MICROHETEROGENEITY IN BIOPRODUCTS

描述（改编自申请人的摘要）：创新 本提案中描述的目的是提供一种新的方法， 微异质性的批间一致性表征 重组产物。药物的生物效应和效力是 受传统药物和 大药厂标准的分析技术要么是不够的， 用于蛋白质基产品的完整表征或成本太高 也很复杂此SBIR提案针对的是困难的质量控制 和表征问题与微观异质性的 可广泛获得的重组糖蛋白。Analiza建议 开发一个验证一个物理化学检测，用于过程中 和最终批放行分析。所提出的方法是独特的（在 关于获得的信息的类型），定量，昂贵 （相对于目前的方法），灵活（即可以使用 用于不同的生物制药），易于执行且劳动效率高。 该技术提供了一个独特的和高度敏感的信息， 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 建议创新的一般性，研究有关问题， 方法验证，以检查其对上游质量的潜力 控制应用程序，并制定了初步的自动化 仪器仪表 拟定商业应用： 这一创新的主要商业应用是在该领域 重组DNA治疗剂的质量控制和保证 在生物技术产业中生产的。额外 应用设想在表征异质 密切相关的生物分子的混合物， 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.