CordenPharma entered the synthetic Oligonucleotide manufacturing arena in CordenPharma Colorado. With a two phase investment, the strategic expansion will provide pharma and biopharma customers with a fully-integrated API to drug product service offering organized under a new Oligonucleotides Platform.

Phase one is the reconditioning of existing lab space, purchase of development equipment, and hiring of an expert team to set up process and analytical development capabilities, with a target completion in 4Q23.

Phase two includes the redesign of existing manufacturing space to create a fully GMP compliant manufacturing area housing synthesis, cleavage, downstream processing and lyophilization at 10-100 mmol scale.

The manufacturing assets provide early to mid-phase clinical trial supply for customer demands, with the benefit of being fully integrated with Italian facility CordenPharma Caponago for Lipid NanoParticle (LNP) formulation service offerings and sterile filling capability, as well as with multiple CordenPharma sites for the supply of standard and custom Lipid synthesis capabilities.

In addition, future expansions are being planned to increase capacity and scale capability. These high-demand services are being strategically designed to supply customers with validation and commercial supply solutions to address the largest gaps in the oligo market.

Michael Quirmbach, CEO and President of CordenPharma Group said: “Our entry into oligonucleotide manufacturing is strategically aligned with our goal to provide customers complex modalities and innovative supply solutions. The CordenPharma Colorado team brings profound peptide manufacturing and purification expertise and instills confidence in our ability to make informed investment decisions for an anticipated smooth and seamless manufacturing initiation. Combining Oligonucleotide API manufacturing with LNP Formulation Development, custom Lipid supply, and extensive Aseptic Filling capacity allows us to offer our customers bespoke service offerings with a truly end-to-end experience.”