The NISTmAb: A Reference Material to Supplement Biopharmaceutical Characterization John Schiel, NIST Monoclonal antibodies (mAbs) are the fasted growing class of therapeutics. The quality and consistency of each production lot is ensured by comparison with an in-house reference standard representative of the therapeutic product and development process. During a drug’s lifecycle, the inhouse reference standard must co-evolve with process changes as well as changing/evolving analytical test methods. Qualification of test methods as well as in-house reference standards would be greatly supplemented by a widely available representative test material. This presentation will discuss the establishment of an IgG1k Reference Material expected to more firmly underpin regulatory decisions and facilitate the development of originator and follow-on biologics. The RM is intended for a variety of uses including, but not necessarily limited to: establishing method or instrument performance and variability, comparing changing analytical methods, assisting in method qualification, etc. The NISTmAb characterization and certification will be discussed in association with potential utility during an originator or follow on manufacturer’s process/product development process. Global conclusions drawn from the unprecedented industry-wide book collaboration “State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization” will also be presented. Learning Objectives: 1. Describe the intended NIST/industry partnership for facilitating innovation in US Healthcare. 2. Present the totality of product knowledge collected on the NISTmAb. 3. Highlight industry-wide advantage to collaborative testing on a widely available Reference Material. 4. Discuss and identify new avenues for NIST/industry collaboration and/or reference materials that may facilitate biopharmaceutical development.