CDMO Services
Scale up seamlessly with integrated RNA therapeutics CDMO solutions
Axolabs CDMO platform encompasses early-stage discovery to commercial GMP production. Working in concert with our CRO team, we ensure data-driven decisions and a smooth transition from discovery through to clinical development and commercial success.
Early-stage synthesis & lead optimisation
We rapidly produce and optimise siRNAs, ASOs, aptamers, and gRNAs in 96-well plate formats. On-resin and post-synthetic conjugation (e.g. GalNAc, peptides, lipids) enables precise modifications.
- Automated purification (AEX, RP, SEC) for consistent yield.
- Customisable supports for unique conjugations.
Large-scale chemical manufacturing
Using OligoPilot™ (pilot) and OligoProcess™ AK Bio system (commercial), we scale from milligram batches to tens of kilograms under QbD/DoE-driven optimisation.
- Scalable workflows for GLP-tox, clinical, and commercial needs.
- Real-time process monitoring (UV, LC-MS) ensures quality.
cGMP production
Our Petaluma (USA) and Berlin (Germany) sites offer redundant cGMP suites for secure global supply. Production scales cover early-phase through commercial volumes.
- Petaluma: up to 300 mmol batch capacity.
- Berlin: pilot runs up to 10 kg per batch.
GMP analytics & quality control
We provide GMP-aligned analytical development, validation, and stability programmes, meeting EMA/FDA/ICH guidelines.
- High-resolution LC-MS/MS, uHPLC, FT-IR, and CE.
- Forced degradation and real-time data ensure robust release specs.
Integrated technology transfer
Unified QA oversight and project management bridge discovery data with commercial-scale requirements, minimising rework.
- Centralised documentation accelerates validation.
- Smooth transition from early development to market launch.
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Axolabs CDMO platform encompasses early-stage discovery to commercial GMP production. Working in concert with our CRO team, we ensure data-driven decisions and a smooth transition from discovery through to clinical development and commercial success.
Contact us
Find out morePartner with a global leader in oligonucleotide research, development, and manufacturing. Whether you need early-stage optimisation, large-scale GMP production, or specialised analytical support, Axolabs’ experts are ready to help. Get in touch to discuss your project, request a capabilities overview, or schedule a technical consultation.