Girindus and Axolabs are combining their capabilities in oligonucleotide lead optimization, manufacturing, and analyses. The aim is to offer customers complete service solutions for therapeutic oligonucleotides from early discovery and preclinical development through clinical stages and into commercialization.
Axolabs offers analytical and bioanalytical services as well as small-scale manufacturing for a variety of DNA and RNA oligonucleotides. The services also cover all steps from lead identification and optimization as well as non-GLP pharmacology and early safety assessment. Girindus handles process development, analytical method development, and cGMP manufacturing of oligonucleotide therapeutics from pre-IND development through scale-up to kilogram production, process validation, and commercial manufacturing at its FDA-inspected plant in Cincinnati.
The combined service solutions cover the whole therapeutic development chain and eliminate the need to transition processes between vendors, Grindus and Axolabs point out. The companies believe that their long-term alliance will reduce timelines, risks, challenges, and costs for customers active in drug development and approaching scale-up.
“Our combined skills and experience provide everyone developing oligonucleotide therapeutics with a unique platform covering almost all possible technical needs,” notes Marc Lemaître, CEO of Girindus America. “This is a significant upgrade in CMO/CRO offering and a great opportunity for our customers.”