AXOlabs

Axolabs provides integrated contract research and manufacturing services for nucleic acid therapeutics, spanning discovery through commercial-scale GMP production.

CRO Services

Discovery: Lead identification and chemistry optimization using bioinformatics-driven design, proprietary sequence selection algorithms, high-throughput screening, and RNA-Seq-based off-target analysis. The Kulmbach facility houses a deep bioinformatics platform and multiplex screening infrastructure.

Preclinical: Preclinical safety, pharmacokinetics, and biodistribution studies; early synthesis and process development to support IND/CTA submissions. Capabilities include solid-phase oligonucleotide synthesis and conjugates, GLP-compliant bioanalysis (proprietary PNA assay), LC-MS/MS assays, and advanced cell-based functional testing.

CDMO Services

Preclinical Manufacturing: Non-GMP to GMP manufacturing, process development, and synthesis scale-up for toxicology studies. Synthesis of chemically modified oligonucleotides and conjugates with advanced in-process controls and comprehensive impurity profiling.

Clinical & Commercial GMP: GMP-compliant production of nucleic acid therapeutics (ASOs, siRNA, sgRNA, aptamers, bioconjugates) for clinical trial phases I–III and initial commercial supply. Dual-site, globally integrated facilities equipped with Cytiva OligoPilot™, OligoProcess™, and Asahi Kasei Bioprocess (AKB THESYS™) platforms. Comprehensive analytics, in-line process monitoring, and regulatory-compliant validation.