particular systems.

The ultimate goal is safer vaccines for a wide range of patients, including those with underlying health conditions that make them more vulnerable to side effects. 

The process step, which has proven problematic, is crucial for controlling the level of contaminants in the final product and the process yield has a significant effect on the amount of chemicals and solvents required in the preceding manufacturing steps.

Two new methods have been developed that avoid the use of large amounts of dichloromethane, which is both hazardous to health and a burden on the environment. One of the methods shortens the process by one step, making the process even more cost-effective and less environmentally damaging. The project has provided increased knowledge about how critical impurities are formed. The project objectives have been achieved and will form an important basis for continued process development.

Expected effects of the project include a significant reduction in environmental impact and improved workplace safety by eliminating organic solvents. 

Results will demonstrate the scalability and economic viability of the manufacturing process of novel lipid mixtures, validate the use of the latter mixtures in oral drug delivery, and contribute to more effective, sustainable pharmaceutical formulations.

The pharma sector has a significant impact on the environment; in terms of CO₂ emissions, use of water, energy, solvents and fossil-based raw materials, as well as generation of a lot of waste.

By implementing cutting-edge technologies and methodologies across different manufacturing stages, the project strategically targets critical environmental concerns like the reduction/elimination of solvents and substitution of toxic chemicals and reagents, while advancing resource efficiency, operational sustainability, and eco-friendly production methodologies.  

PHARMECO will also harmonise the way sustainability assessments of pharmaceuticals are carried out, by delivering guidelines that are scientifically-robust, practical, and accepted by all stakeholders.

PHARMECO will address the production of small molecules, tides, and biologics, medical devices & technologies, with a key focus on: Safe and Sustainable-by-Design (SSbD) platforms for early-stage pharmaceutical development. Green processes for industrial-scale manufacturing and decontamination. Advanced digital tools for sustainability assessment and decision-making.

Together, the project outputs will form a comprehensive toolkit to support the development and manufacture of more sustainable pharmaceuticals and to evaluate their environmental impact along the whole life cycle.