Sterile Fill-Finish Manufacturing
Through our global network, PCI provide comprehensive sterile fill-finish services from development through clinical to large scale commercial manufacturing, a seamless end-to-end solution delivering true speed to market.
No matter your batch size or presentation, we will make every effort to minimize process loss and maximise the overall yield of your valuable drug product to ensure your life-changing therapies are delivered to those in need.
Scalable Manufacturing for Clinical and Commercial Supply
We work in harmony with our clients at every step of the manufacturing process, from early development through the entire lifecycle of the product. Our sterile manufacturing capabilities include filling solutions, emulsions and suspensions into vials, pre-filled syringes and dropper bottles. 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 200,000 units.
Formulation
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
- Jacketed Vessels
- Temperature Control Units
Complex Formulations
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 validate a sterile compounding process in our dedicated ISO 5 or Grade A formulation suites.
Our highly skilled team will work to fully understand your complex parenteral formulation and timelines before developing a unique program taking your customized process from the bench to GMP. PCI’s complex sterile formulation services include:
- Tangential Flow Filtration (TFF)
- Diafiltration
- Microfluidization/High Pressure Homogenization
- Ball Milling