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.

To complement our existing sterile fill-finish capabilities, we have further invested in state-of-the-art robotic technology. This investment comprises two Cytiva Microcell Vial Filler units for earlier clinical scale manufacture and a larger scale Cytiva SA25 Aseptic Filling Workstation for later stage clinical through to commercial launch scale manufacture.

Through our GMP analytical testing laboratories, we will reduce supply chain complexity and expedite timelines, developing product-specific methods in-house or transfer existing validated methods.