NIST Engagement with Outside Stakeholders

The three program goals (protein stability, protein structure, and production-cell variability) are based on discussions with the FDA and industry and have been determined to be critical areas in which NIST measurement tools will provide useful data.

As stated above, work on protein stability in collaboration with a major pharmaceutical company has taken advantage of the NIST NCNR to develop new tests for the efficacy of proteins stabilized by various glycerol formulations. Also as noted above, in the area of protein structure, NIST has excellent resources available internally and through its 20-plus-year relationship with the University of Maryland’s IBBR.

Work on production-cell variability is the least-developed program goal. The manufacturing of biologic drugs in living cells, such as CHO cells, is a critical process in the pharmaceutical industry, and controlling product consistency is a significant challenge. Thus, identifying new measurement methods and tools for quantifying and controlling cellular machinery is an admirable NIST goal. There is little doubt that NIST technologies could be invaluable here. What remains is to develop a clear strategy to execute, which will engage the appropriate external stakeholders. This strategy should be forthcoming.

Program Coordination and Cohesion

Overall, the Biomanufacturing initiatives are appropriately focused in the short term on protein therapeutics, consistent with the strengths of the Material Measurement Laboratory. The Biomanufacturing group is encouraged to explore and foster crosscutting initiatives with other manufacturing groups, especially Nanomanufacturing. For instance, nanofabrication of engineered therapeutics is an area of emerging importance. Recent breakthroughs using materials specifically designed for imprint or soft lithography have enabled flexible methods for the direct fabrication and harvesting of monodispersed, shape-specific nanobiomaterials. These nanoparticles can be fabricated into numerous shapes and sizes, including nanocylinders, nanorods, or long, filamentous, “worm-like” nanoparticles. The unique control over size and shape leads to a variety of nanomaterials that can accumulate in specific tissues or diseased sites. This area could constitute an important crosscutting effort.

Careful integration with other complementary NIST efforts will potentially lead to a robust and valuable program.

RECOMMENDATIONS

The recommendations for the Nanomanufacturing area, including Biomanufacturing, are the following:

1.   NIST should continue to define its vision for its Nanomanufacturing program, making clear choices about what nanomanufacturing should be on the basis of the NIST mission. To have more impact, NIST should focus on the following definitions or aspects of nanomanufacturing:

•   Making nanoscale objects to obtain special properties, and

•   Using nanotechnology to manufacture other things.



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