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Proof of Concept & Formulation Development

Based on its understanding of each specific opportunity, Belrose works with partners to help develop a streamlined approach to complete proof of concept development activities, which generally involve a “Design of Experiments” designed to test the impact of varying specific development/formulation parameters.

Range of Molecule Types and Technologies

The Belrose technical and management team has significant experience developing new therapeutics and helping established companies implement life cycle management strategies for approved products, including:

  • Proteins
  • Peptides
  • Antibody fragments
  • Antibodies
  • Oligonucleotides/SiRNAs
  • Small molecules
  • Compounds with low solubility

Depending on the specific needs to advance any given program, Belrose can help its COLLABORATION PARTNERS increase a clinical candidate’s bioavailability, solubility, half-life and other clinical characteristics by drawing on one or more of the following techniques:

  • Permanent PEGylation
  • Releasable PEGylation
  • Other proprietary formulation strategies
    • Polymer conjugation/ complexation
    • Nanoparticles including PEG and/or Lipids
    • Engineered proteins/ antibodies (chimerized)
    • Lipid and liposome-based formulations
    • Other formulation technologies as appropriate


Formulation Assistance

In order to help Collaboration Partners address product suitability issues, Belrose can also:

  • Complete stability data assessment to predict stability of a given drug formulation
  • Help with Lyo development for lyophilized formulations, including multi-use vials, pre-filled syringes and auto-injector formats.