Senior Principal Scientist Merck & Co. Scotch Plains, New Jersey
Islatravir is a late stage candidate for the treatment and prevention of HIV infection. We have developed an efficient synthesis of islatravir from simple building blocks that depends on a nine enzyme cascade wherein approximately 200g of protein is used for every kilogram of active ingredient produced. This is a through process with no isolated intermediates, placing a significant burden on removal of residual protein from the final product. The level of acceptable residual protein will depend on the route of administration which presented significant analytical challenges to ensure sufficient removal of the residual enzymes. This presentation will cover how these challenges were met for this candidate.
Learning Objectives:
Understand techniques for removing residue protein from active pharmaceutical ingredients produced via enzymecatalyzed processes.
Learn about potential techniques for detecting low leves of residual protein.
Understand methods for releasing enzymatic catalysts for use in GMP manufacturing
