By partnering with PCI for your sterile fill-finish and lyophilization needs, you are leveraging our versatile contract manufacturing capabilities and successful regulatory history.
No matter your batch size or presentation, we will make every effort to minimize process loss and maximize the overall yield of your valuable drug product to ensure life-changing therapies are delivered to those in need.
We work in harmony with our clients at every step of the manufacturing process, from early development through the entire lifecycle of the product. With nine automated fill-finish lines, we have the flexibility to sterile fill a range of dosage forms with batch sizes from a few hundred units up to 60,000 units.
Our standard aqueous formulation process takes place in an ISO 7 or Grade C controlled environment. Based on your product’s unique characteristics we can employ the use of:
- Glass Carboys
- Stainless Steel Vessels
- Disposable Biobags
When products are heat sensitive and require cooling or need to be warmed to fully solubilize the API, PCI is able to provide tight control with one of our temperature control units and jacketed vessel options. We can maintain the temperature of your product between 2°C and 50°C during both formulation and filling.
PCI has experience with a wide variety of novel drug products and complex formulations, such as polymer nanoparticles and Lipid Nanoparticles (LNPs). If your product cannot be sterile filtered or terminally sterilized, we will develop and qualify an aseptic formulation process in our dedicated ISO 5 formulation suites.