SBIR Phase II: Novel Method for Class Switching IgM Secretors to IgG

这项小型企业创新研究（SBIR）二期项目建议开发一种快速的IgSwitch实验，利用体外培养条件、微胶囊化技术和荧光激活细胞分选，从IgM杂交瘤中诱导和分离IgG类开关变异。IgSwitch实验有望对用于分离类开关变异的传统方法进行重大改进，并将在细胞系发育和单克隆抗体生产中发挥作用。先前的I期研究已经使用模型IgM杂交瘤证明了所提出方法的可行性。该二期项目将开发促进向不同IgG亚类转换的体外培养条件。II期研究还将验证一系列同型特异性IgSwitch检测试剂。该项目的商业应用将在单克隆抗体领域。在单克隆抗体生产中使用靶向IgSwitch Assay将有助于从大量未开发的IgM杂交瘤来源中产生新的IgG特异性抗体，用于研究、治疗、诊断和成像试剂。

This Small Business Innovation Research (SBIR) Phase II project proposes to develop a rapid IgSwitch Assay for inducing and isolating IgG class switch variants from IgM hybridomas using in-vitro culture conditions, microencapsulation technology and fluorescence activated cell sorting. The IgSwitch Assay is expected to be a significant improvement over conventional methods used to isolate class switch variants, and will be useful in cell line development and monoclonal antibody production. Prior Phase I research has already demonstrated the feasibility of the proposed method using a model IgM hybridoma. This Phase II project will develop in-vitro culture conditions that promote switching to different IgG subclasses. The Phase II research will also validate reagents for a family of isotype specific IgSwitch Assays. The commercial application of this project will be in the area of monoclonal antibodies. Use of the targeted IgSwitch Assay in monoclonal antibody production will help to generate new IgG specific antibodies from a largely untapped source of IgM hybridomas, for potential use as research, therapeutic, diagnostic, and imaging reagents.