CCDG Dinner Lecture

Join us for a dinner and networking event Wednesday June 24, 2026 at the Westwood Tavern in Schaumburg, IL.

Presentation Description:

The biopharmaceutical industry continues to expand rapidly, driving innovation and research with market values now reaching into the billions. Within the commercial world for biopharmaceuticals, one cannot avoid hearing about peptides, oligonucleotides, or monoclonal antibodies and the impact synthetic drugs have had on consumer health. Alongside innovators, generic manufacturers play a critical role by developing bioequivalent biosimilars that reach the market quickly at more affordable prices. To support this need for generics as well as for innovators, the United States Pharmacopeia (USP) has introduced new chapters for synthetic biologics testing and monographs for select peptide analyses to ensure their identity, strength, purity, and performance. As larger and more complex biomolecules become more common, understanding USP–NF monographs and the allowable adjustments under ⟨621⟩ is essential to developing compliant, robust, and accurate chromatographic methods for commercial products. Within this presentation, we will discuss the USP-NF compendial, the recent additions of biologic chapters, working with USP monographs, and discussing <621> for allowable adjustments to liquid chromatography.