MICROHETEROGENEITY IN BIOPRODUCTS

描述(改编自申请者摘要)：创新 旨在提供一种新的方法，用于 微异质产品批次一致性的表征 重组产品。药物的生物效应和效力是 受传统药物的化学结构和 制药公司。标准的分析技术要么不足以 以蛋白质为基础的产品的完整表征或过于昂贵 也很复杂。这份SBIR提案针对的是难以控制的质量 以及与微观异质性相关的表征问题 广泛存在的重组糖蛋白。阿纳利扎提议 制定并验证对这两个过程中都有用的物理化学测试 和最终批次放行分析。建议的方法是独一无二的(在 关于所获得的信息的类型)，数量，昂贵 (相对于目前的方法)、灵活(因为可以使用 对于不同的生物制药)，易于操作且劳动效率高。 该技术提供了一种独特的、高度敏感的信息 糖蛋白结构和构象的微小变化 产品。第二阶段的研究工作旨在证明 提出了一般性的创新建议，以研究相关问题 方法验证，以检查其上游质量的潜力 并开发了初步的自动化控制应用程序 仪器仪表。 建议的商业应用： 这项创新的主要商业应用是在该领域 重组DNA治疗剂的质量控制与质量保证 是在生物技术行业制造的。其他内容 在描述异构性方面的应用展望 密切相关的生物分子混合物，可能对 医学和兽医诊断领域。

DESCRIPTION (adapted from applicant's abstract): The innovation described in this proposal is aimed to 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 pharmaceuticals. 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 and characterization problems associated with microheterogeneity of widely available recombinant glycoproteins. ANALIZA is proposing to develop an validate a physico-chemical test useful for both in-process and final lot release analyses. The proposed methodology is unique (in regard to the type of information obtained), quantitative, in expensive (relative to present methodologies), flexible (in that is may be used for different biopharmaceuticals), 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. Phase II research effort is designed to demonstrate the generality of the proposed innovation, to study issues related to method validation, to examine its potential for up-stream quality control applications and to develop a preliminary automated instrumentation. PROPOSED COMMERCIAL APPLICATION: The principal commercial applications of this innovation are in the area of quality control and assurance of recombinant DNA therapeutical agents that are manufactured in the biotechnology industry. Additional applications are envisioned in characterization of heterogeneous mixtures of closely related biomolecules that may be of importance to both the medical and veterinary diagnostics fields.