CordenPharma provides CDMO services that elevate pharma & biotech customers to support complex modalities across the drug development spectrum. By aligning our facilities and technology platforms to anticipate the challenges innovators often encounter as they work through development phases towards commercial markets and patients, CordenPharma offers bespoke end-to-end services. Staying at the forefront of science and growing our capacities in line with the expanding demand and expectations of our customers has required the organization to invest heavily in a wide range of programs in 2024, 2025 and beyond.
With our fully-integrated supply model as an overarching focus, CordenPharma has made recent, significant investments across all six technology platforms (Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides).
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Peptide Platform Receives Record Investment for Expansions in Small to Large-Scale Peptide Production
On 16 July 2024 we announced our largest strategic investment to date to grow our Peptide technology platform with a committed spend of ~€900m over the next 3 years. These transformational plans consist of two major expansion initiatives occurring in parallel in the US and Europe, including both existing facilities and new constructions designed and built according to the pharmaceutical industry’s most stringent quality and technical standards for short and long peptide manufacturing, including Biologics License Applications (BLA) requirements.
In addition to enhanced large-scale manufacturing, our multi-pronged approach to becoming the #1 peptide CDMO supplier extends to small-scale capabilities at our Peptide Centre of Excellence in Frankfurt, Germany with the commissioning of new GMP capacities to manufacture early clinical phase peptide APIs for pharma and biotech customers. The investment will be fully operational and authorized by German authorities in Q4 2024.
The Frankfurt site will add 1000 m2 of manufacturing space, including two fully equipped lines comprised of a Solid Phase Peptide Synthesizer (SPPS), High Pressure Liquid Chromatography (HPLC), Liquid Phase (LP), isolation equipment and quality control laboratories including In Process Control (IPC), starting material batch release, and GMP stabilities. The GMP manufacturing area is designed to produce peptide APIs from gram to kilogram range for clinical phase 1 and 2 requirements.
Lipids & Carbohydrates Platform: Investments to Drive the Creation of New Complex Modalities
CordenPharma stands as a global leader in pioneering lipid-based products for pharmaceutical development. With a remarkable track record over four decades, CordenPharma has collaborated extensively with the research, pharmaceutical, and diagnostic sectors to deliver cutting-edge solutions that push the boundaries of science and support pharmaceutical innovators’ complex modalities for their life-saving medications.
CordenPharma’s continuous pursuit of specialized lipid innovation has resulted in an expanded portfolio of diverse custom and catalog lipids that draw upon our legacy of excellence in synthetic lipid process development. As a leader in the scale-up and large-scale manufacturing of commercial lipids, CordenPharma is an early innovator holding Drug Master Files (DMFs) on some of the industry’s most utilized lipids that have been proven efficient and effective for Lipid NanoParticle (LNP) formulation.
Our ongoing, substantial capital investment and development efforts in custom lipid synthesis are demonstrating efficacy and utility in delivering advanced complex RNA therapeutics.
In CordenPharma Liestal (CH), a dedicated area has been introduced with Supercritical Fluid Chromatography (SFC) both at pilot scale and GMP production scale, mirroring our capacity built in France, to ensure flexibility and a business contingency plan for our global customers. In Switzerland, more than 80 highly skilled specialists will be hired (for development and analytic services) to work in the newly built area at the site.
Injectables Platform Investment for Fully-Integrated cGMP manufacturing of LNPs
CordenPharma Caponago (IT) has completed a €15m investment for the cGMP Manufacture of Lipid NanoParticles (LNPs) and other Nanoparticles such as Polymeric and Peptide Nanoparticles. The 900m2 area, which is Grade C throughout, is now ready for fully scalable clinical and commercial manufacture of cGMP LNPs. Furthermore, the FDA and EMA approved site already offers clinical and commercial Fill Finish into Vials and PFS and benefits from having over 30 years of sterile manufacturing expertise. Full integration allows for LNP formulation and process development at the same site and a wide variety of catalogue and custom Lipid manufacture, along with nucleic acid manufacture within the CordenPharma network and through our partnership with Wacker.
In addition, our Caponago site has approved and ordered a new high-speed Pre-Filled Syringe (PFS) / cartridge filling line using the latest isolator technology. The line, which will fill via Nest & Tub with ready-to-use primary packaging, can fill up to 30,000 units per hour (including 1% In-Process Controls) and will be able to accommodate batch sizes up to 500 L, including OEB5 compounds. This €30m investment will provide CordenPharma with an additional 50 m units of late-stage and commercial injectable manufacturing capacity and it will be online by 2027.
Lastly, our injectable site has recently completed a €6m upgrade of a new, centralized, automated packaging department. The expansion increases packaging capacity and efficiency to better serve current and future customers more effectively. With a total floor plan of more than 2150m2, the packaging area is located on the ground floor of the new LNP manufacturing building, conveniently located next to the SAP controlled warehouse, and boasts 4 automatic filling lines and 2 semi-automatic filling lines to allow high-speed secondary packaging of PFS, Vials and Ampoules.
Highly Potent & Oncology Platform Investment in OSD Clinical Trial Development with Bioavailability Enhancement
Because Oral Solid Dose (OSD) capabilities are in high demand, CordenPharma made the strategic decision to enhance our offering with an investment of €10 million into the design and installation of a new GMP Clinical Trial Development (CTD 4) facility located in CordenPharma Plankstadt (DE) as a response customers’ demands and the recognition of gaps in scale and technologies. Joining three other CTD facilities (CTD 1: 1-5 kg GMP; CTD 2: 5-20 kg GMP; CTD 3: non-GMP), CTD 4 will bridge the scale gap between CTD 2 and the two large-scale production facilities to manufacture GMP batches up to 60 kg. CTD 4 will be equipped to address all key oral solid dosage manufacturing needs including blending, granulation (high shear, fluid bed, roller compaction), compression, and coating. Investments in high potency filling equipment (powders, granules, pellets, minitablets) into capsules, hot melt extrusion, and the ability to operate with organic solvents are also being added.
Our CordenPharma Plankstadt facility has become CordenPharma’s Drug Product Innovation Centre of Excellence for the development and manufacturing of both non-potent and highly potent OSD products for compounds with OEL levels as low as < 1 µg/m3. Additional investments have been made into the Centre of Excellence to incorporate technologies to enhance bioavailability and enable the formulation of NMEs with challenging properties – such as peptides and small molecules with limited solubility, permeability, very low drug load, high potency, and limited stability – into highly complex Oral Solid Dose drug products. Our enabling technologies such as spray drying, hot melt extrusion, nanomilling, and micronization solve dissolution rate- and solubility-limited absorption issues.
For peptides or large molecules that exhibit limited bioavailability caused by poor permeability through the intestinal barrier, lipid-based formulations (e.g. SEDDS / SMEDDS, sLNP, Cochleates) or permeation enhancer-based formulation technologies are required. To address these challenging APIs, we apply innovative formulation approaches to provide prototypes for animal in vivo investigations for oral peptide delivery. All formulations can be manufactured as a solid form, allowing for larger production scale. Throughout 2025, CordenPharma will be making additional investments into this new exciting area with equipment for co-precipitation and larger batch sizes for manufacturing clinical trial materials.
CordenPharma Strengthens Small Molecule Capabilities: Investments in Centres of Excellence and Production Sites Worldwide
CordenPharma has recently announced a series of significant investments in our Small Molecule production facilities which are part of our long-term strategy to expand worldwide production capacity while enhancing specialized Centres of Excellence that support drug substance and drug product development. The latest expansions focus on sites in Liestal, CH, Plankstadt, DE, Chenôve, FR, and Lisbon, PT, incorporating advanced technology and increased production capacity in key areas such as small molecules APIs, lipids and solid dosage forms.
CordenPharma Switzerland: Investment in the Solid State Centre of Excellence
CordenPharma’s recently invested 4m Swiss Francs towards our Solid State Centre of Excellence (CoE) in Liestal, Switzerland. This CoE plays a crucial role in the development and optimization of drug substance manufacturing to increase capabilities in the development of small molecules and solid dosage forms. The research and development work conducted in Liestal is primarily focused on improving purification, isolation and the solid-state properties of APIs.
Integration with the Bioavailability Enhancement Centre of Excellence at CordenPharma Plankstadt
In addition to the investment in Liestal, the Solid State CoE has been integrated with the Bioavailability Enhancement Centre of Excellence in Plankstadt, Germany. This integration allows us to improve the bioavailability of active ingredients, a key factor for drug absorption and effectiveness. Plankstadt is known for its expertise in enhancing the solubility and absorption rate of APIs, which is particularly important for poorly soluble compounds.
Expansion of Production Capacity at the Chenôve Site
CordenPharma has also invested €35m into our Chenôve, France site to significantly expand its production capacities for small molecules. The expansion completed phase 2 of an overall investment started in 2021. Phase 1, completed in 2022, included the renovation of an R&D laboratory and the addition of several analytical instruments, a GMP mid-scale purification unit, and a newly-hired, focused team of experts. Phase 2 includes the design and construction of a larger GMP manufacturing facility at CordenPharma Chenôve, with a manufacturing concept which increases production capacity to provide customers with multi-metric tons of small molecules using modern chemical reaction, isolation and purification equipment.
New Production Line for Oral Solid Dosage Forms in Lisbon
At our CordenPharma Lisbon site, we invested in a new production line for OSD forms. This investment includes €1.3m for a modern tablet coater (Hütllin, Sepion 250) and €2.9m for a new bottling line (expected to be finished in the first half of 2025) to expand the production capacity for oral solid drug forms such as tablets. The new equipment in Lisbon not only increases overall production capacity but also expands capabilities for coated tablets earning several benefits, such as controlled release, taste masking, and protection of the active ingredients.
Oligonucleotide Platform Investment Addresses Largest Gaps in Oligo Market
CordenPharma was pleased to announce in 2023 we have re-entered the oligonucleotide manufacturing space with an initial ~$25 Million budget in two phases, backed by record year-over-year sales growth, and reinforced with new Private Equity owners Astorg and scientific strategies to support innovative, complex modalities.
Phase one of the program, 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, was successfully completed in the summer of 2024. 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 10-160 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-2026. Future expansions are being investigated to cover increased capacity and scale capability strategically designed to supply customers with validation and commercial supply solutions to address the largest gaps in the oligonucleotide market.
2024-2025 Investments Increase Efficiency for Faster Time to Market & Better Patient Outcomes
Fully-integrated supply, continuous improvement and large investments in six technology platforms across our network help customers span the gaps in development, commercialize their products more efficiently, and reach patients faster. With expanded capacity, capabilities, expert teams and cutting-edge technology across Europe and the USA, CordenPharma brings bespoke end-to-end services tailored to support your innovative complex modalities for increased efficiency, faster time to market and better patient outcomes.
