Sterile Injectable CDMO Capacity Expansion

At CordenPharma, we continue to invest in the capabilities our customers need to bring innovative therapies to patients faster and more efficiently.

To support the growing demand for sterile injectable manufacturing, we have significantly expanded our long-term investment program at our FDA- and EMA-approved facility in Caponago, Italy. Through a multi-year investment initiative exceeding €80 million, we are creating substantial new capacity for aseptic fill & finish manufacturing while strengthening our integrated offering across complex injectable modalities.

Building for the Future of Sterile Injectables

A key milestone in this program was the recent acquisition of an 11,000 m² manufacturing facility and 26,000 m² of adjacent land located next to our existing sterile injectables operations in CordenPharma Caponago. Finalized on 28 July 2026, the expansion will increase the site’s footprint by greater than 50%.

For biotech and pharma alike, this milestone in our injectable journey provides a unique opportunity to design future manufacturing solutions around customer requirements. The new space is planned to accommodate multiple aseptic fill & finish lines, visual inspection capabilities, packaging operations, large-scale lyophilization, and autoinjector assembly. It also offers flexibility for dedicated or customer-owned production assets.

The facility is ideally suited to support a broad range of injectable products, including:

Pre-Filled Syringes (PFS)
Liquid and lyophilized vials
Cartridges
Autoinjectors

Customers developing peptide therapeutics, oligonucleotides, Lipid Nanoparticle (LNP)-based medicines, biologics, biosimilars, and small molecules will benefit from scalable manufacturing solutions designed to support products from clinical development through commercial supply.

New Capacity Already Underway

Alongside our long-term expansion plans, we are actively increasing manufacturing capacity through the installation of two new state-of-the-art aseptic fill & finish isolator lines for increased regulatory compliance and availability across clinical phase and commercial phases:

A flexible clinical and small-scale commercial line from Bausch + Ströbel for PFS, vials and cartridges.
A high-speed Syntegon production line for PFS and cartridges, capable of producing more than 500,000 units per day.

Additional investments include expanded secondary packaging capabilities and a doubling of analytical laboratory capacity to support growing project demand.

The new filling lines are planned for completion in 2027 and 2028, further strengthening our ability to support customers with reliable, high-quality sterile manufacturing services.

(Photo by Syntegon Technology) – FXS 5100 high speed PFS/PFC filling line from Syntegon.

Supporting Growth Across High-Demand Therapeutic Areas

As demand continues to accelerate in areas such as obesity, diabetes, oncology, inflammatory diseases and other specialty therapies, customers increasingly require manufacturing partners capable of scaling complex injectable products efficiently and securely.

Once fully realized, the Caponago expansion program has the potential to increase site capacity to approximately 500 million injectable units annually, enabling CordenPharma to support projects ranging from early clinical development to global commercial launch.

The Advantage of an Integrated Network

Beyond expanded fill & finish capacity, customers benefit from access to CordenPharma’s integrated development and manufacturing network. This includes expertise in peptides, oral peptide drug products, oligonucleotides, LNPs, highly potent APIs and small molecules, creating seamless pathways from drug substance through drug product manufacturing.

Why this matters for our customers

Greater capacity for clinical and commercial supply
Advanced aseptic filling technologies and isolator systems
Flexible solutions across multiple injectable formats
Integrated drug substance-to-drug product capabilities
Expertise in peptides, oligonucleotides, LNPs, biologics and small molecules
Long-term manufacturing partnership for growing product pipelines

This investment reflects our continued commitment to helping customers navigate increasing market demand while ensuring quality, reliability and scalability throughout the product lifecycle.

For clinical to commercial customers interested in arranging a meeting to discuss our new fit-for-purpose injectable expansion opportunities, please get in touch on our Aseptic Fill & Finish page.

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