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
- Nucleic Acid Therapies: Oligonucleotides, SiRNA
- Antibody Drug Conjugates
- 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