The first phase, the Germany-based CDMO said, will see the reconditioning of existing laboratory space, purchase of development equipment and hiring of an expert team to set up process and analytical development capabilities. This is due to be completed by the 2023 fourth quarter.

Phase 2, being launched simultaneously, is to include 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 company said the upgraded facilities at Boulder will be fully-integrated with CordenPharma Caponago in Italy, with an eye to providing early- to mid-phase clinical trial support for customers. The Italian site can provide lipid nanoparticle (LNP) formulation service offerings and sterile filling capability, while multiple other of its worldwide sites can provide standard and custom Lipid synthesis capabilities.

CordenPharma said further expansion stages in planning will increase capacity and scale capability, with the high-demand services 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 the CDMO’s entry into oligonucleotide manufacturing is strategically aligned with its goal to provide customers complex modalities and innovative supply solutions.

The team in Colorado – the plant was acquired from Pfizer in 2017 – can mobilize profound peptide manufacturing and experience, Quirmbach said, noting that 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.”

In January, the CDMO announced a multi-year deal with an undisclosed customer to manufacture large-volume peptides at the US site, which it said could be worth as much as $1 billion and support the launch of a new peptide.

Additionally, CordenPharma aims to invest more than €200 million in expanding global capacity for peptides, lipids and injectables.

Author: Dede Williams, Freelance Journalist