Living Cell Reference Material Aims to Speed Monoclonal Antibody Development

USA: Living Cell Reference Material Aims to Speed Monoclonal Antibody Development

The biopharmaceutical sector may soon benefit from a new living reference material that provides a continuous supply of Chinese hamster ovary (CHO) cells engineered to produce a well‑characterized monoclonal antibody (mAb). Developed by the National Institute of Standards and Technology (NIST) in partnership with MilliporeSigma and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), the material was released in September 2025 to support quality‑assurance testing and process optimization across the industry.

Why a Living Reference Material?

Monoclonal antibodies are produced in living cells, and subtle variations in the manufacturing process can affect drug safety and efficacy. Traditional reference standards, such as the NIST Monoclonal Antibody (NISTmAb) protein, represent the final product but do not reveal how upstream steps influence quality. By offering a living cell line that continuously generates the same antibody, manufacturers can evaluate bioreactor designs, culture media, purification methods, and storage conditions in real time.

How NISTCHO Was Created

Scientists inserted the genes encoding the NISTmAb protein into CHO host cells and performed clone selection to identify a single cell line that combined rapid growth with high antibody yield. The chosen clone, now known as NISTCHO, is packaged as Reference Material 8675, containing one milliliter of solution with approximately 10 million cells. Rigorous genetic testing ensures that the ratio of antibody‑coding genes to other genomic regions remains consistent across vials, providing a reproducible baseline for measurement.

Industry Implications

According to NIST biologist Zvi Kelman, the living reference material enables biopharmaceutical companies to “optimize their manufacturing processes and quality‑assurance methods,” potentially shortening development timelines for lifesaving drugs. Equipment manufacturers can also use the material to benchmark new cell‑culture media, analytical hardware, and bioreactor designs, fostering a more skilled workforce in biomanufacturing.

Market Context

The global market for monoclonal antibodies was valued at $249 billion in 2024 and is projected to exceed $619 billion by 2031. Accelerating development and ensuring consistent product quality are therefore critical objectives for an industry that supplies therapies for cancers, autoimmune disorders, and a range of chronic conditions.

Comparison with Existing Standards

Unlike the earlier NISTmAb protein, which must be purchased anew for each test, NISTCHO offers a renewable supply, eliminating the need for repeated shipments from the institute. This shift from a single‑use material to a living reference resource aligns with broader trends toward sustainable and cost‑effective research tools.

Future Directions

Researchers anticipate that the living reference material could be expanded to include additional therapeutic proteins or engineered cell lines, further broadening its applicability. Continued collaboration between standards organizations, biotech firms, and academic laboratories will be essential to maintain the material’s relevance as manufacturing technologies evolve.

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