End-to-end CDMO services for biologics
Developing biological drugs – from oligonucleotides, peptides, PROTACs, and conjugates to antibodies and mRNA – places high demands on both substance and product levels. Stability, reproducibility, maintained biological activity, and controlled delivery are critical factors. Advanced formulations, including nanoformulations, require deep expertise in particle characterization, functional analyses, and in vivo behavior.
RISE supports the development of biological drugs through detailed characterization, functional assessment, nanoformulation, and analytical strategies. Our expertise ensures quality, reproducibility, and biological performance across the entire development chain, from early discovery to clinical material.
How we can support you
Characterization of Active Pharmaceutical Ingredients (API)
Identification, purity, physicochemical and biological properties, including stability, aggregation, and impact of manufacturing parameters.
Functional Assessment
In vitro and ex vivo studies to understand how manufacturing and formulation techniques affect biological activity.
Formulation Expertise, Including Nanoformulation
Design of formulations to ensure stability, controlled release, and optimal exposure in biological systems.
Design and characterization of nanoparticles and other advanced delivery systems for sensitive molecules:
- Lipid-based: LNPs, liposomes, nanocapsules, cubosomes
- Polymer-based: nanogels, dendrimers
- Inorganic: mesoporous silica, titanium dioxide, nanoclays
Nanoparticles and nanoformulations protect molecules, enable controlled release and targeted delivery, and require robust characterization of particle size, morphology, structure, interactions, and drug release.
Toxicity and Immunogenicity Risk Assessment
Identification and quantification of undesired immune responses and potential toxicity to minimize risks along the development chain.
Analytical Methods and Laboratory Support
Support for the development and validation of analyses within ISO 17025, bioanalysis, and preclinical safety studies, including in vivo models via partners.
Tailored Strategies
Each biological substance and product requires a customized strategy to ensure that all regulatory and biological parameters are addressed. We provide guidance and support in:
- Substance characterization and functional analysis
- Formulation selection and stability
- Toxicity, immunogenicity, and risk mitigation
- Strategic planning and regulatory documentation
Why RISE?
With decades of experience, our multidisciplinary teams combine analytical expertise, biological insight, and formulation knowledge. We deliver solutions and guidance that enable the development of complex biological drugs and nanoformulated products with high reproducibility and regulatory feasibility.
Collaborations in biological drug development
RISE can support projects at all stages of development, from early substance discovery to clinical material, with flexible, science-based solutions. Collaboration may include:
We provide expert-level support in the characterization and analytical evaluation of oligonucleotides, peptides, conjugates, PROTACs, and antibodies, as well as assessment of biological function, formulation, and nanoformulation. Our laboratories also develop and deliver analytical methods to support preclinical studies.
For longer-term development partnerships, we offer guidance across multiple stages of substance and product development, integrating strategies for formulation, biological function, and regulatory requirements.
We also engage in joint research projects focused on new biological modalities, advanced delivery systems, and analytical technologies, and we develop and validate innovative methods that support the next generation of biological drugs.
