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Sterile Liquids

Proven & Compliant Sterile Liquid Manufacturing Expertise

Sterile drug product manufacturing requires dedicated and specialized capabilities which are compliant with FDA aseptic guidance and EMA regulatory requirements. With our long track record of experience in manufacturing parenteral sterile solutions and emulsions, we offer you a wide variety of delivery systems such as vials, Pre-Filled Syringes (PFS) and ampoules. Our state-of-the art injectable facility and equipment design, combined with highly skilled and trained personnel, are pivotal for the success of your sterile manufacturing.

In addition to specialized technologies in the aseptic fill and finish of complex modalities such as peptides, LNPs, oligonucleotides and biologics (antibodies and proteins), we also offer a wide range of terminal sterilization capabilities. Both areas have proven expertise in delivering pre-clinical development and services from clinical through to commercial supply.

Sterile Liquid Manufacturing
Technologies & Capacities

Aseptic Fill & Finish

  • 3 compounding rooms (1 clinical plant & 2 in commercial plant)
  • 3 filling lines (1 combo line in clinical plant, 2 in commercial plant)
  • Aseptic filling using ready-to-fill technology materials (Nest & Tub)
  • Batch sizes range from 1 to 100 L (can be increased to 300 L)
  • Vials range from 2R to 20R, and Pre-Filled Syringes (PFS) from 1 ml (Standard or Long) to 10 ml
  • Cartridges – 3 ml

Terminal Sterilization & Filling

  • 3 separate process rooms equipped with APV high-pressure homogenizers & solution vessels, with batch sizes ranging from 200 L to 1250 L
  • 5 filling lines (3 for vials, 1 for ampoules, 1 for Pre-Filled Syringes (PFS)/cartridges – custom)
  • 5 autoclaves (rotating)
  • Container range 10 – 100 ml (with optional 5 ml & 150 ml )
  • Inspection
    • Automatic inspection machines for 20 ml & PFS
    • Semi-automatic inspection machines for any other vials (50 ml & 100 ml)

Integrated LNP Formulation & Manufacturing Supply

CordenPharma offers customers cost-effective, end-to-end solutions for a fully-integrated supply of all products and processes needed for the formulation development and cGMP production of Lipid NanoParticle-based drug delivery systems.

  • Standard & custom lipid manufacturing
  • Sa/si/micro RNA, oligonucleotide, pDNA* and mRNA synthesis*
  • Pre-formulation screening (including lipids)
  • LNP formulation & process development
  • LNP process scale-up & cGMP manufacture
  • Sterile injectable drug product manufacturing of LNPs

*Via partnership with Wacker Biotech

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