The progress in understanding and addressing the challenges of impurities was a key focal point of this year’s USP Therapeutic Peptides and Oligonucleotides Workshop, held virtually on February 28, March 2 and March 4, 2022.
PART I: US and European Regulator Perspective on the CMC Challenges of Oligonucleotides
PART II: USP Standards Development Efforts for Peptides and Oligos
PART III: Peptide and Oligo Analytical, Manufacturing and Raw Material Considerations