Biologics Analytical Services

Compounds / Materials


Catalent's Large Molecule Analytical services has greater than 20 years of experience supporting various types of biotherapeutic molecules.  Our experience has included support of these biotherapeutic molecules from Pre-IND up to and including Commercial/Phase IV.

  • Catalent can support all stages of development including drug substance, drug product, intermediates (including drug formulation), and associated excipients
  • While Catalent has greater than 20 years supporting Innovator materials, that experience has expanded to additionally support biosimilars and biobetters.
  • Catalent has experience working with many classes of large molecules including but not limited to:
    • Peptides: Conjugated peptides, PEGylated peptides, fusion peptides
    • Proteins: Glycosylated proteins, non-glycosylated proteins, fusion proteins, conjugated proteins, monoclonal antibodies, polyclonal antibodies, bispecific antibodies
    • Oligosaccharides
    • Nucleic Acid Therapies: Oligonucleotides, SiRNA
    • Antibody Drug Conjugates
    • Vaccines
    • Hormones
    • Polymers/Biopolymers
  • Catalent can support materials ranging in all hazard categories comparable to Merck Hazard Categories I-V
  • If needed, Catalent has the DEA license to support Schedule I-IV controlled drugs