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Håkan Hollmark
Försäljning-och Marknadschef
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Analytics for small molecules and biologics
Drug development is fraught with risk: unexpected toxicity, unstable compounds, and poorly characterized molecules can delay projects or halt them entirely. RISE provides integrated analytics for small molecules and biologics, reducing risk and accelerating preclinical readiness.
At RISE, we provide integrated analytical support for small molecules and biologics, ensuring compounds are well-characterized, stable, and preclinically ready. By combining chemistry, bioanalysis, formulation, and GMP-ready quality control, we reduce development risk and accelerate timelines.
Our modular approach allows you to select individual services - such as solid-state screening, structure elucidation, or bioanalysis - or engage a full analytical program that supports your candidate through early GMP supply.
Small molecules analytical services
RISE delivers tailored analytical support for small-molecule drug candidates, covering identity confirmation, purity assessment, and solid-state characterization. Our integrated approach ensures reliable data, regulatory alignment, and preclinical readiness.
Method development, validation & GMP-ready quality control
We design and validate analytical methods for identity, purity, and physicochemical profiling according to ICH Q2(R2) guidelines and aligned with EMA and FDA expectations. Methods are suitable for GLP- and GCP-compliant preclinical studies, ensuring data accuracy and regulatory readiness. Early GMP-aligned quality control ensures materials are fit for downstream development.
Chemical characterization & structure elucidation
Molecular structure insight is critical. Our team applies NMR, LC/GC-MS, IR, and UV/VIS spectroscopy to confirm identity, determine purity, stability, and content, and support informed decision-making throughout development.
Solid-State characterization & crystallization
Solid-state properties impact manufacturability and formulation. RISE offers XRPD, DSC, TGA, particle size analysis, porosity and hygroscopicity studies, as well as salt/co-crystal screening, crystallization optimization, and scale-up troubleshooting. Early solid-state insight reduces downstream risk and enables robust, scalable processes.
Bioanalysis & preclinical support
We provide quantitative and qualitative bioanalysis of small molecules in complex biological matrices to support preclinical pharmacology and toxicology studies, including GLP-compliant work. Sensitive and accurate assays allow confident PK/TK interpretation, supporting early candidate evaluation and regulatory submissions.
Analytical services – biologics
RISE provides comprehensive analytics for biologics, including structural integrity assessment, aggregation profiling, and bioanalytical evaluation. Our methods support early decision-making, formulation readiness, and seamless transfer to GMP-compliant clinical-scale production.
Structural characterization & integrity assessment
We apply a broad suite of analytical techniques for proteins, antibodies, oligonucleotides, and other biologics, including LC-MS/MS, SEC, RP/IEX chromatography, SDS-PAGE, peptide mapping, spectrophotometry, and ELISA. These analyses provide detailed insight into identity, purity, structural integrity, aggregation, heterogeneity, and post-translational modifications.
Bioanalytical Services
We develop and validate robust bioanalytical methods, including GLP-compliant approaches, supporting early-phase evaluation and regulatory requirements.
Stability, formulation readiness & preclinical analytics
RISE integrates analytical and formulation strategies designed for transfer to GMP-compliant clinical production. This approach enables early, data-driven decisions, mitigates risk, and accelerates the progression of candidates from discovery to preclinical studies.
Why RISE?
RISE combines deep scientific understanding with advanced analytical, bioanalytical, and formulation expertise to ensure small molecules and biologics are fully characterized, stable, and preclinically ready. Our integrated approach supports the transition from early candidate evaluation to robust, GMP-compliant material for preclinical and clinical studies, including safe handling of high-potency APIs (HPAPIs) and complex biologics.
We operate under ISO 17025 accreditation and follow GMP, GLP, and EMA/FDA guidelines to ensure quality, reliability, and regulatory compliance at every step.
Flexible analytical and development support
Our services range from targeted analyses and short feasibility studies to comprehensive, end-to-end analytical programs. Smaller companies gain access to specialized expertise and advanced infrastructure, while larger organizations can supplement internal teams with specific know-how or additional capacity as needed.
Contact
Need support with analytical characterization, bioanalysis, or preparation of clinical material? Get in touch to see how RISE can contribute expertise, infrastructure, and solutions tailored to your development program.
More information
Methods and standards we use
Our work combines advanced analytical techniques with internationally recognized standards to ensure reliable, regulatory-compliant results.
Predictive and computational approaches
- QSAR/QSPR modeling for early risk assessment
- AI- and ML-based toxicity and exposure prediction
- Weight-of-evidence (WoE) and human equivalent dose (HED) calculations
Bioanalytical techniques
- LC-MS/MS and GC-MS for quantitative and qualitative analysis
- ELISA and ligand-binding assays for biologics
- Ion mobility and high-resolution mass spectrometry for complex molecules
Safety testing and risk evaluation
- Mutagenicity screening (Ames test) according to ICH M7
- Impurity and excipient risk assessment using TTC and Cramer frameworks
- PK/TK analysis and non-compartmental modeling
Quality and compliance standards
- ISO/IEC 17025 accredited laboratories
- GMP, GLP, and EMA/FDA guidelines for nonclinical safety
- ISO 10993 and ISO 14971 for biologics and medical device safety
