Formulation Development

Formulation Development

We offer first-in-human formulation development, and we can supply material for preclinical studies and conduct research-level stability studies. We work with all product types, from small to large molecules, highly viscous products, suspensions, and sensitive formulations. Our goal is to develop a formulation process that will repeatedly achieve defined quality attributes you need for your clinical study, and that can serve as an effective process through commercialization.

Our process engineering team will optimize your formulation, develop an effective and optimized process, and perform scale up studies. We use materials and equipment representative of future GMP manufacturing.

Information gathered during formulation development is shared with our quality control group to allow them a head start in their analytical method feasibility, evaluation, and development.

Services we provide:

  • Determine order of addition
  • Mixing optimization
  • Formulation scale-up
  • Excipient compatibility studies
  • Tech Transfer
  • Holding time/ Reconstitution studies
  • Freeze-thaw studies

What we work with:

  • Small & large molecules (peptides, oligonucleotides, proteins, and more)
  • Highly sensitive formulations (oxygen, light, and/or shear-sensitive products)
  • Highly viscous solutions
  • Aqueous and nonaqueous solutions
  • Suspensions (aqueous and nonaqueous)
  • Poorly soluble compounds
  • Emulsions
  • Lyophilized powders
  • Nanoparticle-based formulations (i.e., liposomes, polymeric nanoparticles, and LNPs)

Upcoming Webinar:

Wednesday, January 18 | 1PM EST

Why your container & closure choice matter in sterile fill finish