NIST Releases New Reference Material to Aid Biopharma Quality Control

USA: NIST Releases New Reference Material to Aid Biopharma Quality Control

The National Institute of Standards and Technology (NIST) announced on July 31, 2025 the availability of a new standard reference material designed to improve detection of particulate contaminants in protein‑based biotherapeutic drugs, addressing a critical need for consistent quality control across the industry.

Background on Protein‑Based Biotherapeutics

Protein‑based biotherapeutics, which include treatments for cancer, genetic and autoimmune disorders, are manufactured by genetically engineered cells that produce large protein molecules. During production, storage, or transport, these proteins can aggregate into visible particles that may trigger immune responses in patients, prompting manufacturers to inspect each vial for such contaminants.

Details of the New Reference Material

The newly issued Standard Reference Material (SRM 1989: Monodisperse Irregularly Shaped Epoxy‑Based Particles) consists of three vials containing particles sized at 220 micrometers, 150 micrometers and 100 micrometers, respectively. The particles are irregular in shape, transparent, and engineered to mimic the visual characteristics of protein aggregates.

Applications in Quality Control

According to NIST research chemist Srivalli Telikepalli, the SRM will be incorporated into training kits to standardize visual inspection and can also be used by instrument manufacturers to calibrate automated detection systems. Consistent use of the material is expected to reduce subjective interpretation among analysts and lower the risk of unnecessary batch discarding.

Production Methodology

The particles were fabricated at NIST’s Center for Nanoscale Science and Technology using photolithography—a technique traditionally employed to create microscopic circuits on silicon wafers. Ultraviolet light hardened an epoxy‑like coating on a silicon wafer, forming a patterned array of particles that were later harvested into a liquid suspension.

Industry Implications

NIST has produced more than a thousand SRMs supporting sectors ranging from health and medicine to semiconductor manufacturing. The biopharmaceutical market, projected to expand from an estimated $666 billion in 2025 to $1,184 billion by 2032, stands to benefit from the enhanced measurement precision the SRM provides.

Access and Distribution

SRM 1989 is now available for purchase through the NIST Store, offering manufacturers and laboratories a publicly accessible tool for improving particle detection and ensuring product safety.

This report is based on information from NIST, licensed under Public Domain (U.S. Government Work). Source: Official U.S. Government release.