CordenPharma Re-Enters Synthetic Oligonucleotide Manufacturing Space

Edition 2 / June 2023

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Author
Dr. Stephen Houldsworth,
Senior VP, Global Head of Platform
Management & Marketing, CPI

Never Say Never: CordenPharma Oligos Are Back!

Oligonucleotide manufacturing suite at CordenPharma Colorado (US).

Never say never is one of those sayings I often use, especially when the course of strategy changes in unexpected ways. It is an appropriate phrase for this Corden Connect article!

Back in pre-pandemic 2017, we had announced our entry into the synthetic Oligonucleotide manufacturing space at our CordenPharma Colorado facility, and were making good progress on building out capacity and delivering on a number of projects. But by 2018, when faced with a shifting CapEx investment strategy and limited capital, CordenPharma management made the difficult decision to exit the Oligonucleotide manufacturing space and instead focus our efforts and technologies on funding several, equally good opportunities in other platform areas such as Peptides and Injectables. The decision to exit Oligos and sell the equipment helped fund these other growth areas at the time.

Fast forward 5 years, our company position is now drastically different, both because our new Private Equity owners Astorg have demonstrated a firm commitment towards investment in organic growth and ancillary space opportunities aligned with our scientific strategies to support innovative, complex modalities, and due to a record year-over-year sales growth in 2022. The time is now right for CordenPharma to re-enter the oligonucleotide manufacturing space. What made the decision easier was that a number of employees remained in CordenPharma Colorado from our first foray into Oligos, so they knew exactly what was needed and how it should be constructed this time around, having the benefit of 20/20 hindsight vision. This, combined with an even stronger drug product service offering today which includes expanded sterile drug product manufacturing, full LNP development and manufacturing capability, and extensive oral drug product services, creates an increasingly valuable integrated supply product offering for customers.

Thus, in May of this year, I was proud to announce CordenPharma’s re-entry into the synthetic oligonucleotide manufacturing arena at our CordenPharma Colorado facility under our new Oligonucleotides Platform. With an initial approximate $25 million budget, a two-phased approach has commenced.

Phase one is the reconditioning of existing laboratory space, purchase of development equipment and the hiring of an expert team to set up process and analytical development capabilities, with a target completion in Q4 2023. We are able to achieve this aggressive timeline because of our previous learnings and expert staff on board.

Phase two, which is also underway in parallel, 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. These manufacturing assets will provide early to mid-phase clinical trial supply for customer demands and are envisioned to come on stream in mid 2024.

Furthermore, future expansions are being investigated to cover increased 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 oligonucleotide market today and in the future.

As a stand-alone service offering for customers in the early clinical phases, we believe this two-phased approach will have great benefit. However, when taken in combination with our Lipid NanoParticle (LNP) formulation development and manufacturing services, sterile filling capability, standard lipid catalog and custom lipid synthesis manufacturing, we are confident customers will discover the unique potential that comes with access to a bespoke service offering with a truly end-to-end experience.

In the coming months, we will appoint a dedicated Platform Director for the Global Oligonucleotide Platform, finalize our complete product offering and begin to attend technology specific trade shows. Contact us if you would like to learn more about our Oligonucleotide Platform or about our integrated service offerings.