Last fall, KNect365 brought together more than 250 analytical specialists to discuss biological assays and characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies for case studies, regulatory interactions, sharing perspectives, and learning about emerging technologies. Part 1 of this report in January 2019 focused on the bioassay section of the meeting. Here in Part 2 sponsored by Sartorius, BPI’s senior technical editor reports on the “Well-Characterized Biologics” tracks. As you make plans for attending conferences this fall, consider the next installment of this series in Reston, VA, on 11–13 November 2019 — and contribute to the ongoing discussions.

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