Monoclonal antibodies (mAbs) are the fasted growing class of

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.