Scalable Manufacturing Of Sterile Drug Products

PCI Pharma Services’ comprehensive clinical to commercial scale manufacturing solutions offer seamless, end-to-end capabilities for developers, helping to bring products to market on-time and within budget. As you aim to improve patient outcomes with your novel therapeutic, consider harnessing the experience and expertise of a full-service CDMO that can provide insightful guidance and a robust infrastructure to deliver on the most challenging products.

During the move toward commercialization, developing sterile manufacturing processes that are scalable, reproducible, and commercially robust is essential. Overcoming solubility or stability challenges is a critical moment in this process, and PCI can develop and optimize your formulation for any parenteral route of administration. If an aqueous formulation does not yield the desired concentration, PCI can use complexing agents such as cyclodextrins or an organic solvent formulation to develop an emulsion or suspension.

A reliable contract services provider should also offer comprehensive sterile fill-finish services for clinical and commercial supply. PCI’s aseptic contract manufacturing capabilities include filling solutions, emulsions, and suspensions in vials, prefilled syringes and dropper bottles, and their aseptic freeze-dryers are designed with redundancy in mind, increasing manufacturing stability. As you take your customized formulation from the bench to GMP, consider the benefits of a CDMO partner that can support your production needs from development to commercial manufacturing.