Working with USP Methods and the updates to ⟨621⟩ : Allowable AdjustmentsAbout this Event
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.
Bio:
Robert Moeller obtained his bachelor's and master's degrees in chemistry in Analytical and Physical Chemistry at the University of Michigan, Ann Arbor in 2020. His undergraduate and graduate research ranged from developing NLP tools to score and identify cognitive operations and complex reasoning in student chemistry essays, to investigating porous polymer monoliths for solid-state chromatography in small-scale on-chip devices.
For the last five years, Robert has worked within the cGMP regulatory laboratory space across generic pharmaceuticals and CROs in Michigan. His recent employment was with the Food & Drug Administration (USFDA) within their medical products laboratory in Detroit, MI. Within the FDA, he performed analytical testing for the Department of Defense, compliance testing of imported and domestic products for consumer safety, and FDA inspections of drug manufacturing facilities for compliance to 21 CFR Part 210 and 211.
He is now currently employed with Phenomenex as their Biopharmaceutical Business Development Manager for the Midwest. Within his role, Robert is responsible for developing and expanding current and new relationships with scientists and innovators across the biopharmaceutical industry and providing educational materials on complex large biomolecule analysis.
In his free time (if he ever has any), he enjoys making homebrews, ice-skating, playing music, and spending time with his wife, friends, and family, including his new baby niece.
Event Venue
Westwood Tavern, 1385 North Meacham Road, Schaumburg, United States
USD 15.00 to USD 25.00
