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Articles

Certification of Standard Reference Material® 1989 Monodisperse Irregularly Shaped Epoxy-Based Particles (Nominal 100 µm, 150 µm, 220 µm)

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By Srivalli Telikepalli, Dean C. Ripple, Michael Carrier, Kristen Steffens
| nist.gov
, Dean Ripple, , , , , , , Standard Reference Material (SRM) 1989 is a NIST particle standard produced using photolithographic methods and delivers a certified value for particle size of an irregularly shaped particle. This SRM was developed to allow a more accurate monitoring of visible protein-like particles that may be found in biotherapeutics.
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Humanized Monoclonal Antibody IgG1k, NISTmAb RM 8671 Summary of 5 Year Stability Verification (5YSV)

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By John Schiel, Katharina Yandrofski, Trina Mouchahoir, Srivalli Telikepalli
| nist.gov
Author(s) , , , , , , , , Abstract NISTmAb RM 8671 is an IgG1κ monoclonal antibody that has been extensively characterized and released as the first of its kind biopharmaceutical reference material in 2016. This material was intended primarily for use in evaluating the performance of methods for determining physicochemical and biophysical attributes of monoclonal antibodies.
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