Developing And Commercializing Efficient And Effective PEGylation Processes

By Rebecca Abram, Balazs Major, Jackie Swinbourne, Steve Loftus, James Pullen

The future of conjugation and PEGylation in biologics is promising, with advancements focused on enhancing drug efficacy and reducing immunogenicity. Many emerging strategies involve site-specific attachment of therapeutic molecules to biologics, minimizing off-target effects.

FUJIFILM Diosynth Biotechnologies (FDB) is a CDMO with a rich history and extensive experience in navigating our clients through development challenges for PEGylated microbial therapeutics. We support both liquid and solid conjugation chemistries that include reactions with amino acid side chains and backbone, as well as chemistries involving non-proteinogenic amino acids at fermentation volumes up to 3000 L. Our expanding capacity and end-to-end service has made us the partner of choice for clients on their journey to commercialization.

This article outlines more detail on efficiencies of scale, integrated heterogeneity assessments, characterization and stability services, and the creation of control strategies that last the entire lifecycle of your molecule.