CDMO Stewardship: Navigating Together with Innovators Towards the Bright Future of Pharma

Since its launch in 2021, I have had the honor of kicking off the Q1 Corden Connect editorial every year. While on my way to DCAT 2025 in New York City – one of the major partnering trade shows for the CDMO industry – I am reflecting back on our hard work over the last year, and what lies ahead in 2025 for the CDMO, pharma and life sciences industry. Despite global economic uncertainty, the objective for us at CordenPharma is clear – to make sure we align with our organizational mission every day to provide innovative Biotech and Pharma companies with the cost-effective and efficient support needed to help them navigate changing industry shifts and bring medicines to market that improve their patients’ outcomes.

As the Pharma industry continues to evolve and innovate, I am always proud to learn about the launch of new products where our employees contributed significantly, whether it be through our profound scientific understanding, proven processes, state-of-the-art technology or experience in clinical to commercial development and manufacturing. One example is our specialized production of ultra-high pure Lipids at our Liestal, Switzerland facility for gene therapy applications, and their subsequent formulation / encapsulation into Lipid NanoParticles for the gene therapy market, which remains one of the most exciting fields in pharma R&D despite its recent challenges.

To enhance our support for the Injectable market, I am pleased to announce the installation of a new high speed Pre-Filled Syringe (PFS) and Cartridge line and a new combo production line that can fill PFS, Cartridges and Vials, including lyophilization, at our Caponago, IT facility. Both of these lines are Isolator based and will be operational by mid-2027 to meet the increasing demand of Fill & Finish services for complex modalities.

Other segments such as the development and manufacturing of oral solid dosage forms, both for normal and highly potent & oncology products, remain our focus. In this area, we invested > €10 Million into the design and installment of a new cGMP facility for the manufacturing of Oral Solid Dose (OSD) drug products at our Plankstadt, Germany site, which will enable the supply of cGMP batches for clinical trials or commercial use, ranging from 5 to 60 kilograms. The facility has been designed with multi-purpose capability, including hot-melt extrusion, and can handle highly potent compounds, operate with organic solvents, and work under controlled manufacturing conditions to maintain humidity levels between 30-35% RH. After a successful operational completion last year, it is expected to receive regulatory approval during the May / June 2025 timeframe.

Moving to a larger indication such as Diabetes and Obesity – the mega trend is called GLP-1 and the industry is facing unprecedented growth of the market to > €130 Billion by 2030, with only two major players currently on the market, and many more in the pipeline. The majority of these drugs are based on Peptides and to a smaller extent Small Molecules. To support the growing demand in this segment we announced the construction of a new manufacturing facility in Switzerland outside Basel. With a targeted completion in 2028, this will allow us to serve additional customers from mid to large scale, while continuing our Colorado, US site expansion with a more than $500 million investment in both mid to large-scale peptide manufacturing as well.

Within the peptide market, I am proud of the team at our Frankfurt, Germany facility that received GMP certification of our new clinical GMP production area in January 2025. This Centre of Excellence for Peptide development and small-scale manufacturing supports Phase I/II peptide projects with a strong emphasis on speed and efficient development and scale-up. Additionally, it augments our global integration of small, mid and large scale peptide manufacturing in both the US and Europe to provide seamlessly integrated supply of peptide-based drug substance, subcutaneous formulations and oral peptide drug products across our facility network.

We have been striving to provide valuable updates over the last years on trends, innovative technologies and broad service offerings across our network of 11 manufacturing sites and 6 technology platforms. To that end, I am always eager to hear back from you with any ways to better serve your project needs or strengthen our capabilities. In this context we will continue to ask you for feedback as part of our project execution process and plan to launch a larger customer survey –  I promise you it will be short, meaningful and comprehensive – when we hope your valuable participation will help sharpen our focus on ways to better support you.

In 2025 we will continue to pursue our ambitious growth plan as part of a long-term strategic objective and as previously shared, by thriving for exceptional customer experience and strong commitments towards sustainability. In this context we announced the submission of our Science Based Targets initiative (SBTi) reduction targets at the end of 2024, which our Chief Quality & Compliance Officer William Cashin will discuss in his sustainability video update in this edition. We will also hear about the key considerations for robust LNP manufacturing from our Lipids & LNP Platform Associate Director Dr. Serra Gürcan, as well oral solid dosage forms – the journey from powders to compacts – by our Preformulation & Galenical Development Scientific Expert Dr. Markus von Raumer.

Furthermore, we will continue our strong commitment to create a vibrant and encouraging working culture for our employees through our People Strategy. Our people make the difference every day in the success of your projects!

Thanks again for being a loyal and valued customer in 2024 and we look forward to meeting existing and new customers in 2025. As always, I welcome any suggestions or feedback you might have on how we can better serve you – with the ultimate goal to be your long-term partner!