Contact person
Håkan Hollmark
Försäljning-och Marknadschef
Contact Håkan
Early-stage drug development presents critical challenges: Candidate selection, manufacturability, stability, and regulatory alignment all impact the success of your program. Efficient, data-driven decisions at this stage reduce risk, accelerate timelines and improve the likelihood of clinical success.
Early-stage drug development comes with critical challenges: candidate selection, manufacturability, stability, and regulatory alignment all influence the success of your program. Making informed, data-driven decisions at this stage reduces risk, accelerates timelines, and improves the likelihood of clinical success.
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 de-risk pathways 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.
We support early feasibility assessment, route scouting, and scalable synthesis—from milligrams to kilograms. Solid-state characterization, crystallization optimization, and analytical method development ensure that your compounds are well understood and preclinical-ready.
Early CMC planning and supply strategies facilitate smooth transitions from discovery to clinical evaluation.
Additional capabilities include handling of high-potency compounds, process safety assessments, and digital process modeling for efficient scale-up.
For proteins, antibodies, oligonucleotides, and mRNA, we assess stability, purity, and manufacturability to reduce risks of degradation or unwanted modifications. Our integrated capabilities include bioanalytical and structural characterization, formulation development (LNPs, freeze-dried products, conjugates), and preclinical readiness. We also address aggregation, adsorption, and viscosity challenges, ensuring robust formulations for complex biologics.
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.
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.
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.
In the early stages of drug development, choosing the right analysis and methodology is essential to reduce risk and build robust processes. Below are examples of services and techniques offered by RISE for small molecules and biologics.
Solid-state characterization & crystallization processes
XRPD, DSC, TGA, SEM, HSM to understand solid-state properties and optimize crystallization from milligram to kilogram scale.
Chemical process development & scale-up
Design and optimization of synthesis processes, continuous/batch operations, process analysis (UV-VIS, IR, NIR, RAMAN).
Chemical analysis & method development
HPLC/UHPLC, LC-MS/MS, GC-MS, NMR, FTIR – method development, validation, stability studies.
Protein and biologics analysis
LC-MS/MS, SEC, IEX, SDS-PAGE, ELISA – structure, aggregation, PTM, purity, stability.
Bioanalysis in biological matrices
LC-MS/MS, GC-MS – PK/TK/metabolites with GLP/GCP-compliant method validation.
Nanoparticle / LNP formulation
Development and characterization of lipid nanoparticles for mRNA, peptides – Cryo-TEM, release, stability.
Molecular biology analyses (qPCR)
Quantitative PCR for gene expression, DNA/RNA analysis, biomarkers.
Accreditations & standards
ISO/IEC 17025 laboratories, ISO/IEC 17021, 17024, 17065; CE-notified body.