Complex Formulation

Challenging formulation processes such as emulsions, suspensions, liposomes, polymer nanoparticles or Lipid Nanoparticles (LNPs) require a collaborative, creative and tailored approach to manufacturing.

PCI is a specialist CDMO able to deliver complex projects using:

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 macturing 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 cGMP manufacture of complex formulation projects:

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

Learn More
 

 

Our dedicated team of specialists will be happy to discuss our Complex Sterile Formulation Services with you. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

The trusted partner for global integrated CDMO services.

When it comes to sterile fill-finish and lyophilization manufacturing, you can rely on us.

Start your PCI experience today.

Your bridge between life-changing therapies and patients.