From Clinical to Commercial: Comprehensive Sterile Injectable Platform Solutions
Investment in Injectables
In 2026, CordenPharma continues expansions in sterile injectables capabilities at our Caponago, Italy facility. Two state-of-the-art isolator aseptic fill and finish lines are being installed to supplement existing clinical and commercial filling assets. Expansions include:
- A clinical and small-scale commercial combo line from Bausch & Ströbel for Pre-Filled Syringes (PFS), vials, and cartridges.
- A high-speed PFS & cartridge line from Syntegon, capable of producing >500,000 units per day.
- Expansion of the automatic secondary packaging area for PFS, vials, and ampoules.
- A doubling of analytical capacity to support growing project pipelines.
Completion of the new isolator lines is targeted for mid-2027 and 2028 respectively, ensuring CordenPharma remains at the forefront of sterility assurance and long-term compliance during sterile injectable manufacturing.
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 expected to close in Q226). This state-of-the-art space can accommodate a minimum of four aseptic fill & finish lines, four visual inspection lines, and four additional packaging lines, with options for customer-owned lines, large-scale lyophilization, and auto-injector assembly.
The investment in these new and expanded facilities underscores a proactive approach to addressing the global healthcare industry’s increasing need for specialized injectable manufacturing, with fit-for-purpose aseptic fill & finish CDMO outsourcing of peptide, oligonucleotide, LNP, small molecule, and biologic-based injectable therapeutics, tailored to customers’ specific production setups and requirements.
Gain valuable access to our integrated solutions from drug substance to drug products, leveraging CordenPharma’s global facility network and expertise in manufacturing peptides, (including oral peptide drug products), oligonucleotides, non-viral carriers such as LNPs, and small molecules, including both highly potent and non-potent APIs.
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. 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.
Integrated Injectable Drug Products & Peptide Drug Substance
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