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NIST develops new reference materials to improve biological drug quality and manufacturing

By PulseAugur Editorial · [2 sources] ·

NIST has developed two new reference materials to enhance quality control in the biopharmaceutical industry. One is a living reference material, NISTCHO, which produces monoclonal antibodies and allows manufacturers to optimize their production processes. The other is a standard reference material, SRM 1989, consisting of precisely sized particles designed to help detect and quantify impurities in protein-based drugs. These materials aim to accelerate drug development, ensure drug safety and efficacy, and reduce manufacturing costs by improving the accuracy and uniformity of quality control measures. AI

RANK_REASON NIST, a government research agency, released new standard reference materials for the biopharmaceutical industry.

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AI-generated summary · Google Gemini · from 2 sources. How we write summaries →

NIST develops new reference materials to improve biological drug quality and manufacturing

COVERAGE [2]

  1. NIST News TIER_1 English(EN) · Sarah Henderson ·

    NIST’s ‘Living Reference Material’ Could Accelerate R&D of Lifesaving Biological Drugs

    The NIST reference material, called NISTCHO, will help the biopharmaceutical industry develop new drugs more quickly and ensure that they are safe and effective.

  2. NIST News TIER_1 English(EN) · Sarah Henderson ·

    New NIST Reference Material to Strengthen Quality Control for Biological Drugs

    Impurities in these drugs can cause undesirable immune responses in patients and can significantly drive up costs for drug manufacturers.

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