CordenPharma understands today’s pharma market demands and is investing in key technology platforms – Small Molecules & Highly Potent Drug Substance and Drug Products, Injectables, Peptides, Lipids & LNPs – to provide customers with true end-to-end support. With expanded capacity, upgraded infrastructure, and an integrated global network across Europe and the US, we help innovators reduce complexity, mitigate risk, and accelerate timelines, ensuring efficient progress from early development through commercial supply for their patients worldwide.
From Discovery to Dose: Advancing Small Molecule & Highly Potent Platform Drug Substance
In 2025, CordenPharma reinforced our Small Molecule Drug Substance capabilities with major investments designed to meet growing customer demand. In Liestal (CH), we are wrapping up a five-year facility renovation to expand purification and small-scale development capacity. Our Chenôve (FR) site now features new 6,000 L reactors with enhanced isolation and drying capability, while our Bergamo (IT) facility added a 12,000 L multi product, state-of-the-art manufacturing line, plus upgraded warehousing and increased hydrogenation infrastructure. These enhancements provide customers with substantial, ready-to-use capacity for both standard and highly potent small molecule APIs.
Our small molecule drug substance services guide innovators through every stage of API development, from route scouting and process optimization to purification, micronization, solid-state design, and continuous flow chemistry. By addressing complex chemical, stability, and bioavailability challenges early, we reduce risk, accelerate timelines, and ensure scalable, high-quality supply.
Solid-state optimization remains central to our approach. We support customers with polymorph screening, salt and co-crystal selection, solubility testing, and tailored crystallization development designed to deliver robust APIs that perform reliably in downstream formulations. Advanced analytical tools, including DSC, TGA-FTIR, DVS, particle size distribution, and X-ray diffraction, provide the data needed to move confidently through development and regulatory review.
For highly potent APIs, our US Colorado facility offers secure, scalable containment for APIs with occupational exposure limits as low as 0.05 µg/m³. By combining process optimization and purification under cGMP, we deliver high potency APIs with minimal risk and maximum reliability from early clinical supply to commercial scale.
At Chenôve (FR), our Flow Chemistry Centre of Excellence enables customers to tackle complex reactions that are challenging in batch mode, including electrochemistry and photochemistry, opening access to a wider range of molecules faster and more efficiently.
Purification solutions across our network span crystallization, preparative chromatography, Supercritical Fluid Chromatography (SFC), and Tangential Flow Filtration (TFF). All technology transfers follow a risk-based, Quality by Design (QbD) approach, with small-scale trials and Design of Experiments (DoE) ensuring reproducible, compliant scale-up.
By combining deep expertise, expansive capacity, and strategically located facilities across Switzerland, France, Italy and the US, we help innovators advance their non-potent and highly potent small molecule drug substance efficiently and reliably, delivering the supply and support needed to bring medicines from discovery to patients.
Bringing Molecule to Market: Small Molecule & Highly Potent Platform Drug Products
In 2025, CordenPharma has expanded Small Molecule and Highly Potent Drug Product services to meet growing global demand. Our Plankstadt (DE) facility now features a medium-scale Oral Solid Dosage (OSD) line capable of handling both non-potent and highly potent compounds with OEL levels as low as <0.05 µg/m³. This line bridges small- and large-scale capacities, supporting early-stage development as well as clinical and commercial manufacturing, addressing formulation challenges, enhancing bioavailability, and enabling production of complex OSD products. Flexible dosage forms such as minitablets and precision capsule filling facilitate adjustable dosing and modified release profiles, ensuring safe, accurate, and efficient delivery from first-in-human studies to commercial supply. In Lisbon (PT), new roller compactors and tablet coaters enhance formulation flexibility, while additional oral liquid filling lines at Fribourg (CH) provide efficient supply for diverse dosage forms. Both Lisbon and Fribourg have extensive primary and secondary packaging capacities to provide full, end-to-end manufacturing and distribution capability with experience supplying to over 70 countries worldwide.
Selecting the right partner for OSD drug product development and manufacturing is critical. CordenPharma accompanies your products across the entire lifecycle, from early phase formulation development and clinical supply through late-stage registration, validation, and commercial manufacturing. We handle APIs with OELs down to the picogram per cubic meter level and support both small molecules and peptides. Our structured approach incorporates biopharmaceutic principles for early phase screening, compatibility assessments, and scalable process development. With expertise in blending, dry and wet granulation, tablet compression, coating, encapsulation, and more, we deliver immediate or modified release forms across tablets, capsules, minitablets, granules, and pellets. Phase-appropriate, science-driven, risk-based process development, technology transfers, and analytical support ensure smooth scale-up from hundreds of grams to commercial production, meeting global regulatory standards.
Working closely with our Solid State Centre of Excellence, we provide fully integrated API and Drug Product services, creating a continuous feedback loop to identify the optimal API form for absorption, solubility, stability, and processability. From developability assessments to technology selection, screening studies, prototype development, and Accelerated Stability Assessment Programs (ASAP), we move products efficiently into First-in-Human (FIH) studies and beyond.
Our oral peptide delivery services complement robust peptide drug substance offerings, providing end-to-end integrated supply. Absorption is enhanced through strategies such as increased lipophilicity, reduced degradation, and improved membrane permeability, combined with formulation technologies including permeation enhancers, SMEDDS, and LNP carriers. These capabilities ensure reliable progression from early development through commercial supply.
From Clinical to Commercial: Comprehensive Injectable Platform Solutions
Investment in Injectables
In 2025, CordenPharma continues expansions in sterile injectables capabilities at our Caponago, Italy facility. Two state-of-the-art isolator filling lines are being installed to supplement existing clinical and commercial filling assets with completion targeted in 2027.
One line is designed for Pre-Filled Syringes (PFS) and cartridges, handling batch sizes up to 500 L and filling up to 30,000 units per hour. This line is ideal for clients with large-scale Phase III and commercial manufacturing needs. The second line offers flexible filling of vials (liquid / lyophilization), PFS, and cartridges, perfectly suited for clinical and small-scale commercial programs.
In addition, our Caponago site will increase its footprint by almost 50% with the planned acquisition of an 11‘000 m2 commercial building adjacent to the existing late-stage and commercial Aseptic Fill & Finish facility (negotiation to be closed by end of 2025),
This state-of-the-art area will drive CordenPharma’s continued growth within aseptic manufacturing of complex modalities, with plans to include up to 4 more aseptic filling lines, 4 automatic inspection lines, and 3 secondary packaging / auto injector lines, along with additional warehouse and office space. These investments afford customers additional capacity and flexible solutions throughout the lifecycle of their injectable program, ultimately reducing risk and accelerating time to market.
Beyond capacity expansions in aseptic filling, CordenPharma Caponago has recently doubled the size of its analytical development laboratory, augmented its highly skilled team of scientists, and invested €6 million in secondary packaging capabilities. Further investments including robotic container handling, ready-to-use (RTU) primary container usage, and automated visual inspection underscore CordenPharma’s position as an innovative leader in the injectables space.
CordenPharma continues to help customers navigate critical aspects associated with injectable development and manufacturing. Examples include analytical method transfer, pre-manufacturing preparation, drug substance handling, formulation development, lyophilization cycle development and/or optimization, Annex I compliance, process validation, and regulatory support. Post-filling activities extend to manual or automated visual inspection, labelling, secondary packaging, storage, and phase-specific quality control and release processes.
The Power of Integrated Injectable Offerings
In addition to experience with standard small molecule programs, CordenPharma Caponago is well-equipped to execute across multiple complex modalities, including biologics (e.g. mAbs and recombinant proteins), peptides, oligonucleotides, and Advanced Therapy Medicinal Products (ATMPs) such as Lipid Nanoparticles (LNPs) and other non-viral carriers. Consequently, injectables development and manufacturing expertise is the perfect complement to CordenPharma’s other five platforms. Customers can harness the power of our integrated supply by coupling drug substance and drug product services to benefit from time and cost savings as well as streamlined documentation and risk mitigation.
CordenPharma’s capabilities for true end-to-end supply are exemplified by our integrated peptide–injectable services combining our Frankfurt (DE) Peptide Centre of Excellence with Caponago’s sterile injectable capabilities, giving customers the advantage of a single CDMO relationship, integrated contract, and full transparency through a global program management organization with oversight to project activities at both sites. This streamlined model provides access to reference standard qualification, formulation, analytical method development and validation, and technical writing support for IND/IMPD submissions – ensuring a seamless path from peptide API to finished injectable drug products.
Peptide Platform: Scaling Innovation from Grams to Metric Tons
Peptides have rapidly moved to the forefront of modern therapeutics, and we at CordenPharma have made bold commitments to ensure our customers have the scale, reliability, and innovation needed to succeed. Over the
past year, we have initiated large expansions in our global peptide platform to respond to customers’ demand and reinforce our position as the market leader in fully integrated peptide supply.
In our CordenPharma Colorado site, we continue to undergo major expansions by adding new large-scale manufacturing lines and a greenfield facility that will more than double our Solid Phase Peptide Synthesis (SPPS) capacity to over 42,000 L by 2028, positioning it among the largest peptide production sites worldwide. In parallel, CordenPharma continues to evaluate strategic acquisition opportunities to further enhance our peptide capabilities, ensuring alignment with our long-term growth strategy.
To complement our large-scale injectable capabilities, our Frankfurt Peptide Centre of Excellence has added 1,000 m² of GMP space for early-phase API production, from grams to kilograms. By linking Frankfurt directly with our Caponago, Italy and Plankstadt, Germany facilities for sterile injectables and oral peptides respectively, we provide customers with a seamless path from API to finished dosage forms for first-in-human trials. This integrated peptide-injectable-OSD offering accelerates the time-to-market and enables customers to benefit from a single CDMO relationship while also accessing API route selection, solubility studies, characterization, reference standard qualification, formulation development, analytical method development and validation, and technical writing support for IND/IMPD submissions.
Just as important as scale is the way we manufacture. We combine SPPS, LPPS, and hybrid approaches to deliver everything from peptidomimetics to complex conjugates, with advanced purification and isolation to support reliable outcomes at any scale. We are also pioneering more sustainable methods, such as TAG-Assisted Peptide Synthesis (TAPS), which reduces solvent use by >90% and cuts raw material requirements by half. Alongside innovations in continuous chromatography, PAT, and Supercritical Fluid Chromatography (SFC), these approaches reduce environmental impact while improving efficiency and cost-effectiveness.
By expanding capacity, advancing technology, and building strategic partnerships, we are ensuring that our customers can rely on us to deliver peptide medicines from early development all the way to global commercialization. From grams to metric tons, we are committed to being the most trusted peptide partner bringing innovation, speed, and sustainability to every stage of the journey.
Lipids & LNPs Platform: Powering the Future of Nanomedicines from Nucleic Acid Vehicle to Vial
Leveraging four decades of experience in lipid process development, scale-up, cGMP manufacturing, and regulatory support, CordenPharma’s Lipid offerings support customers in developing groundbreaking lipid-based medicines with both custom and standard synthetic lipids. Our portfolio spans high-quality standard excipients, custom-designed functional lipids, and fatty acid side-chains for long-acting peptides, delivering added value across multiple therapeutic modalities. With fully integrated supply, we help innovators progress smoothly from discovery through commercialization, ensuring quality, consistency, and security of supply.
We continue to invest in lipid innovation that gives customers a competitive advantage. From ultrapure fatty acid side chains enabling GLP-1 receptor agonists, to targeted lipid designs for organ-specific delivery, to analytical validation that proves unmatched purity, our lipid solutions are built to improve efficacy, stability, and patient outcomes while streamlining the path to market.
In March 2025, our Caponago (IT) site received GMP certification from AIFA / EMA to manufacture non-viral vectors, including Lipid Nanoparticles (LNPs) and polymeric nanoparticles. This follows a 2024 LNP expansion that added ~900 m² of GMP facilities with advanced assembly suites, purification rooms, dispensing areas, and compounding capabilities. With this milestone, we provide customers a compliant and scalable foundation to accelerate their nanomedicine programs.
To ensure flexibility, we offer multiple LNP assembly technologies – including Impingement Jets Mixing and NxGen Microfluidics – at both R&D and GMP scale. This allows customers to continue with their preferred platform or switch seamlessly to optimized methods, maintaining robust quality, scalability, and consistency throughout development.
Our LNP starter kits further simplify early-stage work by providing pre-dissolved, pre-weighed lipid components for rapid formulation screening. Substitutions such as β-Sitosterol have demonstrated significantly higher mRNA transfection efficiency, giving customers a valuable tool to boost performance.
We also enable more precise delivery through both passive and active targeting approaches. Beyond tailored lipid compositions, we collaborate with pHLIP® to provide peptide-coated nanoparticles that exploit the acidic environment of diseased tissues, enhancing therapeutic impact in areas such as oncology.
Downstream, our expertise in Tangential Flow Filtration (TFF) ensures stability and efficacy of LNP formulations by removing residual solvents, reducing ethanol content, and concentrating final drug products into their formulation buffer. Whether in early development or commercial scale, customers benefit from reliable purification processes that safeguard quality.
Together, our lipid and LNP capabilities exemplify true end-to-end nanomedicine support. From small to large-scale lipid excipient supply to LNP formulation, purification, aseptic fill & finish, and regulatory guidance, we provide a fully integrated solution that reduces complexity, accelerates timelines, and gives innovators confidence to successfully bring their LNP-based nucleic acid medicines from vehicle to vial.
Powering the Future of Pharma Outsourcing
CordenPharma is powering the future of outsourced development and manufacturing by investing boldly in the technology platforms that matter most. With integrated solutions spanning drug substance to drug product and packaging, we give innovators the confidence to scale breakthroughs into therapies that transform patient outcomes and define the next era of medicine.
Get in touch with our team of experts to explore bespoke end-to-end CDMO support of your complete drug lifecycle
at any scale.