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Manufacturing of cGMP Clinical Batches

Belrose can provide its Collaboration Partners with cGMP clinical batches. This cGMP clinical batch manufacturing generally follows successful Proof of Concept and Formulation Development activities.

Range of Molecule Types

Belrose can provide its Collaboration Partners with cGMP clinical batches for innovative therapeutics that contain single molecules and/or combinations of multiple molecules, including:

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

Belrose can deliver cGMP clinical material, with or without lyophylization, generally for Phase l and Phase II studies. Belrose has the capability to manufacture and package cytotoxic materials, including proprietary Antibody Drug Conjugates (ADCs), which are manufactured using 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


Associated Services

Belrose is able to provide the support generally required for clinical study management, including:

  • Assistance calculating needs for Tox/Preclinical and Stability Studies
  • Ensuring packaging meets clinical program needs and addressing “non-standard” requirements
  • Clinical labeling/packaging
  • Supporting serialization and randomization
  • Facilitating release by a “Qualified Person” (QP)