Manufacturing & Support Services >> Development & Validation >> Formulation Development

Formulation Development

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Eurofins BioPharma Product Testing provides drug product development services with expertise that includes peptide biological proteins, RNAs, DNAs, and small molecules (organic and inorganic). We can rapidly develop a formulation that is best suited for your drug development program and also provide submission-ready documentation. If you are developing a new drug product or reformulating, our team routinely supports injectables, nasal sprays, topical products, ophthalmics, emulsions, and nebulized solutions.

Our goal with each formulation development project is to quickly and cost-effectively identify a stable and pharmaceutically elegant dosage form that is optimal for the therapeutic indication and the intended route of administration. We focus on developing a formulation that is the best for the drug program itself and the Sponsor's development strategy. We have expertise formulating with new chemical entities or reformulating existing drugs, including biosimilars.

Pre-formulation

Our pre-formulation capabilities include:

  • Spectroscopic characterization (IR, UV-vis, fluorescence, MS, XRPD)
  • Chemical characterization (residual solvents, residual water, counter-ion content, chromatographic purity, elemental analysis)
  • Physical characterization (thermal transitions, hygroscopicity, pKa, pI)
  • Solubility characterization (water, solvents, aqueous versus pH, logP, salt selection)
  • Compatibility characterization (with bags, pumps, ports, filters, sets, etc.)
  • Stress Stability characterization (short-term stability under stress conditions versus pH)

Reformulation or Formulation Optimization

Eurofins BioPharma Product Testing has expertise formulating with new chemical entities or reverse engineering and reformulating existing drug products. We specialize in overcoming technical barriers associated with difficult-to-formulate API’s, such as those that are poorly soluble or unstable.

Our experience supporting reformulation or formulation optimization for Sponsors seeking to evaluate production alternatives or enhance patent protections includes:

  • Lyophilized solution to stable liquid
  • Liquid to semi-solid for topical application
  • Excipient substitutions