CDMO-services for biologics

RISE supports the development of biological drug substances through detailed characterization, functional assessment, formulation expertise, and regulatory-aligned analytical methods. Our laboratories enable smooth progression from early discovery to clinical-ready material, with a strong focus on quality, reproducibility, and biological performance. By combining analytical capabilities with formulation insight, we guide development at every stage.

Services and areas of expertise

RISE offers specialized expertise and infrastructure across the full biologics development process, including:

• Analysis of active pharmaceutical ingredients (API) according to guidelines, covering identity, purity, and physical and biological properties.
• Development of appropriate API formulations to ensure stability, controlled release, and target exposure.
• Creation of formulation and analytical methods that can be scaled to clinical trial production (GMP).
• Assessment of how production methods influence biological function.
• Evaluation of potential toxicity or unwanted immune responses.

Our facilities support in vivo, ex vivo, and in vitro studies, preclinical safety assessments (toxicology), and GLP bioanalysis. Analyses can also be performed under ISO 17025-accredited activities. 

Tailored solutions for regulatory compliance

Each biopharmaceutical requires a customized approach to ensure all regulatory questions are addressed, including specificity, mechanism of action, pharmacology, safety, and quality of the substance and final product. RISE brings experience across all these areas, helping to develop strategies and supporting regulatory dialogue and documentation.

Why RISE?

With decades of experience in biologics development and formulation science, RISE provides multidisciplinary teams that deliver tailored solutions for complex modalities. We focus on regulatory compliance, biological functionality, and practical applicability.

Collaboration opportunities

RISE partners with pharmaceutical and biotech companies at any stage of biological drug substance development. Collaboration can include:

• Characterization and analytical evaluation of oligonucleotides, peptides, conjugates, and PROTACs
• Assessment of biological function, formulation strategies and analytical methods
• Production of clinical trial material
• Support for regulatory strategy, documentation, and CMC requirements

From early discovery to clinical material production, we deliver flexible, reliable, and regulatory-aligned solutions for complex biologic drug substances.