One-stop service from laboratory scale to GMP manufacturing

Building on more than 20 years of small-molecule process-development experience from preclinical studies through commercialization, our oligonucleotide platform supports preclinical sample preparation and GMP manufacturing of oligonucleotide drug substances and formulations in line with domestic and international regulatory requirements. Coordinated process, analytical, formulation, and regulatory teams provide an efficient, professional, and flexible integrated development solution.

The platform includes 20 senior oligonucleotide R&D and analytical professionals, with managers who each bring more than 10 years of relevant industry experience. Technical capabilities include large-scale solid-phase synthesis of oligonucleotides and modified oligonucleotides, scale-up of ultra-long oligonucleotide chains, large-scale liquid-phase synthesis, coupled purification chromatography, structural characterization, and analytical-method development and validation. The service scope includes modified and unmodified antisense oligonucleotides, RNAi, RNAa, morpholino oligonucleotides, aptamer oligonucleotides, peptide-oligonucleotide conjugates, and self-assembling RNA nanomedicines.

Advanced facilities and equipment

The oligonucleotide platform is equipped with GE ÄKTA solid-phase nucleic-acid synthesis and purification systems from laboratory through workshop scale, supporting gram-to-kilogram production. QTOF, UPLC-MS, UPLC, GPC, and other analytical systems support structural characterization, method development and validation, GMP in-process control, final-product release testing, and stability studies.

Why work with us?

A mature project-management system, comprehensive facilities, and a customer-focused service model support rapid response from quotation through delivery. GMP and EHS systems support regulatory inspections, including those by the US FDA and NMPA. Our collaborative approach and professional services are designed to accelerate customer drug-development programs.