Leveraging decades of solid-phase peptide manufacturing experience and extensive downstream processing capacity and capabilities, CordenPharma is pleased to announce their decision to enter the synthetic oligonucleotide manufacturing arena in CordenPharma Colorado.
With an organic capex investment in two phases, the strategic expansion will provide innovative biotech and pharma customers with a fully-integrated API to Drug Product service offering organised under a new oligonucleotides platform.
Phase one is the reconditioning of existing laboratory space, purchase of development equipment, and hiring of an expert team to set up process and analytical development capabilities, with a target completion in Q4 2023.
Phase two, which is being initiated at the same time as phase one, includes the redesign of existing manufacturing space to create a fully GMP compliant manufacturing area housing synthesis, cleavage, downstream processing and lyophilisation at 10-100 mmol scale. These 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.
Furthermore, 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.
Dr Michael Quirmbach, CEO & President of CordenPharma Group commented: “Our entry into oligonucleotide manufacturing is strategically aligned with our goal to provide customers with complex modalities and innovative supply solutions. The CordenPharma Colorado team brings profound peptide manufacturing and purification expertise and instils 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.”