Contact person
Håkan Hollmark
Försäljning-och Marknadschef
Contact Håkan
Developing biologics
The development of biologics demands precision, robustness and a deep understanding of how structure, process and formulation interact. RISE provides integrated support across the entire development chain – from early drug substance characterisation to formulation, analytical method development and preparation for clinical material.
RISE offers end-to-end services for biologics development, where drug substance and product are developed in concert. We combine structural and functional analysis, formulation expertise and regulatory guidance to ensure each biologic is stable, reproducible and ready for clinical trials. Our multidisciplinary teams and laboratories enable a smooth workflow from early discovery to clinical material production, with quality, safety and biological performance at the forefront.
Services and areas of expertise
Drug substance characterisation
We establish identity, purity and molecular properties using guideline-aligned methods. Our analyses include both biochemical and biophysical approaches, providing a reliable foundation for further development.
Evaluation of biological function
Mode of action and potency are assessed using in vitro and ex vivo methods. This provides insight into how manufacturing processes influence biological performance and ensures the substance achieves its intended function.
Formulation and analytical method development
We develop biologic formulations and analytical methods that are scalable, robust and suitable for transfer to production environments. This includes nanoformulations, lipid nanoparticles and freeze-drying approaches.
Stability and reproducibility
We evaluate degradation pathways, storage stability and handling robustness to support lifecycle management, scale-up and regulatory submissions.
Vaccine development
RISE has extensive experience in vaccine development, including mRNA, DNA, viral vectors and recombinant proteins. We provide expertise in formulation, analytics, immunological studies and safety assessment. Our laboratories ensure vaccine identity, integrity and stability, supporting development through to clinical material.
Why choose RISE?
RISE combines advanced analytical capabilities, regulatory insight and hands-on experience with complex biologics. Our teams work cross-functionally and can take responsibility for either specific segments or the full development chain.
As an independent research institute, we offer a neutral, long-term partner focused on quality, reproducibility and sustainable development – not short-term delivery targets.
Flexible Collaboration
RISE works with biotech and pharmaceutical companies at all stages of development. We can undertake targeted technical assignments or act as a fully integrated development partner.
Our services include:
- Characterisation and analysis of oligonucleotides, peptides, conjugates and PROTACs
- Evaluation of biological function and formulation
- Production of clinical material
- Support for regulatory strategy and CMC documentation
Whatever the scale of the assignment, our goal remains the same: to create a predictable, knowledge-driven and quality-assured development process that moves your project confidently towards clinical trials and regulatory review.
