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Formulation Development

Expert Driven Drug Development

Formulation Development for Advanced Therapies

Cell and gene therapies present unique formulation challenges that require innovative and data-driven design strategies to preserve safety, efficacy and stability. Landmark Bio has a suite of services to meet the formulation complexities imposed on novel advanced therapies from nucleic acids to cell-based therapies and everything in between.

Whether your objective is to identify a nanoparticle composition suitable for your cargo of choice or a buffer composition that maintains viability of your advanced therapy before and after cryopreservation, Landmark Bio has the in-house expertise and capabilities to ensure your product’s mechanism of action remains intact throughout development and manufacturing.

Landmark Bio’s comprehensive and phase-appropriate development services will safeguard the authenticity, integrity, and efficacy of your program and ensure cGMP-readiness

Formulation Services for Nanomedicines

Formulation development: rational design of nanoparticle formulations (lipid and non-lipid based) to enhance stability and for efficient encapsulation or conjugation of diverse cargos.

  • Nanoparticle composition
    • Encapsulation Efficiency
    • Stability
  • Buffer/excipient composition
  • Stability studies and optimization
    • Controlled-rate freezers
    • Simulated shipping studies
  • Identification, assessment, selection, testing, and sourcing of final formulation critical raw materials

Formulation Services for Cell Therapies & Viral Vectors

Formulation development: rational design of buffer/excipient composition, cryopreservation parameters and stability studies

  • Research and cGMP cryopreservation
  • In-house analytics to develop and quantify quality attributes before and after cryopreservation
  • Controlled-rate freezing development and execution in cGMP and non-cGMP environments
  • Identification, assessment, selection and sourcing of final formulation critical raw materials
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