Nested syringes undergoing sterile filling

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. 

Aseptic Formulation

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)
  • Diafiltration
  • Microfluidization/High Pressure Homogenization
  • Aseptic Ball Milling
QC ensuring safe manufacturing of prefilled syringe

Complex Process Engineering

We understand no process is the same and take a thoughtful approach to transfer complex manufacturing processes to our GMP facilities.

Are you in the early stages of development and need scale-up?

We can develop aseptic formulation processes from scratch or scale-up your lab-scale process to GMP and get your product into the clinic.

Looking for a new home for your product and need to transfer an existing manufacturing process?

Our technical SME’s will work with you to understand the utility requirements of your equipment train so we can safely transfer the process under our systems and procedures.

Analytical Testing

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
  • Ribogreen
Analytical testing service to support the development and GMP manufacturing