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Integrated CDMO Services for Oligonucleotide & RNA Therapeutics

Axolabs end-to-end CDMO solutions connect early‑stage discovery, process development, and commercial GMP manufacturing, supported by coordinated CRO expertise to ensure data‑driven decisions and a smooth progression from research to clinical and commercial production.

A cleanroom laboratory at Axolabs Berlin CDMO site with advanced stainless steel equipment, control panels, and glass walls, designed for sterile pharmaceutical manufacturing.
Services CDMO

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The Axolabs CDMO platform provides an end to end continuum from early stage discovery to commercial scale GMP production. By integrating our discovery, analytical, and manufacturing teams with our CRO division, we ensure data driven development, streamlined technology transfer, and a seamless progression from research through clinical development to commercial success.

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Services CDMO

Early-stage oligonucleotide synthesis & lead optimisation

Axolabs provides high throughput early stage oligonucleotide synthesis for siRNA, ASOs, aptamers, sgRNAs, and other RNA modalities using 96 well platforms for rapid SAR and lead optimization. Our on resin and post synthetic conjugation capabilities enable precise GalNAc, peptide, lipid, and other ligand modifications to support next generation RNA therapeutic design.

Highlights
  • Automated AEX, RP, and SEC purification for consistent purity and reliable screening quantities.
  • Custom CPG supports enabling unique functionalizations and complex conjugate designs.
  • Integrated analytical QC (uHPLC, LC MS) ensuring identity, purity, and modification accuracy.
  • Seamless transition from discovery scale synthesis into Axolabs’ scalable CDMO and GMP manufacturing network.
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Image shows scientist working in product development at Axolabs Petaluma site
Services CDMO

Large-scale oligonucleotide manufacturing

Axolabs delivers scalable pilot to commercial scale oligonucleotide manufacturing using Cytiva’s OligoPilot™ and OligoProcess™ systems, together with AKB THESYS™ Synth100 and Synth1500 platforms in our Berlin cGMP facility. We reliably scale milligram to kilogram batches of siRNA, ASO, aptamer, and other complex oligonucleotides, supported by QbD/DoE driven process optimization.

Highlights
  • Scalable CDMO workflows for GLP tox, clinical, and commercial manufacturing.
  • In line UV and conductivity monitoring for consistent, high quality production.
  • High capacity synthesis platforms capable of producing a broad range of chemically modified oligonucleotides, conjugates, and proprietary chemistries with seamless tech transfer from pilot to commercial scale.
  • High‑capacity synthesis platforms for a wide range of modified oligonucleotides and conjugates, with seamless transfer from pilot to commercial scale.
  • Integrated analytical QC (uHPLC, AEX, RP, SEC, LC‑MS/MS) ensuring identity, purity, impurity profiling, and release testing throughout all manufacturing phases.
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A scientist in full cleanroom attire operates advanced stainless steel pharmaceutical processing equipment via touchscreen in a sterile laboratory environment.
Image shows OP400 at Axolabs Petaluma site
Services CDMO

cGMP production

Axolabs provides secure, dual site cGMP oligonucleotide manufacturing through our Petaluma (USA) and Berlin (Germany) facilities. Equipped with Cytiva OligoPilot™/OligoProcess™ and AKB THESYS™ platforms, we support reliable scale up from early phase to commercial production.

Highlights
  • Petaluma: up to 300 mmol batch capacity.
  • Berlin: commercial runs up to 1,500+ mmol per batch.
  • Dual site infrastructure ensuring global supply continuity.
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Image shows scientists using Oligo Process at Petaluma site
Image shows Axolabs scientist working on a purifier column
Services CDMO

GMP analytics & quality control

Axolabs provides GMP aligned analytical development, validation, and stability testing for oligonucleotide and RNA therapeutics, following EMA, FDA, and ICH guidelines. Our labs support identity, purity, and impurity profiling across all development stages.

Highlights
  • Advanced analytical suite: LC MS/MS, uHPLC (AEX, RP, SEC), FT IR, CE.
  • ICH compliant release and stability programs, including forced degradation and real time studies.
  • Integrated in process analytics ensuring robust, regulatory ready quality control.
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A close-up view of sample vials with blue caps arranged in a metal rack inside an analytical laboratory instrument at Axolabs CDMO site.
Two scientists wearing lab coats, gloves, and safety glasses work with sample trays and analytical instruments at Axolabs CDMO site.
Services CDMO

Integrated technology transfer

Axolabs ensures efficient, compliant technology transfer across discovery, process development, and GMP manufacturing. Unified QA oversight and coordinated project management align data, methods, and process parameters across our Petaluma and Berlin sites—reducing risk and minimizing rework during scale up.

Highlights
  • Centralized documentation streamlines validation and regulatory readiness.
  • Seamless transition from early development into clinical and commercial manufacturing.
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Two scientists wearing lab coats, gloves, and safety glasses discuss work at an automated liquid handling station at Axolabs CDMO site.
Two scientists in cleanroom suits inspect a stainless steel pharmaceutical system with complex tubing and multiple valves.

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Partner with a global leader in oligonucleotide research, development, and manufacturing. Whether you need early-stage optimization, large-scale GMP production, or specialized analytical support, Axolabs’ experts are ready to help. Get in touch to discuss your project, request a capabilities overview, or schedule a technical consultation.

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