John J. Buckley, Global Biologics, Pfizer, Inc., Chesterfield, MO 63017
Processing challenges presented by a PEGylated peptide are discussed. Considerations encountered in chromatography elution design and difficulties in handling of PEGylated peptides in UFDF operations are discussed. The effects of PEG conjugation are discussed in relation to properties of the resulting drug substance, processing characteristics, and formulation limitations.