Development of an Instrument to Determine Protein Stability at any Desired Temper

开发测定任何所需温度下蛋白质稳定性的仪器

• 批准号: 8062827
• 负责人: Richard Kenneth Brown
• 金额: $ 13.48万
• 依托单位: AVIA BIOSYSTEMS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-01-17 至 2012-01-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8062827
• 关键词: Address; Antibodies; Automation; Biologic Development; Biological; Biological Products; Biotechnology; Buffers; Chemicals; Chimeric Proteins; Data; Data Analyses; Detection; Development; Device or Instrument Development; Differential Scanning Calorimetry; Drug Formulations; Drug Industry; Ensure; Epidermal Growth Factor Receptor; Evaluation; Excipients; Fluorescence; Funding; Goals; High temperature of physical object; Laboratories; Ligands; Marketing; Measurement; Measures; Monoclonal Antibodies; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Predictive Value; Preparation; Principal Investigator; Process; Protein Analysis; Protein Denaturation; Proteins; Recombinant Proteins; Research; Research Personnel; Sales; Sampling; Schedule; Solutions; System; Techniques; Temperature; Testing; Thermodynamics; Time; cost effective; indexing; instrument; programs; protein aggregation; prototype; receptor; research and development; sensor; therapeutic protein

DESCRIPTION (provided by applicant): Protein therapeutics is the fastest growing segment in the biotechnology and pharmaceutical industry. Protein therapeutics includes monoclonal antibodies, recombinant proteins, chimeric proteins and other protein receptor constructs. It is expected to reach over $70 billion in sales by 2010. A major hurdle in the development of proteins as pharmaceutical drugs is their formulation in a safe and stable form. The identification of buffer, ligand and excipient conditions that maximize their stability and eliminate protein aggregation is critical during development and often requires the evaluation of hundreds of conditions. This time-consuming task is compounded by the absence of completely automated instruments with the capability of accurately measuring the stability/aggregation matrix of a protein. The goal of this proposal is to develop a fully automated, protein chemical denaturation, fluorescence/OD instrument aimed at measuring multi-dimensional protein stability and aggregation matrices. In this instrument, the user will only need to provide protein and bulk formulation solutions. The instrument will automatically prepare all solutions, perform the measurements, analyze the data and present the results to the user. PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page 1 PUBLIC HEALTH RELEVANCE: This instrument will significantly accelerate the development of protein therapeutics and find a significant market. In addition, it will provide a new way to study protein stability and aggregation, and contribute to the development of a better scientific understanding of these issues. By providing a rapid and cost-effective means to test Formulations at relevant temperatures (storage and biological), researchers will have the practical opportunity to test more Formulations and to select the Formulation that is optimal for any specific biologic. PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page 1

描述（由申请人提供）：蛋白质治疗是生物技术和制药行业中增长最快的部分。蛋白质治疗包括单克隆抗体、重组蛋白、嵌合蛋白和其他蛋白质受体结构。预计到2010年，其销售额将超过700亿美元。将蛋白质作为药物开发的一个主要障碍是其安全稳定的配方。鉴别缓冲剂、配体和赋形剂条件，使其稳定性最大化，并消除蛋白质聚集，在开发过程中至关重要，通常需要对数百种条件进行评估。由于缺乏能够准确测量蛋白质稳定性/聚集矩阵的全自动仪器，这项耗时的任务变得更加复杂。本提案的目标是开发一种全自动，蛋白质化学变性，荧光/OD仪器，旨在测量多维蛋白质稳定性和聚集矩阵。在本仪器中，用户只需要提供蛋白质和散装制剂溶液。该仪器将自动准备所有溶液，执行测量，分析数据并将结果呈现给用户。PHS 398/2590（09/04修订版，4/2006修订版）第1页