CordenPharma Injectables: Flexible Solutions Fueled by Passion, Growth, & Expansion

(CordenPharma Photo) New Pre-Filled Syringe (PFS) Filling Lines are being added to supplement existing Clinical and Commercial PFS Assets.

From development to commercialization, injectable outsourcing often presents many challenges (e.g. formulation development challenges with solubility or stability, filling challenges related to your product’s unique physical characteristics, or multi-faceted secondary packaging requirements). Did you know CordenPharma is expanding injectable capabilities with investments to nearly double capacity by 2028? Having trouble securing reliable injectable CDMO capacity? Regardless of the challenges your program faces, CordenPharma is the partner you need.

Located 20km outside of Milan, Italy, our CordenPharma Caponago site combines 30 years of Injectable Drug Product experience with cutting-edge technologies to provide flexible solutions that solve the biggest challenges innovators face. We excel in developing and manufacturing your small molecule as well as complex modality-based programs (e.g. peptides, oligonucleotides, recombinant proteins, monoclonal antibodies).

For Injectable Drug Products, our capacity to help clients develop and deliver innovative therapies has been accelerated by significant growth and investment in our Caponago site:

• Our Research & Development laboratory is doubling in size in 2025, enabling the onboarding of additional equipment and highly trained scientists.
• To supplement existing clinical and commercial filling capabilities, the site has invested in two new isolator filling lines, both targeted for GMP-readiness by the end of 2027: 1) A Syntegon commercial-scale PFS/PFC filler, strengthening Caponago’s ability to support high-volume commercial programs, and 2) a VarioSys Bausch+Stroebel line, designed to support clinical and small-scale commercial programs across vials (liquid / lyophilized) and Pre-Filled Syringes / Pre-Filled Cartridges (PFS/PFC).
• Approximately €6m has been invested in the site’s secondary packaging area, including six packaging lines ranging from manual to fully-automated, providing both clinical and commercial labeling and packaging capabilities.
• CordenPharma is in the final stages of acquiring a new property adjacent to the existing Caponago site. This expansion, which will be finalized by January 2026, will increase our footprint by 11,000m² providing multiple options for additional aseptic fill & finish, visual inspection, auto-injector assembly and secondary packaging lines, as well as warehousing.

The Power of Our Technology Platforms & True End-to-End Integrated Supply

A benefit of partnering with CordenPharma can be realized in efficiencies gained through integrated offerings. Organized across six technology platforms, our global network of experts works seamlessly to deliver Small Molecules, Lipids & LNPs, Peptides, Oligonucleotides, Highly Potent & Oncology, and Injectables. For innovators seeking the value of true end-to-end supply, the Injectables platform is a perfect complement to our other API/drug substance platforms, as complex modalities often require an injectable route of administration. An example of integrated supply is noted in our recent press release announcing a partnership with Viking Therapeutics to manufacture its Dual GLP-1/GIP Receptor Agonist peptide API along with both parenteral and oral solid dosage forms.

Customers opting for integrated supply with CordenPharma benefit in a variety of ways, including but not limited to: streamlined documentation (contract, MSA, Quality Agreement), management of shipping / logistics, corporate level program governance, and a singular Quality System across sites, with full transparency across dedicated cross-functional project teams to achieve project milestones.

A second opportunity to capitalize on CordenPharma’s platform synergies can be found in the recently AIFA-approved state-of-the-art Lipid Nanoparticle (LNP) suite built at the Caponago site. Lipid nanoparticles and non-viral carriers, designed to deliver therapeutic agents to targeted locations, can be manufactured in the LNP suite and transferred for use in aseptic filling operations, all under one roof. Watch our LNP GMP Manufacturing video or contact us here for further information on LNP projects.

CordenPharma Injectable Services: Driving Your Drug Product from Pre-Clinical to Commercial Success

With corporate vision built on core values of Integrity, Transparency, and Flexibility, we deliver the true collaboration required to overcome common obstacles encountered in Injectables manufacturing, such as filter selection, the use of fully disposable or dedicated product contact pathways, and utilization of either mechanical or vacuum stoppering for PFS.

Moreover, the Caponago site boasts an impeccable compliance record, with successful audits from global regulatory authorities (e.g. FDA, EMA, ANVISA, and various Ministries of Health).

Working with small molecules and complex modalities at all points along the CMC spectrum, CordenPharma Injectables services offer cost-competitive solutions to help innovators achieve clinical milestones and support commercial demand, driving success for their injectable programs and the patients they serve.