MICROHETEROGENEITY IN BIOPRODUCTS

生物产品中的微观异质性

• 批准号: 2332127
• 负责人: BORIS Y ZASLAVSKY
• 金额: $ 9.99万
• 依托单位: ANALIZA, INC.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-01 至 1997-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2332127
• 关键词: biological products; drug quality /standard; fluorimetry; glycoproteins; method development; recombinant proteins; spectrometry

The innovation described in this proposal is aimed at providing a new method for characterization of lot-to-lot consistency of microheterogeneous recombinant products. The biological effect and potency of a drug is governed by the chemical structure for both traditional drugs and biopharmaceuticals. Standard analytical techniques are either inadequate for complete characterization of protein-based products or too costly and complex. This SBIR proposal is targeted at difficult quality control problems associated with microheterogeneity of widely available recombinant glycoproteins. ANALIZA is proposing to develop and validate a physicochemical test that is unique (in regard to the type of information obtained), quantitative, inexpensive (relative to present methodologies), flexible (in that it may be used for different biologicals), easy to perform and labor-efficient. The technique provides a unique and highly sensitive information on minor changes in the structure and conformation of the glycoprotein product related to its potency. Phase I research effort is designed to demonstrate feasibility of the suggested technique as a QA/QC test by developing and validating the proposed analytical methodology for analysis of a biopharmaceutical product to be determined with biopharmaceutical collaborators. PROPOSED COMMERCIAL APPLICATION: A new analytical technology that improves the control of safety and efficacy of glycoprotein-based drugs offers significant benefits given the increasing use and variety of such products on the market. The proposed method may reduce manufacturing costs and effort, while increasing safety and efficacy control of the products by providing a rapid, simple, and sensitive test for QC/QA monitoring of recombinant and other biological glycoprotein-based products.

本提案中所述的创新旨在提供一种新的 表征微异质材料批间一致性的方法 重组产物。药物的生物效应和效力是 受传统药物和 生物制药标准的分析技术要么是不够的， 对于基于蛋白质的产品的完整表征而言， 复杂.此SBIR提案针对的是困难的质量控制 与广泛可用的重组体的微观异质性相关的问题 糖蛋白ANALIZA建议开发和验证一个 唯一的物理化学试验（就信息类型而言 获得）、定量、廉价（相对于目前的方法）， 灵活（因为它可以用于不同的生物制剂），易于 工作效率和劳动效率。该技术提供了一个独特的和高度 结构和构象微小变化的敏感信息 糖蛋白产物与其效力的关系。第一阶段研究工作 旨在证明所建议的技术作为 通过开发和验证拟定的分析方法进行QA/QC测试 用于分析待测定的生物制药产品， 生物制药合作者。 拟议的商业应用：一种新的分析技术， 对糖蛋白类药物的安全性和有效性的控制 鉴于此类产品的使用和种类不断增加， 市场上所提出的方法可以降低制造成本， 努力，同时通过以下措施提高产品的安全性和有效性控制 为QC/QA监测提供快速、简单和灵敏的检测， 重组和其他基于生物糖蛋白的产品。