CordenPharma Expands Aseptic Fill-Finish Capacity to 500 Million Sterile Injectable Units Annually
CordenPharma is advancing its long-term capital investment program at its FDA- and EMA-approved Caponago site near Milan, Italy, with a major expansion of its sterile injectable manufacturing capabilities. The multi-year investment program is designed to significantly increase aseptic fill-finish capacity and strengthen CordenPharma’s ability to support pharmaceutical and biotechnology companies across the development and commercialization lifecycle of injectable therapies.
The expansion comprises two complementary initiatives that will increase manufacturing capacity while broadening the range of injectable formats and complex modalities that can be supported at the Caponago campus.
€80 Million Investment Expands Caponago Manufacturing Footprint
As part of a multi-year investment commitment of €80 million in future injectable drug product manufacturing, CordenPharma has completed a €13 million acquisition of a new 11,000-square-meter commercial building and approximately 26,000 square meters of adjacent land.
The acquisition, completed on July 28, 2026, expands the Caponago site footprint by more than 50% and provides significant additional space for future sterile manufacturing operations.
Located adjacent to the site’s existing late-stage aseptic fill-finish manufacturing area, the new facility provides a flexible foundation for the development of fit-for-purpose manufacturing solutions for pharmaceutical and biotechnology innovators. The facility is designed to support aseptic fill-finish outsourcing for a broad range of injectable therapies, including peptides, lipid nanoparticles (LNPs), small molecules, biologics, and oligonucleotide-based drug products.
The expanded space is capable of accommodating at least four aseptic fill-finish manufacturing lines, four visual inspection lines, and four additional packaging lines. The facility can also support customer-owned production lines, large-scale lyophilization operations, and auto-injector assembly.
The expansion will further enable customers to access integrated injectable manufacturing capabilities alongside LNP manufacturing at the same Caponago campus, creating opportunities for more streamlined development and production of complex drug products.
New Aseptic Fill-Finish Lines Strengthen Near-Term Capacity
In parallel with the new facility expansion, CordenPharma has spent the past two years investing in its existing operational areas at Caponago. These initiatives are designed to increase near-term manufacturing capacity through the addition of two new aseptic fill-finish isolator lines.
The first is a clinical and small-scale commercial combination line from Bausch + Ströbel designed to accommodate pre-filled syringes (PFS), vials, and cartridges. The second is a high-speed PFS and cartridge line from Syntegon, with a production capacity of more than 500,000 units per day.
The company is also expanding its automated secondary packaging capabilities for PFS, vials, and ampoules to support increasing production volumes and a broader range of injectable formats.
In addition, CordenPharma is doubling its analytical capacity at the site to support a growing project pipeline and provide additional testing capabilities as manufacturing operations scale.
Completion of the new isolator lines is targeted for mid-2027 and 2028, respectively. These investments are intended to strengthen CordenPharma Caponago’s sterility assurance capabilities while supporting long-term regulatory compliance and reliable production of sterile injectable medicines.
Supporting the Growing Demand for Sterile Injectable Manufacturing
The combined investments represent a significant expansion of CordenPharma’s sterile injectable manufacturing platform, with total projected capacity of up to 500 million injectable units per year.
The additional capacity is designed to address increasing demand for specialized sterile injectable outsourcing across a range of therapeutic areas, including oncology, obesity, diabetes, and inflammatory diseases.
The expanded platform will support complex and high-growth modalities such as peptide-based GLP-1 therapies, oligonucleotides, LNP-based products, biosimilars, and other biologic medicines. By expanding its capabilities across multiple injectable formats and drug modalities, CordenPharma aims to provide customers with greater flexibility as products move from clinical development into commercial-scale manufacturing.
The investment also strengthens the company’s ability to offer integrated solutions spanning drug substance and drug product manufacturing. Through its global network of facilities, CordenPharma provides expertise across peptides, including oral peptide drug products, oligonucleotides, non-viral delivery systems such as LNPs, and small molecules, including both highly potent and non-potent active pharmaceutical ingredients (APIs).
Enabling Customers From Development Through Commercial Production
The expanded Caponago platform is designed to provide pharmaceutical and biotechnology companies with manufacturing flexibility throughout the injectable drug lifecycle.
For emerging therapies, the facility can accommodate clinical and small-scale commercial production requirements. As products advance through development and into commercial markets, the expanded manufacturing footprint and additional production lines are intended to provide a pathway toward larger-scale supply.
The ability to support multiple injectable formats — including pre-filled syringes, liquid and lyophilized vials, cartridges, and auto-injectors — further expands the range of products that can be manufactured at the site.
The combination of aseptic fill-finish, analytical testing, packaging, lyophilization, and access to LNP manufacturing capabilities at the same campus also provides customers with an integrated platform for increasingly complex drug products.
Dr. Michael Quirmbach, President & CEO of CordenPharma Group, said, “The support of our shareholders, Astorg, underscores our commitment to advancing sterile injectable manufacturing at CordenPharma Caponago. This strategic investment strengthens our leadership in the manufacture of drug products using complex modalities and enhances our end-to-end supply capabilities to meet rising global demand for injectable outsourcing, ultimately enabling partners to bring vital drug products in key therapeutic areas to patients more efficiently.”
With its expanded manufacturing footprint, new aseptic fill-finish lines, increased analytical capabilities, and projected capacity of up to 500 million injectable units annually, CordenPharma Caponago is positioned to play a growing role in the global sterile injectable supply chain.
The investment reflects CordenPharma’s continued focus on expanding specialized manufacturing capabilities in response to the evolving needs of the pharmaceutical and biotechnology industries, particularly as demand increases for complex injectable therapies and advanced drug delivery technologies.
