Sterile Powder Lyophilization Expertise
CordenPharma has extensive experience in the sterile manufacturing of lyophilized drug products from formulation and lyophilized cycle development, to clinical and commercial manufacturing. In particular, our optimization of the freeze drying cycle time represents a critical attribute for complex parenteral product development that can reduce the cost of goods and increase your throughput.
Our experts support your sterile powder development to achieve stability and improved shelf-life of drug products destined for clinical or commercial applications. With comprehensive fill and finish services for sterile powder lyophilized vials, our filling suites offer lyophilizers capable of safely handling non-aqueous solvents as well.
Your sterile powder supply chain will benefit from our team of scientists, with broad experience in working with and analyzing complex modalities such as peptides and oligonucleotides (and their various conjugates), antibodies (including monoclonal), and proteins, as well as traditional small molecules.
Our Sterile Powder Manufacturing Capabilities Include:
- Aseptic filling using Ready-To-Fill (RTF) materials (Nest & Tub)
- Batch sizes range from 1-50 L (clinical plant) and 10-100 L (commercial plant)
- Vials from 2-20 R
- Clinical plant: Lyophilizer (1 sqm) with a maximum capacity range of 4,000 vials (for 2R vials per cycle) to 1,000 vials (for 10R vials per cycle)
- Commercial plant (also late-stage clinical): Lyophilizer (5 sqm) with a maximum capacity range of 22,000 vials (for 2R vials per cycle) to 10,000 vials (for 10R vials per cycle)
Sterile Injectable Packaging
We provide a broad spectrum of packaging services for sterile injectable drug products, including both terminal sterilization and aseptic filling technologies for Pre-Filled Syringes (PFS), vials, ampoules, cartridges, and lyophilized vials with a wide range of filling volumes, as well as the capability for combination products.
Want to find out more?
Get in touch with our team of experts to explore bespoke end-to-end CDMO support of your complete drug lifecycle
at any scale.