Sterile Drug Product manufacturing requires dedicated and specialized capabilities which are in compliance with FDA aseptic guidance and EMA regulatory requirements. CordenPharma has a long track record of experience in manufacturing Parenteral Sterile Solutions and Emulsions in different pharmaceutical forms such as ampoules, vials and pre-filled syringes. Our facility and equipment design, combined with experienced and trained personnel, is pivotal for success in sterile manufacturing. Currently, CordenPharma Caponago of the CordenPharma network is involved in Sterile Liquid Drug Product manufacturing.
CordenPharma Caponago has two main areas of production with a focus on Non-Potent traditional Small Molecules, through its long-standing expertise in Terminal Sterilization, and Aseptic Fill & Finish, through special expertise in the handling of large molecules such as Peptides, mRNA, Oligonucleotides, Carbohydrates and Biologics.
CordenPharma is also uniquely positioned to offer a specialized Lipid portfolio (Standard and Custom Lipids capabilities) in an integrated supply solution for the formulation and fill & finish of complex molecules.
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) /Cartridge – custom)
- >> 5 Autoclaves (rotating)
- >> Container Range 10 – 100 ml (option 5 ml and 150 ml )
- >> Inspection
- >> Automatic Inspection Machines for 20 ml & Pre-filled Syringes (PFS)
- >> Semi-Automatic Inspection Machines for any other vials (50 ml & 100 ml)
Aseptic Fill & Finish
- >> Aseptic Filling using Nest & Tub Technology & Materials
- >> Batch Size range from 1 to 50 L
- >> Vials from 2 to 10 R and PFS from 1 ml (Std or LONG) to 10 ml
CordenPharma Caponago finalized construction and operations of a new Commercial Aseptic Fill & Finish plant hosting 2 different lines (segregated one from the other) for Pre-Filled Syringes (approved in late 2018) and Vials (approved mid 2020) respectively. This Aseptic filling capability is an addition to the Aseptic Clinical plant previously approved in early 2016.
CordenPharma Caponago has been authorized by the main MoH Agencies (FDA, EMA, TGA, ANVISA, Japanese Authority) to distribute products worldwide. Our manufacturing process is highly sophisticated and includes automatic inspection, packaging and serialization.
CordenPharma’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs), Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.