Complex Aseptic Formulation
Challenging aseptic formulation processes such as emulsions, suspensions, liposomes, polymer nanoparticles or Lipid Nanoparticles (LNPs) require a collaborative, creative and tailored approach to manufacturing. We understand not every CDMO is willing to take on your complex project, but we love challenges and have the grit and determination to see every project through.
LSNE is the CDMO that wants to work with you.
Our experience with a wide variety of novel drug products paired with our flexible cleanroom space may be the solution for your challenging formulation process. If your product cannot be sterile filtered or terminally sterilized, we can develop and validate an aseptic compounding process in our dedicated ISO 5 or Grade A aseptic formulation suites. Our highly skilled engineers will work diligently to fully understand your complex parenteral formulation, important timelines, and will then develop a unique program for you to take your customized process from the bench to GMP. LSNE’s complex sterile formulation services include:
- Tangential Flow Filtration (TFF)
- Microfluidization/High Pressure Homogenization
- Aseptic Ball Milling
LSNE 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
Vice President of CMC for an Academic Spinout
We need a CMO who can not only meet our technical and schedule requirements but can also provide needed expertise that we just don’t have in house. And above all else, a partner who won’t let us down when challenges arise. LSNE is that partner.