Lyophilization and Sterile Manufacturing Services
Our global manufacturing capabilities in complex formulations, high potency, and lyophilization covers a broad range of injectables including nanoparticles, mRNA, mABs, proteins, oligonucleotides, and other biologics across multiple delivery formats from vials and bottles to pre-filled syringes and autoinjectors.
We provide integrated large and small molecule solutions for clinical and commercial projects, and with over 20 years in the sterile fill-finish and lyophilization manufacturing space, we are dedicated to your success in bringing life-changing therapies to patients.
Lyophilization and Sterile Manufacturing Services
PCI focuses on developing sterile manufacturing processes that are scalable, reproducible, and commercially robust. We utilize a Quality by Design (QbD) approach to provide you with a product that meets your critical quality attributes. Whether you are facing solubility or stability challenges, we can develop and optimize your formulation for any parenteral route of administration. If lyophilization is required to support the long-term stability of your product, PCI is able to develop a lyophilization cycle to provide you with a commercially elegant presentation of your product.
Over the years we have built our reputation as the go-to, full-service CDMO that our clients trust with their sterile manufacturing needs. Our reputation has been earned by providing insightful guidance and a robust infrastructure to deliver on the most challenging products on time and on budget.
PCI delivers unmatched quality to our clients globally. We perform rigorous analytical testing services for sterile products to support in-process, release, and ICH stability testing. We can perform analytical method development, support efficient method transfers, and phase-appropriate validation to further your testing needs.