Standards for Biomanufacturing

An overarching problem confronting the development, manufacture, and regulatory approval of complex biotechnology medicines (e.g., protein, cell, gene, and nucleic acid therapies) is that these products cannot currently be adequately defined by measurement. This gap leads to uncertainty in determining the consistency of products from different manufacturing batches or processes, and assessing the similarity of originator products to their biosimilar or ‘generic’ counterparts.

To address the critical need, researchers at IBBR are developing a suite of fundamental measurement science, standards, and reference data as part of NIST’s Biomanufacturing Program to enable more accurate and confident characterization of key attributes of biologic drugs.  By providing tools to enable a more accurate and precise assessment of the composition, structure and stability of biologic drugs, the program aims to: (1) provide a firm scientific underpinning for FDA regulatory decisions; (2) enable innovation in biopharmaceutical development and next-generation biologic therapeutics discovery; and (3) facilitate the development of biosimilars to lower healthcare costs and increase access to lifesaving medications.

The Biomanufacturing Program was developed through close working relationships with key stakeholders including the biopharmaceutical industry, the FDA, international regulatory and standards organizations, and academia to assess and authenticate current unmet and future measurement needs related to the manufacturing of biologic drugs.  Program partnerships are built and strengthened through workshops and roundtable discussions to assess emerging trends and measurement needs, inform stakeholders of NIST capabilities, and leverage critical expertise not present at NIST.

The researchers at IBBR involved in the Biomanufacturing Program are primarily focused on advancing measurement tools to assess structure and post-translational modifications (PTMs) of biologic drugs.  Research activities include the conducting of inter-laboratory studies for method harmonization and validation; performance of physicochemical characterization of therapeutic protein identity, quality, and stability; and the development and curation of reference materials and data for use by industry and regulatory agencies.