STERILE POWDER LYOPHILIZED VIALS
CordenPharma has extensive experience in sterile contract manufacturing with a wealth of lyophilization expertise. In particular, the optimization of the freeze drying process as it relates to cycle times represents a critical attribute for complex parenteral product development. CordenPharma experts support customers’ product development to achieve product stability and improved shelf-life of products destined for clinical or commercial applications. Our fill-finish service for Sterile Powder Lyophilized Vials offers individual filling, suites with lyophilization capacity, along with an intrinsically safe process that enables the use of non-aqueous solvents.
Most notably, our scientists have garnered broad experience in the handling of the growing class of more complex molecules such as Peptides and mABs (mono-clonal Antibodies), in addition to common small molecules.
Sterile Lyophilization Filling currently takes place at CordenPharma Caponago, where separate and dedicated filling lines exist to handle non-potent compounds.
Our cGMP manufacturing facilities have classified areas for aseptic processing to minimize biological contamination. All personnel involved in sterile operations are fully qualified on aseptic techniques and Japanese quality standards.
Manufacturing Suites - CordenPharma Caponago
- >> Aseptic Filling using Nest & Tub technology & Materials
- >> Batch Sizes range from 1 - 50 L
- >> Vials from 2 R - 10 R
- >> Lyophilizer (1 sqm) with Capacity Range of up to 4,000 vials (2 R) - 1,000 vials (10 R) per cycle.
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. The Vial line can manage Liquid Formulation or Lyophilized Formulation, where the filling line is connected to a 5 sqm Lyophilizer able to handle up to 20,000 vials (2R) or 8,000 vials (10R) per freeze-drying cycle respectively.
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.