Complex Sterile Formulations

Our experience with a wide variety of novel drug products paired with our flexible cleanroom space offers a solution to challenging formulation processes. If your product cannot be sterile filtered or terminally sterilized, we will develop and validate an aseptic compounding process in our dedicated ISO 5 or Grade A aseptic 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
• Aseptic Ball Milling

As no two processes are the same, we systematically transfer complex manufacturing to our GMP facilities. If you are in the early stages of development and need scale-up, we can develop a formulation process from scratch or scale-up your lab-scale process to GMP for clinical phases. If you need to transfer an existing manufacturing process, our technical SMEs will work with you to understand the utility requirements of your equipment train while ensuring the safe transfer of the process.
 

PCI offers analytical characterization to support the development and GMP manufacture of complex formulation projects:

• Particle Size Analysis
• Dissolution Profile Type II and Type IV
• Oxygen Headspace
• Gas Chromatography
• Ribogreen

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