Formulation Development

Utilizing a proven formulation process, Curia approaches formulation development of biologics in a pragmatic manner designed to produce a robust data package to validate formulation decisions.

This bespoke approach utilizes highly efficient, fully integrated formulation development programs that are designed to better understand the needs of the specific molecule. Heavy emphasis is placed on defining critical quality attributes and ultimately, designing a formulation with ICH stability guidelines and manufacturability in mind. This approach reduces the risk of costly reformulation at later stages and facilitates streamlined tech transfer.

Curia approaches each formulation project with the commercial product in mind. Whether your goal is to out-license or follow through to commercialization, we can help you quickly develop a formulation that achieves manufacturability and maximizes value.

Key Highlights

Preliminary Formulation Development for Drug Candidates

  • Formulation studies can be completed in 8 weeks (with potential earlier decisions based on data), including standard accelerated stability and acute stress studies
  • Designed to generate actionable data and earlier clinical formulation candidates
  • Understand significant, relevant physicochemical properties
  • Develop stability-indicating assays for major degradation products
  • Decide upon a lyophilized or liquid formulation for initial clinical studies

Formulation Optimization

  • Data-driven approach based on results from preliminary characterization
  • Pointedly-address critical quality attributes
  • Commercial formulation and IP competitiveness, finalize presentation, etc.

High Concentration Formulation Development

  • Technologies developed by Curia scientists improve high concentration formulations
  • Common issues include viscosity reduction, soluble/insoluble aggregate reduction

Lyophilized Formulation Development

  • When better product stability is required, lyophilization may be preferred
  • Goals include good stability during freeze-drying process, efficient lyophilization cycle, elegant appearance of the lyophilized cake, rapid and thorough reconstitution, etc.
  • Lyophilization cycle optimization

Building Efficiency into Biologics Formulations Development

Often, aggressive timelines are imposed on development projects with the aim of getting to First-in-Human trials as soon as possible. However, formulation development can be met with many challenges as biologics are often sensitive molecules with a variety of competing degradation possibilities.

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