A comprehensive lifecycle management program including a two-tiered in-house reference standard approach was modeled after industry best practices . In order to serve as a common framework for pre-competitive innovation, a Reference Material must be shown to be homogeneous, stable, and fit for its intended use. The current manuscript describes in detail the stratified sampling plan that was used in association with rigorously qualified analytical methods to assign reference values and ensure the quality of the NISTmAb RM 8671 [9, 11, 12]. Reference value assignment was performed in concert with the in-house primary sample PS 8670 as a system suitability control, the material for which the most historical analytical and biophysical attribute information was available [6–8]. The initial methods selected were intended to be those that were most pertinent to the stakeholder in ensuring a quality material, and thus included chemical and colloidal stability/purity indicating assays along with a comprehensive primary amino acid sequence confirmation.