Whether you need to develop a new formulation or optimize an existing one, PMI Bio has the experience and capabilities to achieve your target parenteral, oral, topical, or lyophilized drug product.

Our preformulation, excipient, and formulation studies expose the project’s complexities so we can plan the most efficient way to speed your compound toward commercialization. Experience gives us the edge in selecting the right ingredients, identifying potential stability problems, confirming stability of the API under manufacturing conditions, and ensuring compatibility with container/closure systems.

We also provide vehicle delivery studies for poorly water-soluble APIs in emulsions and suspensions.

Our goal is to cost-effectively develop a formulation that delivers your compound as desired, preserving critical quality attributes while withstanding today’s intense regulatory scrutiny.

Capabilities

  • Admixture and container/closure compatibility studies
  • Critical process parameters evaluation
  • Degradation
  • Development report in support of CMC
  • Excipient compatibility studies
  • Liposome and microsphere encapsulation
  • Potency
  • Solubility and pH
  • Thermal analysis

Liquid and Semi-Solid Dosage Forms

  • Oral solutions and suspensions
  • Parenteral solutions and suspensions
  • Topical solutions and semi-solids

“Our team will evaluate your process and identify efficient and cost-effective routes to production, reducing process waste and maximizing yield, without sacrificing quality.”

Nathan Burleson

BS in Biology

  • Supports cGMP manufacturing
  • Specialties: Formulations and tech transfer, process development, improvement and scale-up, and bulk and aseptic production
  • 6 years’ industry experience, certified in Lean design — Six Sigma Green Belt
  • Redesigned a cream heating and cooling system for faster heating and cooling with improved temperature control
  • Passions: Reading, golf, and additional sporting events